Early Detection of Five Common Cancers Using the ctDNA Analysing Test

NCT05227261 | Completed DMC

• 1 other identifier: 02GS
• Study Type: observational
• Target: 9,057
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multi-centre, prospective cohort study, aiming to evaluate a blood test in early detection of the four common cancers, based on the investigation of the circulating tumour DNA (ctDNA). Primary objective: To evaluate the performance characteristics of the blood ctDNA test in early detecting cancers. Secondary objectives:

• To evaluate the performance characteristics of the test in determining the origin of tumour, as compared to the findings of the imaging diagnostic tests.
• To determine the risk of cancers development in the high-risk population, as compared to that in the moderate-risk group.

Conditions

Cancer, Lung; Cancer, Breast; Cancer Liver; Cancer, Colorectal; Liquid Biopsy; Circulating Tumour DNA; Cancer, Gastric

Keywords

Early cancer detection; Circulating Tumour DNA; Liquid biopsy; Vietnam

Outcome Measures

Primary Outcomes (2)

• Positive predictive value, Negative predictive value of the blood ctDNA test in early detecting cancers

  12 months following enrolment

• Sensitivity and specificity of the test in early detecting cancers

  12 months following enrolment

Secondary Outcomes (2)

• Positive predictive value of the test in determining the origin of tumour, as compared to the findings of the imaging diagnostic tests

  12 months following enrolment

• Rate of cancer development in the high-risk group as compared to the moderate-risk population

  12 months following enrolment

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will include both males and females, aged 40 or above, who have no history of cancer. These people present at the Outpatient Clinic of the study hospitals either for periodically follow-up visits for their chronic conditions or for health check-up.The eligible participants will have to satisfy all of the inclusion and exclusion criteria to be recruited into this study.

You may qualify if:

• Aged 40 or above at enrolment
• Neither clinical suspicion of cancer nor history of confirmed cancer has been reported
• Agree to be contacted at 6 months and 12 months following enrolment to collect information about general health status and progress of cancer (if possible)
• Provide written informed consent

You may not qualify if:

• History of cancer (cancer has either been confirmed or been treated within the past 3 years)
• History of blood transfusion or bone marrow transplantation within the past 3 years
• Does not agree to participate in study
• The subject has clinical manifestations of pregnant.

Sponsors & Collaborators

• Gene Solutions: lead
• Medical University of Ho Chi Minh City: collaborator
• Hanoi Medical University: collaborator
• Hanoi Oncology Hospital: collaborator
• Hue Central Hospital: collaborator
• Da Nang Oncology Hospital: collaborator
• Thong Nhat Dong Nai General Hospital: collaborator
• Dong Nai General Hospital: collaborator
• Van Hanh General Hospital: collaborator
• Can Tho Oncology Hospital: collaborator
• Medic Medical Center: collaborator
• Le Van Thinh Hospital: collaborator
• People's Hospital 115: collaborator
• Xuyen A Hospital: collaborator
• Medical Genetics Institute: collaborator

Study Sites (1)

Hanoi medical university

Hanoi, Vietnam

Location

Related Publications (64)

• Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.

  PMID: 33538338 BACKGROUND

• Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.

  PMID: 30207593 BACKGROUND

• Pham T, Bui L, Kim G, Hoang D, Tran T, Hoang M. Cancers in Vietnam-Burden and Control Efforts: A Narrative Scoping Review. Cancer Control. 2019 Jan-Dec;26(1):1073274819863802. doi: 10.1177/1073274819863802.

  PMID: 31319695 BACKGROUND

• Ahlquist DA. Universal cancer screening: revolutionary, rational, and realizable. NPJ Precis Oncol. 2018 Oct 29;2:23. doi: 10.1038/s41698-018-0066-x. eCollection 2018.

  PMID: 30393772 BACKGROUND

• Brenner H, Jansen L, Ulrich A, Chang-Claude J, Hoffmeister M. Survival of patients with symptom- and screening-detected colorectal cancer. Oncotarget. 2016 Jul 12;7(28):44695-44704. doi: 10.18632/oncotarget.9412.

  PMID: 27213584 BACKGROUND

• National Lung Screening Trial Research Team; Aberle DR, Adams AM, Berg CD, Black WC, Clapp JD, Fagerstrom RM, Gareen IF, Gatsonis C, Marcus PM, Sicks JD. Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med. 2011 Aug 4;365(5):395-409. doi: 10.1056/NEJMoa1102873. Epub 2011 Jun 29.

  PMID: 21714641 BACKGROUND

• Tabar L, Fagerberg G, Chen HH, Duffy SW, Smart CR, Gad A, Smith RA. Efficacy of breast cancer screening by age. New results from the Swedish Two-County Trial. Cancer. 1995 May 15;75(10):2507-17. doi: 10.1002/1097-0142(19950515)75:103.0.co;2-h.

  PMID: 7736395 BACKGROUND

• Cappell MS. The pathophysiology, clinical presentation, and diagnosis of colon cancer and adenomatous polyps. Med Clin North Am. 2005 Jan;89(1):1-42, vii. doi: 10.1016/j.mcna.2004.08.011.

  PMID: 15527807 BACKGROUND

• Vahabi M. Breast cancer screening methods: a review of the evidence. Health Care Women Int. 2003 Nov;24(9):773-93. doi: 10.1080/07399330390229957.

  PMID: 14742116 BACKGROUND

• Chen X, Gole J, Gore A, He Q, Lu M, Min J, Yuan Z, Yang X, Jiang Y, Zhang T, Suo C, Li X, Cheng L, Zhang Z, Niu H, Li Z, Xie Z, Shi H, Zhang X, Fan M, Wang X, Yang Y, Dang J, McConnell C, Zhang J, Wang J, Yu S, Ye W, Gao Y, Zhang K, Liu R, Jin L. Non-invasive early detection of cancer four years before conventional diagnosis using a blood test. Nat Commun. 2020 Jul 21;11(1):3475. doi: 10.1038/s41467-020-17316-z.

  PMID: 32694610 BACKGROUND

• Bradley SH, Kennedy MPT, Neal RD. Recognising Lung Cancer in Primary Care. Adv Ther. 2019 Jan;36(1):19-30. doi: 10.1007/s12325-018-0843-5. Epub 2018 Nov 29.

  PMID: 30499068 BACKGROUND

• Hubbell E, Clarke CA, Aravanis AM, Berg CD. Modeled Reductions in Late-stage Cancer with a Multi-Cancer Early Detection Test. Cancer Epidemiol Biomarkers Prev. 2021 Mar;30(3):460-468. doi: 10.1158/1055-9965.EPI-20-1134. Epub 2020 Dec 16.

  PMID: 33328254 BACKGROUND

• Simmons C, Milburn J. Impact of Low-Dose Computed Tomography on Computed Tomography Orders and Scan Length. Ochsner J. 2019 Winter;19(4):303-308. doi: 10.31486/toj.19.0008.

  PMID: 31903052 BACKGROUND

• Newton KF, Newman W, Hill J. Review of biomarkers in colorectal cancer. Colorectal Dis. 2012 Jan;14(1):3-17. doi: 10.1111/j.1463-1318.2010.02439.x.

  PMID: 21040359 BACKGROUND

• Locker GY, Hamilton S, Harris J, Jessup JM, Kemeny N, Macdonald JS, Somerfield MR, Hayes DF, Bast RC Jr; ASCO. ASCO 2006 update of recommendations for the use of tumor markers in gastrointestinal cancer. J Clin Oncol. 2006 Nov 20;24(33):5313-27. doi: 10.1200/JCO.2006.08.2644. Epub 2006 Oct 23.

  PMID: 17060676 BACKGROUND

• Hundt S, Haug U, Brenner H. Blood markers for early detection of colorectal cancer: a systematic review. Cancer Epidemiol Biomarkers Prev. 2007 Oct;16(10):1935-53. doi: 10.1158/1055-9965.EPI-06-0994.

  PMID: 17932341 BACKGROUND

• Hauptman N, Glavac D. Colorectal Cancer Blood-Based Biomarkers. Gastroenterol Res Pract. 2017;2017:2195361. doi: 10.1155/2017/2195361. Epub 2017 Sep 25.

  PMID: 29147109 BACKGROUND

• Church TR, Wandell M, Lofton-Day C, Mongin SJ, Burger M, Payne SR, Castanos-Velez E, Blumenstein BA, Rosch T, Osborn N, Snover D, Day RW, Ransohoff DF; PRESEPT Clinical Study Steering Committee, Investigators and Study Team. Prospective evaluation of methylated SEPT9 in plasma for detection of asymptomatic colorectal cancer. Gut. 2014 Feb;63(2):317-25. doi: 10.1136/gutjnl-2012-304149. Epub 2013 Feb 13.

  PMID: 23408352 BACKGROUND

• Clarke CA, Hubbell E, Ofman JJ. Multi-cancer early detection: A new paradigm for reducing cancer-specific and all-cause mortality. Cancer Cell. 2021 Apr 12;39(4):447-448. doi: 10.1016/j.ccell.2021.02.004. Epub 2021 Feb 18. No abstract available.

  PMID: 33606995 BACKGROUND

• Cristiano S, Leal A, Phallen J, Fiksel J, Adleff V, Bruhm DC, Jensen SO, Medina JE, Hruban C, White JR, Palsgrove DN, Niknafs N, Anagnostou V, Forde P, Naidoo J, Marrone K, Brahmer J, Woodward BD, Husain H, van Rooijen KL, Orntoft MW, Madsen AH, van de Velde CJH, Verheij M, Cats A, Punt CJA, Vink GR, van Grieken NCT, Koopman M, Fijneman RJA, Johansen JS, Nielsen HJ, Meijer GA, Andersen CL, Scharpf RB, Velculescu VE. Genome-wide cell-free DNA fragmentation in patients with cancer. Nature. 2019 Jun;570(7761):385-389. doi: 10.1038/s41586-019-1272-6. Epub 2019 May 29.

  PMID: 31142840 BACKGROUND

• Dawson SJ, Tsui DW, Murtaza M, Biggs H, Rueda OM, Chin SF, Dunning MJ, Gale D, Forshew T, Mahler-Araujo B, Rajan S, Humphray S, Becq J, Halsall D, Wallis M, Bentley D, Caldas C, Rosenfeld N. Analysis of circulating tumor DNA to monitor metastatic breast cancer. N Engl J Med. 2013 Mar 28;368(13):1199-209. doi: 10.1056/NEJMoa1213261. Epub 2013 Mar 13.

  PMID: 23484797 BACKGROUND

• Diehl F, Li M, Dressman D, He Y, Shen D, Szabo S, Diaz LA Jr, Goodman SN, David KA, Juhl H, Kinzler KW, Vogelstein B. Detection and quantification of mutations in the plasma of patients with colorectal tumors. Proc Natl Acad Sci U S A. 2005 Nov 8;102(45):16368-73. doi: 10.1073/pnas.0507904102. Epub 2005 Oct 28.

  PMID: 16258065 BACKGROUND

• Diehl F, Schmidt K, Choti MA, Romans K, Goodman S, Li M, Thornton K, Agrawal N, Sokoll L, Szabo SA, Kinzler KW, Vogelstein B, Diaz LA Jr. Circulating mutant DNA to assess tumor dynamics. Nat Med. 2008 Sep;14(9):985-90. doi: 10.1038/nm.1789. Epub 2007 Jul 31.

  PMID: 18670422 BACKGROUND

• Durham AL, Adcock IM. The relationship between COPD and lung cancer. Lung Cancer. 2015 Nov;90(2):121-7. doi: 10.1016/j.lungcan.2015.08.017. Epub 2015 Aug 29.

  PMID: 26363803 BACKGROUND

• Ferlay J, Colombet M, Soerjomataram I, Parkin DM, Pineros M, Znaor A, Bray F. Cancer statistics for the year 2020: An overview. Int J Cancer. 2021 Apr 5. doi: 10.1002/ijc.33588. Online ahead of print.

  PMID: 33818764 BACKGROUND

• Garcia-Murillas I, Schiavon G, Weigelt B, Ng C, Hrebien S, Cutts RJ, Cheang M, Osin P, Nerurkar A, Kozarewa I, Garrido JA, Dowsett M, Reis-Filho JS, Smith IE, Turner NC. Mutation tracking in circulating tumor DNA predicts relapse in early breast cancer. Sci Transl Med. 2015 Aug 26;7(302):302ra133. doi: 10.1126/scitranslmed.aab0021.

  PMID: 26311728 BACKGROUND

• Gerlinger M, Rowan AJ, Horswell S, Math M, Larkin J, Endesfelder D, Gronroos E, Martinez P, Matthews N, Stewart A, Tarpey P, Varela I, Phillimore B, Begum S, McDonald NQ, Butler A, Jones D, Raine K, Latimer C, Santos CR, Nohadani M, Eklund AC, Spencer-Dene B, Clark G, Pickering L, Stamp G, Gore M, Szallasi Z, Downward J, Futreal PA, Swanton C. Intratumor heterogeneity and branched evolution revealed by multiregion sequencing. N Engl J Med. 2012 Mar 8;366(10):883-892. doi: 10.1056/NEJMoa1113205.

  PMID: 22397650 BACKGROUND

• Colomer R, Ruibal A, Genolla J, Salvador L. Circulating CA 15-3 antigen levels in non-mammary malignancies. Br J Cancer. 1989 Feb;59(2):283-6. doi: 10.1038/bjc.1989.58.

  PMID: 2930693 BACKGROUND

• Duffy MJ. Serum tumor markers in breast cancer: are they of clinical value? Clin Chem. 2006 Mar;52(3):345-51. doi: 10.1373/clinchem.2005.059832. Epub 2006 Jan 12.

  PMID: 16410341 BACKGROUND

• Park BW, Oh JW, Kim JH, Park SH, Kim KS, Kim JH, Lee KS. Preoperative CA 15-3 and CEA serum levels as predictor for breast cancer outcomes. Ann Oncol. 2008 Apr;19(4):675-81. doi: 10.1093/annonc/mdm538. Epub 2007 Nov 23.

  PMID: 18037623 BACKGROUND

• Bray C, Bell LN, Liang H, Collins D, Yale SH. Colorectal Cancer Screening. WMJ. 2017 Feb;116(1):27-33.

  PMID: 29099566 BACKGROUND

• Jahr S, Hentze H, Englisch S, Hardt D, Fackelmayer FO, Hesch RD, Knippers R. DNA fragments in the blood plasma of cancer patients: quantitations and evidence for their origin from apoptotic and necrotic cells. Cancer Res. 2001 Feb 15;61(4):1659-65.

  PMID: 11245480 BACKGROUND

• Schwarzenbach H, Hoon DS, Pantel K. Cell-free nucleic acids as biomarkers in cancer patients. Nat Rev Cancer. 2011 Jun;11(6):426-37. doi: 10.1038/nrc3066. Epub 2011 May 12.

  PMID: 21562580 BACKGROUND

• Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer Statistics, 2021. CA Cancer J Clin. 2021 Jan;71(1):7-33. doi: 10.3322/caac.21654. Epub 2021 Jan 12.

  PMID: 33433946 BACKGROUND

• Jiang P, Chan CW, Chan KC, Cheng SH, Wong J, Wong VW, Wong GL, Chan SL, Mok TS, Chan HL, Lai PB, Chiu RW, Lo YM. Lengthening and shortening of plasma DNA in hepatocellular carcinoma patients. Proc Natl Acad Sci U S A. 2015 Mar 17;112(11):E1317-25. doi: 10.1073/pnas.1500076112. Epub 2015 Feb 2.

  PMID: 25646427 BACKGROUND

• Underhill HR, Kitzman JO, Hellwig S, Welker NC, Daza R, Baker DN, Gligorich KM, Rostomily RC, Bronner MP, Shendure J. Fragment Length of Circulating Tumor DNA. PLoS Genet. 2016 Jul 18;12(7):e1006162. doi: 10.1371/journal.pgen.1006162. eCollection 2016 Jul.

  PMID: 27428049 BACKGROUND

• Bettegowda C, Sausen M, Leary RJ, Kinde I, Wang Y, Agrawal N, Bartlett BR, Wang H, Luber B, Alani RM, Antonarakis ES, Azad NS, Bardelli A, Brem H, Cameron JL, Lee CC, Fecher LA, Gallia GL, Gibbs P, Le D, Giuntoli RL, Goggins M, Hogarty MD, Holdhoff M, Hong SM, Jiao Y, Juhl HH, Kim JJ, Siravegna G, Laheru DA, Lauricella C, Lim M, Lipson EJ, Marie SK, Netto GJ, Oliner KS, Olivi A, Olsson L, Riggins GJ, Sartore-Bianchi A, Schmidt K, Shih lM, Oba-Shinjo SM, Siena S, Theodorescu D, Tie J, Harkins TT, Veronese S, Wang TL, Weingart JD, Wolfgang CL, Wood LD, Xing D, Hruban RH, Wu J, Allen PJ, Schmidt CM, Choti MA, Velculescu VE, Kinzler KW, Vogelstein B, Papadopoulos N, Diaz LA Jr. Detection of circulating tumor DNA in early- and late-stage human malignancies. Sci Transl Med. 2014 Feb 19;6(224):224ra24. doi: 10.1126/scitranslmed.3007094.

  PMID: 24553385 BACKGROUND

• Johnson DA, Barclay RL, Mergener K, Weiss G, Konig T, Beck J, Potter NT. Plasma Septin9 versus fecal immunochemical testing for colorectal cancer screening: a prospective multicenter study. PLoS One. 2014 Jun 5;9(6):e98238. doi: 10.1371/journal.pone.0098238. eCollection 2014.

  PMID: 24901436 BACKGROUND

• Xu X, Hou Y, Yin X, Bao L, Tang A, Song L, Li F, Tsang S, Wu K, Wu H, He W, Zeng L, Xing M, Wu R, Jiang H, Liu X, Cao D, Guo G, Hu X, Gui Y, Li Z, Xie W, Sun X, Shi M, Cai Z, Wang B, Zhong M, Li J, Lu Z, Gu N, Zhang X, Goodman L, Bolund L, Wang J, Yang H, Kristiansen K, Dean M, Li Y, Wang J. Single-cell exome sequencing reveals single-nucleotide mutation characteristics of a kidney tumor. Cell. 2012 Mar 2;148(5):886-95. doi: 10.1016/j.cell.2012.02.025.

  PMID: 22385958 BACKGROUND

• Lipson EJ, Velculescu VE, Pritchard TS, Sausen M, Pardoll DM, Topalian SL, Diaz LA Jr. Circulating tumor DNA analysis as a real-time method for monitoring tumor burden in melanoma patients undergoing treatment with immune checkpoint blockade. J Immunother Cancer. 2014 Dec 16;2(1):42. doi: 10.1186/s40425-014-0042-0. eCollection 2014.

  PMID: 25516806 BACKGROUND

• Tie J, Kinde I, Wang Y, Wong HL, Roebert J, Christie M, Tacey M, Wong R, Singh M, Karapetis CS, Desai J, Tran B, Strausberg RL, Diaz LA Jr, Papadopoulos N, Kinzler KW, Vogelstein B, Gibbs P. Circulating tumor DNA as an early marker of therapeutic response in patients with metastatic colorectal cancer. Ann Oncol. 2015 Aug;26(8):1715-22. doi: 10.1093/annonc/mdv177. Epub 2015 Apr 7.

  PMID: 25851626 BACKGROUND

• Olsson E, Winter C, George A, Chen Y, Howlin J, Tang MH, Dahlgren M, Schulz R, Grabau D, van Westen D, Ferno M, Ingvar C, Rose C, Bendahl PO, Ryden L, Borg A, Gruvberger-Saal SK, Jernstrom H, Saal LH. Serial monitoring of circulating tumor DNA in patients with primary breast cancer for detection of occult metastatic disease. EMBO Mol Med. 2015 Aug;7(8):1034-47. doi: 10.15252/emmm.201404913.

  PMID: 25987569 BACKGROUND

• Newman AM, Bratman SV, To J, Wynne JF, Eclov NC, Modlin LA, Liu CL, Neal JW, Wakelee HA, Merritt RE, Shrager JB, Loo BW Jr, Alizadeh AA, Diehn M. An ultrasensitive method for quantitating circulating tumor DNA with broad patient coverage. Nat Med. 2014 May;20(5):548-54. doi: 10.1038/nm.3519. Epub 2014 Apr 6.

  PMID: 24705333 BACKGROUND

• Newman AM, Lovejoy AF, Klass DM, Kurtz DM, Chabon JJ, Scherer F, Stehr H, Liu CL, Bratman SV, Say C, Zhou L, Carter JN, West RB, Sledge GW, Shrager JB, Loo BW Jr, Neal JW, Wakelee HA, Diehn M, Alizadeh AA. Integrated digital error suppression for improved detection of circulating tumor DNA. Nat Biotechnol. 2016 May;34(5):547-555. doi: 10.1038/nbt.3520. Epub 2016 Mar 28.

  PMID: 27018799 BACKGROUND

• Torre LA, Bray F, Siegel RL, Ferlay J, Lortet-Tieulent J, Jemal A. Global cancer statistics, 2012. CA Cancer J Clin. 2015 Mar;65(2):87-108. doi: 10.3322/caac.21262. Epub 2015 Feb 4.

  PMID: 25651787 BACKGROUND

• Torre LA, Siegel RL, Jemal A. Lung Cancer Statistics. Adv Exp Med Biol. 2016;893:1-19. doi: 10.1007/978-3-319-24223-1_1.

  PMID: 26667336 BACKGROUND

• Zahnd WE, Eberth JM. Lung Cancer Screening Utilization: A Behavioral Risk Factor Surveillance System Analysis. Am J Prev Med. 2019 Aug;57(2):250-255. doi: 10.1016/j.amepre.2019.03.015. Epub 2019 Jun 24.

  PMID: 31248742 BACKGROUND

• Kim JJ, Burger EA, Regan C, Sy S. Screening for Cervical Cancer in Primary Care: A Decision Analysis for the US Preventive Services Task Force. JAMA. 2018 Aug 21;320(7):706-714. doi: 10.1001/jama.2017.19872.

  PMID: 30140882 BACKGROUND

• Lehman CD, Arao RF, Sprague BL, Lee JM, Buist DS, Kerlikowske K, Henderson LM, Onega T, Tosteson AN, Rauscher GH, Miglioretti DL. National Performance Benchmarks for Modern Screening Digital Mammography: Update from the Breast Cancer Surveillance Consortium. Radiology. 2017 Apr;283(1):49-58. doi: 10.1148/radiol.2016161174. Epub 2016 Dec 5.

  PMID: 27918707 BACKGROUND

• Pinsky PF, Gierada DS, Black W, Munden R, Nath H, Aberle D, Kazerooni E. Performance of Lung-RADS in the National Lung Screening Trial: a retrospective assessment. Ann Intern Med. 2015 Apr 7;162(7):485-91. doi: 10.7326/M14-2086.

  PMID: 25664444 BACKGROUND

• Ofman JJ, Fendrick AM, Raza A. Novel multicancer early detection technology-potential value to employers and the workforce. Am J Manag Care. 2020 Dec;26(10 Spec No.):SP363. doi: 10.37765/ajmc.2020.88567.

  PMID: 33395237 BACKGROUND

• Cohen JD, Li L, Wang Y, Thoburn C, Afsari B, Danilova L, Douville C, Javed AA, Wong F, Mattox A, Hruban RH, Wolfgang CL, Goggins MG, Dal Molin M, Wang TL, Roden R, Klein AP, Ptak J, Dobbyn L, Schaefer J, Silliman N, Popoli M, Vogelstein JT, Browne JD, Schoen RE, Brand RE, Tie J, Gibbs P, Wong HL, Mansfield AS, Jen J, Hanash SM, Falconi M, Allen PJ, Zhou S, Bettegowda C, Diaz LA Jr, Tomasetti C, Kinzler KW, Vogelstein B, Lennon AM, Papadopoulos N. Detection and localization of surgically resectable cancers with a multi-analyte blood test. Science. 2018 Feb 23;359(6378):926-930. doi: 10.1126/science.aar3247. Epub 2018 Jan 18.

  PMID: 29348365 BACKGROUND

• Liu MC. Transforming the landscape of early cancer detection using blood tests-Commentary on current methodologies and future prospects. Br J Cancer. 2021 Apr;124(9):1475-1477. doi: 10.1038/s41416-020-01223-7. Epub 2021 Feb 9.

  PMID: 33558712 BACKGROUND

• Mathios D, Johansen JS, Cristiano S, Medina JE, Phallen J, Larsen KR, Bruhm DC, Niknafs N, Ferreira L, Adleff V, Chiao JY, Leal A, Noe M, White JR, Arun AS, Hruban C, Annapragada AV, Jensen SO, Orntoft MW, Madsen AH, Carvalho B, de Wit M, Carey J, Dracopoli NC, Maddala T, Fang KC, Hartman AR, Forde PM, Anagnostou V, Brahmer JR, Fijneman RJA, Nielsen HJ, Meijer GA, Andersen CL, Mellemgaard A, Bojesen SE, Scharpf RB, Velculescu VE. Detection and characterization of lung cancer using cell-free DNA fragmentomes. Nat Commun. 2021 Aug 20;12(1):5060. doi: 10.1038/s41467-021-24994-w.

  PMID: 34417454 BACKGROUND

• Liu L, Toung JM, Jassowicz AF, Vijayaraghavan R, Kang H, Zhang R, Kruglyak KM, Huang HJ, Hinoue T, Shen H, Salathia NS, Hong DS, Naing A, Subbiah V, Piha-Paul SA, Bibikova M, Granger G, Barnes B, Shen R, Gutekunst K, Fu S, Tsimberidou AM, Lu C, Eng C, Moulder SL, Kopetz ES, Amaria RN, Meric-Bernstam F, Laird PW, Fan JB, Janku F. Targeted methylation sequencing of plasma cell-free DNA for cancer detection and classification. Ann Oncol. 2018 Jun 1;29(6):1445-1453. doi: 10.1093/annonc/mdy119.

  PMID: 29635542 BACKGROUND

• Liu MC, Oxnard GR, Klein EA, Swanton C, Seiden MV; CCGA Consortium. Sensitive and specific multi-cancer detection and localization using methylation signatures in cell-free DNA. Ann Oncol. 2020 Jun;31(6):745-759. doi: 10.1016/j.annonc.2020.02.011. Epub 2020 Mar 30.

  PMID: 33506766 BACKGROUND

• Dang AH, Tran VU, Tran TT, Thi Pham HA, Le DT, Nguyen L, Nguyen NV, Thi Nguyen TH, Nguyen CV, Le HT, Thi Nguyen ML, Le VT, Nguyen PH, Vo BT, Thi Dao HT, Nguyen LT, Van Nguyen TC, Bui QN, Nguyen LH, Nguyen NH, Thi Nguyen QT, Le TX, Do TT, Dinh KT, Do HN, Phan MD, Nguyen HN, Tran LS, Giang H. Actionable Mutation Profiles of Non-Small Cell Lung Cancer patients from Vietnamese population. Sci Rep. 2020 Feb 17;10(1):2707. doi: 10.1038/s41598-020-59744-3.

  PMID: 32066856 BACKGROUND

• Nguyen HN, Cao NT, Van Nguyen TC, Le KND, Nguyen DT, Nguyen QT, Nguyen TT, Van Nguyen C, Le HT, Nguyen MT, Nguyen TV, Tran VU, Luong BA, Le LGH, Ho QC, Pham HT, Vo BT, Nguyen LT, Dang AH, Nguyen SD, Do DM, Do TT, Hoang AV, Dinh KT, Phan MD, Giang H, Tran LS. Liquid biopsy uncovers distinct patterns of DNA methylation and copy number changes in NSCLC patients with different EGFR-TKI resistant mutations. Sci Rep. 2021 Aug 12;11(1):16436. doi: 10.1038/s41598-021-95985-6.

  PMID: 34385540 BACKGROUND

• Nguyen HT, Tran DH, Ngo QD, Pham HT, Tran TT, Tran VU, Pham TN, Le TK, Le NT, Nguyen NM, Vo BT, Nguyen LT, Nguyen TV, Bui QTN, Nguyen HN, Luong BA, Le LGH, Do DM, Do TT, Hoang AV, Dinh KT, Phan MD, Tran LS, Giang H, Nguyen HN. Evaluation of a Liquid Biopsy Protocol using Ultra-Deep Massive Parallel Sequencing for Detecting and Quantifying Circulation Tumor DNA in Colorectal Cancer Patients. Cancer Invest. 2020 Feb;38(2):85-93. doi: 10.1080/07357907.2020.1713350. Epub 2020 Jan 24.

  PMID: 31939681 BACKGROUND

• Tran LS, Nguyen QT, Nguyen CV, Tran VU, Nguyen TT, Le HT, Nguyen MT, Le VT, Pham LS, Vo BT, Dang AH, Nguyen LT, Nguyen TV, Pham HT, Tran TT, Nguyen LH, Nguyen TT, Nguyen KT, Vu YV, Nguyen NH, Bui VQ, Bui HH, Do TT, Lam NV, Truong Dinh K, Phan MD, Nguyen HN, Giang H. Ultra-Deep Massive Parallel Sequencing of Plasma Cell-Free DNA Enables Large-Scale Profiling of Driver Mutations in Vietnamese Patients With Advanced Non-Small Cell Lung Cancer. Front Oncol. 2020 Aug 4;10:1351. doi: 10.3389/fonc.2020.01351. eCollection 2020.

  PMID: 32850431 BACKGROUND

• Tran LS, Pham HT, Tran VU, Tran TT, Dang AH, Le DT, Nguyen SL, Nguyen NV, Nguyen TV, Vo BT, Dao HT, Nguyen NH, Tran TH, Nguyen CV, Pham PC, Dang-Mai AT, Dinh-Nguyen TK, Phan VH, Do TT, Truong Dinh K, Do HN, Phan MD, Giang H, Nguyen HN. Ultra-deep massively parallel sequencing with unique molecular identifier tagging achieves comparable performance to droplet digital PCR for detection and quantification of circulating tumor DNA from lung cancer patients. PLoS One. 2019 Dec 16;14(12):e0226193. doi: 10.1371/journal.pone.0226193. eCollection 2019.

  PMID: 31841547 BACKGROUND

• Lo YMD, Han DSC, Jiang P, Chiu RWK. Epigenetics, fragmentomics, and topology of cell-free DNA in liquid biopsies. Science. 2021 Apr 9;372(6538):eaaw3616. doi: 10.1126/science.aaw3616.

  PMID: 33833097 BACKGROUND

• US Preventive Services Task Force; Krist AH, Davidson KW, Mangione CM, Barry MJ, Cabana M, Caughey AB, Davis EM, Donahue KE, Doubeni CA, Kubik M, Landefeld CS, Li L, Ogedegbe G, Owens DK, Pbert L, Silverstein M, Stevermer J, Tseng CW, Wong JB. Screening for Lung Cancer: US Preventive Services Task Force Recommendation Statement. JAMA. 2021 Mar 9;325(10):962-970. doi: 10.1001/jama.2021.1117.

  PMID: 33687470 BACKGROUND

• Nguyen LHD, Nguyen THH, Le VH, Bui VQ, Nguyen LH, Pham NH, Phan TH, Nguyen HT, Tran VS, Bui CV, Vo VK, Nguyen PTN, Dang HHP, Pham VD, Cao VT, Phan NM, Tieu BL, Nguyen GTH, Vo DH, Tran TH, Nguyen TD, Nguyen VTC, Nguyen TH, Tran VU, Le MP, Tran TMT, Nguyen Nguyen M, Van TTV, Nguyen AN, Nguyen TT, Doan NNT, Nguyen HT, Doan PL, Huynh LAK, Nguyen TA, Nguyen HTP, Lu YT, Cao CTT, Nguyen VT, Le Quyen Le T, Luong TL, Doan TKP, Dao TT, Phan CD, Nguyen TX, Pham NT, Nguyen BT, Pham TTT, Le HL, Truong CT, Jasmine TX, Le MC, Phan VB, Truong QB, Tran THL, Huynh MT, Tran TQ, Nguyen ST, Tran V, Tran VK, Nguyen Nguyen H, Nguyen DS, Van Phan T, Do TT, Truong DK, Tang HS, Giang H, Nguyen HN, Phan MD, Tran LS. Prospective validation study: a non-invasive circulating tumor DNA-based assay for simultaneous early detection of multiple cancers in asymptomatic adults. BMC Med. 2025 Feb 14;23(1):90. doi: 10.1186/s12916-025-03929-y.

  PMID: 39948555 DERIVED

Related Links

• World Health Organization. Firm action is needed to eliminate viral hepatitis in Viet Nam. 2017
• World Health Organization. Vietnam: International Agency for Research on Cancer. 2021

Biospecimen

Retention: SAMPLES WITH DNA

Samples collected from the participants will be processed and analysed the ctDNA to detect cancer in the early stages and to predict the origin of the tumor. The residual blood of this test will be stored in -80 degree of Celcius for further testing to:- (i) screen or diagnose cancers; (ii) determine the hosts' genetic factors associated with the risks of cancers.

MeSH Terms

Conditions

Lung Neoplasms; Breast Neoplasms; Carcinoma, Hepatocellular; Colorectal Neoplasms; Stomach Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Liver Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Stomach Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2022
• First Posted: February 7, 2022
• Study Start: April 10, 2022
• Primary Completion: April 10, 2023
• Study Completion: April 10, 2024
• Last Updated: February 18, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

VN (1)