AssesSment of Early-deteCtion basEd oN liquiD Biopsy in GASTRIC Cancer, ASCEND-Gastric

NCT05224596 | Unknown DMC

• 1 other identifier: B2020-390R
• Study Type: observational
• Target: 498
• Locations: 1 country
• Sites: 1

Brief Summary

ASCEND-Gastric is a prospective, multi-omics, observational study aimed at detecting gastric cancer by combined assays for serum protein markers, deep sequencing of cell-free DNA (cfDNA), circulating tumor DNA (ctDNA) mutation and circulating RNA. The study will enroll 498 participants, including 128 patients with benign gastric diseases and 370 patients with gastric cancer.

Conditions

Cancer

Keywords

Cancer; liquid biopsy; cell-free DNA (cfDNA) methylation; circulating tumor DNA (ctDNA) mutation; whole blood miRNA

Outcome Measures

Primary Outcomes (1)

• Sensitivity and specificity of the cfDNA methylation-based model in detecting gastric cancer.

  30 months

Secondary Outcomes (3)

• The differences of sensitivity and specificity in gastric cancer participants at different clinical stages.

  30 months

• Sensitivity and specificity for detecting gastric cancer of a cfDNA methylation-based model, in combination with other biomarkers.

  30 months

• Sensitivity and specificity of a ctDNA mutation-based model and a serum protein-based model in detecting gastric cancer, respectively.

  30 months

Other Outcomes (1)

• Sensitivity and specificity of a blood miRNA-based model in detecting gastric cancer.

  30 months

Study Arms (2)

Cancer arm

Baseline blood samples will be collected from new diagnosis cancer participants.

Diagnostic Test: Blood draw and blood-based biomarkers analyses

Benign disease arm

Baseline blood samples will be collected from new diagnosis benign gastric disease participants.

Diagnostic Test: Blood draw and blood-based biomarkers analyses

Interventions

Blood draw and blood-based biomarkers analyses DIAGNOSTIC_TEST

blood-based biomarkers analyses

Benign disease arm; Cancer arm

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Eligible participants in cancer arm will be recruited with new diagnosis of gastric cancer and without any types of tumor treatment. Eligible participants in benign disease arm will be recruited with new diagnosis of benign gastric disease and without any types of treatment.

You may qualify if:

• Age 40-75 years at the day of consenting to the study.
• Able to provide a written informed consent.
• No prior cancer treatment (local or systematic) with either of the following:
• A. Pathologically confirmed cancer diagnosis within 42 days prior to blood draw.
• B. High suspicious for cancer diagnosis by imaging tests or other routine clinical examinations, with confirmed pathological cancer diagnosis within 42 days after the blood draw.

You may not qualify if:

• Insufficient qualified blood samples.
• During pregnancy or lactation.
• Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant.
• Recipient of blood transfusion within 7 days prior to blood draw.
• Recipient of anti-tumor drugs to treat non-cancer diseases within 30 days prior to blood draw.
• With other known malignant tumors or multiple primary tumors.
• Age 40-75 years at the day of consenting to the study.
• Able to provide a written informed consent.
• Able to provide sufficient and qualified blood samples for study tests.
• Have either of the following:
• A. Pathological confirmed diagnosis of benign diseases within 90 days prior to the study blood draw, with no prior treatment such as surgical resection.
• B. High suspicious for benign diseases diagnosis by radiological or other routine clinical assessments, with confirmed benign diseases diagnosis within 42 days after study blood draw.
• Insufficient qualified blood sample for study test.
• During pregnancy or lactation.
• Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead
• Guangzhou Burning Rock Bioengineering Ltd.: collaborator

Study Sites (1)

ZhongShan hospital FuDan university

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Related Publications (30)

• 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

• Sano T, Coit DG, Kim HH, Roviello F, Kassab P, Wittekind C, Yamamoto Y, Ohashi Y. Proposal of a new stage grouping of gastric cancer for TNM classification: International Gastric Cancer Association staging project. Gastric Cancer. 2017 Mar;20(2):217-225. doi: 10.1007/s10120-016-0601-9. Epub 2016 Feb 20.

  PMID: 26897166 BACKGROUND

• So JBY, Kapoor R, Zhu F, Koh C, Zhou L, Zou R, Tang YC, Goo PCK, Rha SY, Chung HC, Yoong J, Yap CT, Rao J, Chia CK, Tsao S, Shabbir A, Lee J, Lam KP, Hartman M, Yong WP, Too HP, Yeoh KG. Development and validation of a serum microRNA biomarker panel for detecting gastric cancer in a high-risk population. Gut. 2021 May;70(5):829-837. doi: 10.1136/gutjnl-2020-322065. Epub 2020 Oct 7.

  PMID: 33028667 BACKGROUND

• Miki K. Gastric cancer screening using the serum pepsinogen test method. Gastric Cancer. 2006;9(4):245-53. doi: 10.1007/s10120-006-0397-0. Epub 2006 Nov 24.

  PMID: 17235625 BACKGROUND

• Li MY, Zhang DQ, Lu X, Chen WC. [Comparison of two serological methods in screening gastric cancer and its precancerous condition]. Zhonghua Nei Ke Za Zhi. 2018 Dec 1;57(12):907-911. doi: 10.3760/cma.j.issn.0578-1426.2018.12.006. Chinese.

  PMID: 30486559 BACKGROUND

• Hamashima C; Systematic Review Group and Guideline Development Group for Gastric Cancer Screening Guidelines. Update version of the Japanese Guidelines for Gastric Cancer Screening. Jpn J Clin Oncol. 2018 Jul 1;48(7):673-683. doi: 10.1093/jjco/hyy077.

  PMID: 29889263 BACKGROUND

• Choi KS, Jun JK, Park EC, Park S, Jung KW, Han MA, Choi IJ, Lee HY. Performance of different gastric cancer screening methods in Korea: a population-based study. PLoS One. 2012;7(11):e50041. doi: 10.1371/journal.pone.0050041. Epub 2012 Nov 29.

  PMID: 23209638 BACKGROUND

• Zhang X, Li M, Chen S, Hu J, Guo Q, Liu R, Zheng H, Jin Z, Yuan Y, Xi Y, Hua B. Endoscopic Screening in Asian Countries Is Associated With Reduced Gastric Cancer Mortality: A Meta-analysis and Systematic Review. Gastroenterology. 2018 Aug;155(2):347-354.e9. doi: 10.1053/j.gastro.2018.04.026. Epub 2018 Apr 30.

  PMID: 29723507 BACKGROUND

• Chen M, Zhao H. Next-generation sequencing in liquid biopsy: cancer screening and early detection. Hum Genomics. 2019 Aug 1;13(1):34. doi: 10.1186/s40246-019-0220-8.

  PMID: 31370908 BACKGROUND

• Kang HM, Kim GH, Jeon HK, Kim DH, Jeon TY, Park DY, Jeong H, Chun WJ, Kim MH, Park J, Lim M, Kim TH, Cho YK. Circulating tumor cells detected by lab-on-a-disc: Role in early diagnosis of gastric cancer. PLoS One. 2017 Jun 29;12(6):e0180251. doi: 10.1371/journal.pone.0180251. eCollection 2017.

  PMID: 28662130 BACKGROUND

• Haber DA, Velculescu VE. Blood-based analyses of cancer: circulating tumor cells and circulating tumor DNA. Cancer Discov. 2014 Jun;4(6):650-61. doi: 10.1158/2159-8290.CD-13-1014. Epub 2014 May 6.

  PMID: 24801577 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

• Cabel L, Decraene C, Bieche I, Pierga JY, Bennamoun M, Fuks D, Ferraz JM, Lefevre M, Baulande S, Bernard V, Vacher S, Mariani P, Proudhon C, Bidard FC, Louvet C. Limited Sensitivity of Circulating Tumor DNA Detection by Droplet Digital PCR in Non-Metastatic Operable Gastric Cancer Patients. Cancers (Basel). 2019 Mar 21;11(3):396. doi: 10.3390/cancers11030396.

  PMID: 30901876 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

• Abbosh C, Birkbak NJ, Wilson GA, Jamal-Hanjani M, Constantin T, Salari R, Le Quesne J, Moore DA, Veeriah S, Rosenthal R, Marafioti T, Kirkizlar E, Watkins TBK, McGranahan N, Ward S, Martinson L, Riley J, Fraioli F, Al Bakir M, Gronroos E, Zambrana F, Endozo R, Bi WL, Fennessy FM, Sponer N, Johnson D, Laycock J, Shafi S, Czyzewska-Khan J, Rowan A, Chambers T, Matthews N, Turajlic S, Hiley C, Lee SM, Forster MD, Ahmad T, Falzon M, Borg E, Lawrence D, Hayward M, Kolvekar S, Panagiotopoulos N, Janes SM, Thakrar R, Ahmed A, Blackhall F, Summers Y, Hafez D, Naik A, Ganguly A, Kareht S, Shah R, Joseph L, Marie Quinn A, Crosbie PA, Naidu B, Middleton G, Langman G, Trotter S, Nicolson M, Remmen H, Kerr K, Chetty M, Gomersall L, Fennell DA, Nakas A, Rathinam S, Anand G, Khan S, Russell P, Ezhil V, Ismail B, Irvin-Sellers M, Prakash V, Lester JF, Kornaszewska M, Attanoos R, Adams H, Davies H, Oukrif D, Akarca AU, Hartley JA, Lowe HL, Lock S, Iles N, Bell H, Ngai Y, Elgar G, Szallasi Z, Schwarz RF, Herrero J, Stewart A, Quezada SA, Peggs KS, Van Loo P, Dive C, Lin CJ, Rabinowitz M, Aerts HJWL, Hackshaw A, Shaw JA, Zimmermann BG; TRACERx consortium; PEACE consortium; Swanton C. Phylogenetic ctDNA analysis depicts early-stage lung cancer evolution. Nature. 2017 Apr 26;545(7655):446-451. doi: 10.1038/nature22364.

  PMID: 28445469 BACKGROUND

• Cree IA, Uttley L, Buckley Woods H, Kikuchi H, Reiman A, Harnan S, Whiteman BL, Philips ST, Messenger M, Cox A, Teare D, Sheils O, Shaw J; UK Early Cancer Detection Consortium. The evidence base for circulating tumour DNA blood-based biomarkers for the early detection of cancer: a systematic mapping review. BMC Cancer. 2017 Oct 23;17(1):697. doi: 10.1186/s12885-017-3693-7.

  PMID: 29061138 BACKGROUND

• Cohen JD, Javed AA, Thoburn C, Wong F, Tie J, Gibbs P, Schmidt CM, Yip-Schneider MT, Allen PJ, Schattner M, Brand RE, Singhi AD, Petersen GM, Hong SM, Kim SC, Falconi M, Doglioni C, Weiss MJ, Ahuja N, He J, Makary MA, Maitra A, Hanash SM, Dal Molin M, Wang Y, Li L, Ptak J, Dobbyn L, Schaefer J, Silliman N, Popoli M, Goggins MG, Hruban RH, Wolfgang CL, Klein AP, Tomasetti C, Papadopoulos N, Kinzler KW, Vogelstein B, Lennon AM. Combined circulating tumor DNA and protein biomarker-based liquid biopsy for the earlier detection of pancreatic cancers. Proc Natl Acad Sci U S A. 2017 Sep 19;114(38):10202-10207. doi: 10.1073/pnas.1704961114. Epub 2017 Sep 5.

  PMID: 28874546 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

• Klutstein M, Nejman D, Greenfield R, Cedar H. DNA Methylation in Cancer and Aging. Cancer Res. 2016 Jun 15;76(12):3446-50. doi: 10.1158/0008-5472.CAN-15-3278. Epub 2016 Jun 2.

  PMID: 27256564 BACKGROUND

• Meng H, Cao Y, Qin J, Song X, Zhang Q, Shi Y, Cao L. DNA methylation, its mediators and genome integrity. Int J Biol Sci. 2015 Apr 8;11(5):604-17. doi: 10.7150/ijbs.11218. eCollection 2015.

  PMID: 25892967 BACKGROUND

• Morgan AE, Davies TJ, Mc Auley MT. The role of DNA methylation in ageing and cancer. Proc Nutr Soc. 2018 Nov;77(4):412-422. doi: 10.1017/S0029665118000150. Epub 2018 Apr 30.

  PMID: 29708096 BACKGROUND

• Widschwendter M, Jones A, Evans I, Reisel D, Dillner J, Sundstrom K, Steyerberg EW, Vergouwe Y, Wegwarth O, Rebitschek FG, Siebert U, Sroczynski G, de Beaufort ID, Bolt I, Cibula D, Zikan M, Bjorge L, Colombo N, Harbeck N, Dudbridge F, Tasse AM, Knoppers BM, Joly Y, Teschendorff AE, Pashayan N; FORECEE (4C) Consortium. Epigenome-based cancer risk prediction: rationale, opportunities and challenges. Nat Rev Clin Oncol. 2018 May;15(5):292-309. doi: 10.1038/nrclinonc.2018.30. Epub 2018 Feb 27.

  PMID: 29485132 BACKGROUND

• Guo S, Diep D, Plongthongkum N, Fung HL, Zhang K, Zhang K. Identification of methylation haplotype blocks aids in deconvolution of heterogeneous tissue samples and tumor tissue-of-origin mapping from plasma DNA. Nat Genet. 2017 Apr;49(4):635-642. doi: 10.1038/ng.3805. Epub 2017 Mar 6.

  PMID: 28263317 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

• 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

• Hu W, Zheng W, Liu Q, Chu H, Chen S, Kim JJ, Wu J, Si J. Diagnostic accuracy of DNA methylation in detection of gastric cancer: a meta-analysis. Oncotarget. 2017 Nov 3;8(68):113142-113152. doi: 10.18632/oncotarget.22613. eCollection 2017 Dec 22.

  PMID: 29348893 BACKGROUND

• Anderson BW, Suh YS, Choi B, Lee HJ, Yab TC, Taylor WR, Dukek BA, Berger CK, Cao X, Foote PH, Devens ME, Boardman LA, Kisiel JB, Mahoney DW, Slettedahl SW, Allawi HT, Lidgard GP, Smyrk TC, Yang HK, Ahlquist DA. Detection of Gastric Cancer with Novel Methylated DNA Markers: Discovery, Tissue Validation, and Pilot Testing in Plasma. Clin Cancer Res. 2018 Nov 15;24(22):5724-5734. doi: 10.1158/1078-0432.CCR-17-3364. Epub 2018 May 29.

  PMID: 29844130 BACKGROUND

• Gao Y, Zhang K, Xi H, Cai A, Wu X, Cui J, Li J, Qiao Z, Wei B, Chen L. Diagnostic and prognostic value of circulating tumor DNA in gastric cancer: a meta-analysis. Oncotarget. 2017 Jan 24;8(4):6330-6340. doi: 10.18632/oncotarget.14064.

  PMID: 28009985 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

• 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

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Neoplasms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Yihong Sun Sun, MD

  Zhongshan Hospital, Fudan University,China

  PRINCIPAL INVESTIGATOR

• Xuefei Wang, MD

  Zhongshan Hospital, Fudan University,China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yihong Sun, MD

CONTACT

+86-021-65642662; sun.yihong@zs-hospital.sh.cn

Xuefei Wang, MD

CONTACT

+86-021-65642662; wang.xuefei@zs-hospital.sh.cn

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2022
• First Posted: February 4, 2022
• Study Start: January 18, 2021
• Primary Completion: May 30, 2022
• Study Completion: September 22, 2022
• Last Updated: February 28, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)