Stomach Cancer Exosome-based Detection

NCT06342427 | Completed

• 1 other identifier: 23228/DESTINEX
• Study Type: observational
• Target: 809
• Locations: 2 countries
• Sites: 3

Brief Summary

Gastric cancer continues to have a poor prognosis primarily due to the inability to detect it in its early stages. This study will develop and validate a blood assay to facilitate the non-invasive detection of gastric cancer.

Conditions

Gastric Cancer; Gastric Adenocarcinoma; Gastric Cancer Stage; Gastric Neoplasm; Gastric Lesion; Gastric Cancer in Situ; Gastric Cancer Stage IV; Gastric Cancer Stage IIIB; Gastric Cancer Stage III; Gastric Cancer Stage IB; Gastric Cancer Stage IA; Gastric Cancer, Stage 0; Gastric Cancer Stage IIIA; Gastric Cancer Stage II; Gastric Cancer TNM Staging; Gastric Cancer Metastatic to Lung; Gastric Cancer Metastatic to Liver; Gastric Cancer Stage I; Gastric Cancer TNM Staging Primary Tumor (T) T2B

Outcome Measures

Primary Outcomes (1)

• Sensitivity

  True positive rate: the probability of a positive test result, conditioned on the individual truly being positive

  Through study completion, an average of 1 year

Secondary Outcomes (2)

• Specificity

  Through study completion, an average of 1 year

• Proportion of correct predictions (true positives and true negatives) among the total cases (i.e., accuracy)

  Through study completion, an average of 1 year

Study Arms (4)

Patients with Gastric Cancer (Training)

Individuals with a pathologically confirmed diagnosis of gastric cancer

Diagnostic Test: DESTINEX

Patients without Gastric Cancer (Training)

Individuals without cancer at the time of blood sampling

Diagnostic Test: DESTINEX

Patients with Gastric Cancer (Validation)

Individuals with a pathologically confirmed diagnosis of gastric cancer

Diagnostic Test: DESTINEX

Patients without Gastric Cancer (Validation)

Individuals without cancer at the time of blood sampling

Diagnostic Test: DESTINEX

Interventions

DESTINEX DIAGNOSTIC_TEST

A panel of microRNA, whose expression level is tested in serum samples.

Also known as: DESTINEX (DEtection of STomach NEoplasia in circulating eXosomes)

Patients with Gastric Cancer (Training); Patients with Gastric Cancer (Validation); Patients without Gastric Cancer (Training); Patients without Gastric Cancer (Validation)

Eligibility Criteria

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

Study Population

Two cohorts of individuals with and without gastric cancer (cases and controls, respectively)

You may qualify if:

• Histological diagnosis of stage I, II, III, IV gastric cancer (TNM classification, 8th edition) (cases).
• Received standard diagnostic and staging procedures as per local guidelines, and at least one sample was drawn before receiving any curative-intent treatment.

You may not qualify if:

• Lack of written informed consent.
• Systemic therapy before sampling.
• Synchronous gastric and non-gastric cancer diagnosed at or before surgery.

Sponsors & Collaborators

• City of Hope Medical Center: lead

Study Sites (3)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

Nagoya University

Nagoya, Japan

Location

Mie University

Tsu, Japan

Location

Related Publications (24)

• Smyth EC, Nilsson M, Grabsch HI, van Grieken NC, Lordick F. Gastric cancer. Lancet. 2020 Aug 29;396(10251):635-648. doi: 10.1016/S0140-6736(20)31288-5.

  PMID: 32861308 BACKGROUND

• 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

• Nishiwada S, Cui Y, Sho M, Jun E, Akahori T, Nakamura K, Sonohara F, Yamada S, Fujii T, Han IW, Tsai S, Kodera Y, Park JO, Von Hoff D, Kim SC, Li W, Goel A. Transcriptomic Profiling Identifies an Exosomal microRNA Signature for Predicting Recurrence Following Surgery in Patients With Pancreatic Ductal Adenocarcinoma. Ann Surg. 2022 Dec 1;276(6):e876-e885. doi: 10.1097/SLA.0000000000004993. Epub 2021 Jun 16.

  PMID: 34132691 BACKGROUND

• Pasechnikov V, Chukov S, Fedorov E, Kikuste I, Leja M. Gastric cancer: prevention, screening and early diagnosis. World J Gastroenterol. 2014 Oct 14;20(38):13842-62. doi: 10.3748/wjg.v20.i38.13842.

  PMID: 25320521 BACKGROUND

• Lee JH, Kim JG, Jung HK, Kim JH, Jeong WK, Jeon TJ, Kim JM, Kim YI, Ryu KW, Kong SH, Kim HI, Jung HY, Kim YS, Zang DY, Cho JY, Park JO, Lim DH, Jung ES, Ahn HS, Kim HJ. Clinical practice guidelines for gastric cancer in Korea: an evidence-based approach. J Gastric Cancer. 2014 Jun;14(2):87-104. doi: 10.5230/jgc.2014.14.2.87. Epub 2014 Jun 30.

  PMID: 25061536 BACKGROUND

• Shimada H, Noie T, Ohashi M, Oba K, Takahashi Y. Clinical significance of serum tumor markers for gastric cancer: a systematic review of literature by the Task Force of the Japanese Gastric Cancer Association. Gastric Cancer. 2014 Jan;17(1):26-33. doi: 10.1007/s10120-013-0259-5. Epub 2013 Apr 10.

  PMID: 23572188 BACKGROUND

• Heitzer E, Haque IS, Roberts CES, Speicher MR. Current and future perspectives of liquid biopsies in genomics-driven oncology. Nat Rev Genet. 2019 Feb;20(2):71-88. doi: 10.1038/s41576-018-0071-5.

  PMID: 30410101 BACKGROUND

• Siravegna G, Mussolin B, Venesio T, Marsoni S, Seoane J, Dive C, Papadopoulos N, Kopetz S, Corcoran RB, Siu LL, Bardelli A. How liquid biopsies can change clinical practice in oncology. Ann Oncol. 2019 Oct 1;30(10):1580-1590. doi: 10.1093/annonc/mdz227.

  PMID: 31373349 BACKGROUND

• Jung G, Hernandez-Illan E, Moreira L, Balaguer F, Goel A. Epigenetics of colorectal cancer: biomarker and therapeutic potential. Nat Rev Gastroenterol Hepatol. 2020 Feb;17(2):111-130. doi: 10.1038/s41575-019-0230-y. Epub 2020 Jan 3.

  PMID: 31900466 BACKGROUND

• Rupaimoole R, Slack FJ. MicroRNA therapeutics: towards a new era for the management of cancer and other diseases. Nat Rev Drug Discov. 2017 Mar;16(3):203-222. doi: 10.1038/nrd.2016.246. Epub 2017 Feb 17.

  PMID: 28209991 BACKGROUND

• Schwarzenbach H, Nishida N, Calin GA, Pantel K. Clinical relevance of circulating cell-free microRNAs in cancer. Nat Rev Clin Oncol. 2014 Mar;11(3):145-56. doi: 10.1038/nrclinonc.2014.5. Epub 2014 Feb 4.

  PMID: 24492836 BACKGROUND

• Shigeyasu K, Toden S, Zumwalt TJ, Okugawa Y, Goel A. Emerging Role of MicroRNAs as Liquid Biopsy Biomarkers in Gastrointestinal Cancers. Clin Cancer Res. 2017 May 15;23(10):2391-2399. doi: 10.1158/1078-0432.CCR-16-1676. Epub 2017 Jan 31.

  PMID: 28143873 BACKGROUND

• Toiyama Y, Okugawa Y, Goel A. DNA methylation and microRNA biomarkers for noninvasive detection of gastric and colorectal cancer. Biochem Biophys Res Commun. 2014 Dec 5;455(1-2):43-57. doi: 10.1016/j.bbrc.2014.08.001. Epub 2014 Aug 13.

  PMID: 25128828 BACKGROUND

• Okugawa Y, Grady WM, Goel A. Epigenetic Alterations in Colorectal Cancer: Emerging Biomarkers. Gastroenterology. 2015 Oct;149(5):1204-1225.e12. doi: 10.1053/j.gastro.2015.07.011. Epub 2015 Jul 26.

  PMID: 26216839 BACKGROUND

• Nik Mohamed Kamal NNSB, Shahidan WNS. Non-Exosomal and Exosomal Circulatory MicroRNAs: Which Are More Valid as Biomarkers? Front Pharmacol. 2020 Jan 20;10:1500. doi: 10.3389/fphar.2019.01500. eCollection 2019.

  PMID: 32038230 BACKGROUND

• Lopez K, Lai SWT, Lopez Gonzalez EJ, Davila RG, Shuck SC. Extracellular vesicles: A dive into their role in the tumor microenvironment and cancer progression. Front Cell Dev Biol. 2023 Mar 21;11:1154576. doi: 10.3389/fcell.2023.1154576. eCollection 2023.

  PMID: 37025182 BACKGROUND

• Zhu L, Li J, Gong Y, Wu Q, Tan S, Sun D, Xu X, Zuo Y, Zhao Y, Wei YQ, Wei XW, Peng Y. Exosomal tRNA-derived small RNA as a promising biomarker for cancer diagnosis. Mol Cancer. 2019 Apr 2;18(1):74. doi: 10.1186/s12943-019-1000-8.

  PMID: 30940133 BACKGROUND

• Miyazaki K, Wada Y, Okuno K, Murano T, Morine Y, Ikemoto T, Saito Y, Ikematsu H, Kinugasa Y, Shimada M, Goel A. An exosome-based liquid biopsy signature for pre-operative identification of lymph node metastasis in patients with pathological high-risk T1 colorectal cancer. Mol Cancer. 2023 Jan 6;22(1):2. doi: 10.1186/s12943-022-01685-8.

  PMID: 36609320 BACKGROUND

• Lane JS, Hoff DV, Cridebring D, Goel A. Extracellular Vesicles in Diagnosis and Treatment of Pancreatic Cancer: Current State and Future Perspectives. Cancers (Basel). 2020 Jun 10;12(6):1530. doi: 10.3390/cancers12061530.

  PMID: 32532129 BACKGROUND

• Lennon KM, Wakefield DL, Maddox AL, Brehove MS, Willner AN, Garcia-Mansfield K, Meechoovet B, Reiman R, Hutchins E, Miller MM, Goel A, Pirrotte P, Van Keuren-Jensen K, Jovanovic-Talisman T. Single molecule characterization of individual extracellular vesicles from pancreatic cancer. J Extracell Vesicles. 2019 Nov 4;8(1):1685634. doi: 10.1080/20013078.2019.1685634. eCollection 2019.

  PMID: 31741725 BACKGROUND

• Akers JC, Gonda D, Kim R, Carter BS, Chen CC. Biogenesis of extracellular vesicles (EV): exosomes, microvesicles, retrovirus-like vesicles, and apoptotic bodies. J Neurooncol. 2013 May;113(1):1-11. doi: 10.1007/s11060-013-1084-8. Epub 2013 Mar 2.

  PMID: 23456661 BACKGROUND

• Chaput N, Thery C. Exosomes: immune properties and potential clinical implementations. Semin Immunopathol. 2011 Sep;33(5):419-40. doi: 10.1007/s00281-010-0233-9. Epub 2010 Dec 21.

  PMID: 21174094 BACKGROUND

• Nakamura K, Zhu Z, Roy S, Jun E, Han H, Munoz RM, Nishiwada S, Sharma G, Cridebring D, Zenhausern F, Kim S, Roe DJ, Darabi S, Han IW, Evans DB, Yamada S, Demeure MJ, Becerra C, Celinski SA, Borazanci E, Tsai S, Kodera Y, Park JO, Bolton JS, Wang X, Kim SC, Von Hoff D, Goel A. An Exosome-based Transcriptomic Signature for Noninvasive, Early Detection of Patients With Pancreatic Ductal Adenocarcinoma: A Multicenter Cohort Study. Gastroenterology. 2022 Nov;163(5):1252-1266.e2. doi: 10.1053/j.gastro.2022.06.090. Epub 2022 Jul 16.

  PMID: 35850192 BACKGROUND

• Li A, Yu J, Kim H, Wolfgang CL, Canto MI, Hruban RH, Goggins M. MicroRNA array analysis finds elevated serum miR-1290 accurately distinguishes patients with low-stage pancreatic cancer from healthy and disease controls. Clin Cancer Res. 2013 Jul 1;19(13):3600-10. doi: 10.1158/1078-0432.CCR-12-3092. Epub 2013 May 22.

  PMID: 23697990 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Formalin-fixed and paraffin-embedded tissue samples Serum

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Ajay Goel, PhD

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 26, 2024
• First Posted: April 2, 2024
• Study Start: March 15, 2023
• Primary Completion: June 15, 2024
• Study Completion: June 15, 2024
• Last Updated: July 8, 2024

Record last verified: 2024-07

Locations

US (1); JP (2)