Clinical trial · Observational
Stomach Cancer Exosome-based Detection
Early Detection of Stomach Cancer With a Liquid Biopsy Based on Exosomal Micro-RNA
NCT06342427CI-TRIAL-00078624DESTINEXcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (19)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Adenocarcinoma | Gastric Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Gastric Cancer in Situ | — | UNRESOLVED | — |
| Gastric Cancer Metastatic to Liver | — | UNRESOLVED | — |
| Gastric Cancer Metastatic to Lung | — | UNRESOLVED | — |
| Gastric Cancer Stage | — | UNRESOLVED | — |
| Gastric Cancer, Stage 0 | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Gastric Cancer Stage I | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Gastric Cancer Stage IA | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Gastric Cancer Stage IB |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DESTINEX | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- label
- Patients with Gastric Cancer (Training)
- description
- Individuals with a pathologically confirmed diagnosis of gastric cancer
- interventionNames
- Diagnostic Test: DESTINEX
- label
- Patients without Gastric Cancer (Training)
- description
- Individuals without cancer at the time of blood sampling
- interventionNames
- Diagnostic Test: DESTINEX
- label
- Patients with Gastric Cancer (Validation)
- description
- Individuals with a pathologically confirmed diagnosis of gastric cancer
- interventionNames
- Diagnostic Test: DESTINEX
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. * Confirmed cancer-free status at the time of study inclusion (Non-disease controls). Exclusion Criteria: * Lack of written informed consent. * Systemic therapy before sampling. * Synchronous gastric and non-gastric cancer diagnosed at or before surgery.
References
Publications (24)
- BACKGROUNDSmyth 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
- BACKGROUNDSung 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
- BACKGROUNDNishiwada 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
- BACKGROUNDPasechnikov 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
- BACKGROUNDLee 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
- BACKGROUNDShimada 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
- 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.