Clinical trial · Observational
Exosome-based Detection of Molecular Residual Disease in Stage II-III Colorectal Cancer
An Exosome-Based Liquid Biopsy Assay to Detect Molecular Residual Disease for the Identification of High-Risk Patients With Stage II-III Colorectal Cancer
- 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)
This study aims to establish an exosome-based liquid biopsy signature to detect molecular residual disease (MRD) in stage II-III colorectal cancer (CRC) patients. Identifying patients with MRD after surgery is crucial for selecting appropriate candidates for adjuvant chemotherapy (ACT), allowing for more personalized treatment approaches and potentially improving patient outcomes.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colo-rectal Cancer | — | UNRESOLVED | — |
| Colorectal Cancer Recurrent | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (4)
- label
- Training Cohort (Recurrence Group)
- description
- Stage II-III CRC patients who experienced postoperative recurrence (evaluated by miRNA panel).
- label
- Training Cohort (Non-Recurrence Group)
- description
- Stage II-III CRC patients who did not experience postoperative recurrence (evaluated by miRNA panel).
- label
- Testing Cohort (Recurrence Group)
- description
- Validation of miRNA panel and EMRATI score in independent stage II-III CRC patients who experienced postoperative recurrence.
- label
- Testing Cohort (Non-Recurrence Group)
- description
- Validation of miRNA panel and EMRATI score in independent stage II-III CRC patients who did not experience postoperative recurrence.
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with pathologically confirmed stage II or III colorectal cancer. 2. Patients who have undergone curative-intent surgery. 3. Patients with no evidence of distant metastasis (stage IV). 4. Patients aged 18 years or older. 5. Patients who provided written informed consent. Exclusion Criteria: 1. Patients with stage IV cancer or those receiving neoadjuvant therapy. 2. Patients with non-curative resection or requiring urgent surgery. 3. Patients with a follow-up period of fewer than 3 years. 4. Patients with severe comorbidities or who are unable to participate in follow-up assessments.
References
Publications (11)
- BACKGROUNDZhou H, Zhu L, Song J, Wang G, Li P, Li W, Luo P, Sun X, Wu J, Liu Y, Zhu S, Zhang Y. Liquid biopsy at the frontier of detection, prognosis and progression monitoring in colorectal cancer. Mol Cancer. 2022 Mar 25;21(1):86. doi: 10.1186/s12943-022-01556-2. PMID 35337361
- BACKGROUNDRuiz-Banobre J, Roy R, Alustiza Fernandez M, Murcia O, Jover R, Pera M, Balaguer F, Lopez-Lopez R, Goel A. Clinical significance of a microRNA signature for the identification and predicting prognosis in colorectal cancers with mucinous differentiation. Carcinogenesis. 2020 Nov 13;41(11):1498-1506. doi: 10.1093/carcin/bgaa097. PMID 32911537
- BACKGROUNDMatsuyama T, Toiyama Y, Ishikawa T, Okugawa Y, Yasuno M, Maurel J, Kinugasa Y, Uetake H, Goel A. A metastasis-associated microRNA-based liquid biopsy signature for risk-stratification in colorectal cancer: a multicenter cohort study. Clin Transl Med. 2022 Dec;12(12):e998. doi: 10.1002/ctm2.998. No abstract available. PMID 36513881
- BACKGROUNDMiyazaki 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
- BACKGROUNDMo S, Ye L, Wang D, Han L, Zhou S, Wang H, Dai W, Wang Y, Luo W, Wang R, Xu Y, Cai S, Liu R, Wang Z, Cai G. Early Detection of Molecular Residual Disease and Risk Stratification for Stage I to III Colorectal Cancer via Circulating Tumor DNA Methylation. JAMA Oncol. 2023 Jun 1;9(6):770-778. doi: 10.1001/jamaoncol.2023.0425. PMID 37079312
- BACKGROUNDYoshino T, Argiles G, Oki E, Martinelli E, Taniguchi H, Arnold D, Mishima S, Li Y, Smruti BK, Ahn JB, Faud I, Chee CE, Yeh KH, Lin PC, Chua C, Hasbullah HH, Lee MA, Sharma A, Sun Y, Curigliano G, Bando H, Lordick F, Yamanaka T, Tabernero J, Baba E, Cervantes A, Ohtsu A, Peters S, Ishioka C, Pentheroudakis G. Pan-Asian adapted ESMO Clinical Practice Guidelines for the diagnosis treatment and follow-up of patients with localised colon cancer. Ann Oncol. 2021 Dec;32(12):1496-1510. doi: 10.1016/j.annonc.2021.08.1752. Epub 2021 Aug 16.