Clinical trial · Observational
Biomarker Analysis for Patients With Metastatic Colorectal Cancer (MCC)
Feasibility Study of Biomarker Analysis for Patients With Metastatic 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)
Patients are being asked to participate in this study who have colorectal cancer that has come back after initial treatment. The investigators want to improve treatment in patients with this disease. In other types of cancers, it has been possible to improve treatment by studying the gene mutations (called biomarkers) in a patient's cancer and "matching" these to existing cancer therapies or study drugs which target that specific mutation. Colorectal cancers have not been routinely tested in this way. In this study, investigators will determine whether mutational testing can be successfully done on colorectal cancers and how often mutations are detected for which there are existing drugs (or drugs in development). The results will be used to determine if treating physicians use this information in planning subsequent treatment.
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 |
|---|---|---|---|
| Advanced Metastatic Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Early recurrence (≤ 12 months)
- description
- Biospecimens from 25 patients who have had early recurrence (≤ 12 months) of their metastatic colorectal cancer
- label
- Late recurrence (> 12 months)
- description
- Biospecimens from 25 patients who have had late recurrence (\> 12 months) of their metastatic colorectal cancer
Primary outcomes (1)
- measure
- number of drug targetable genetic changes found in tumor tissue sample
- timeFrame
- 6 months
- description
- The frequencies and sites of 47 clinically relevant mutations or amplifications from biospecimens of early and/or late recurrence patients will be tabulated and summarized based on the evaluable population, respectively. The number of clinically actionable mutations with FDA-approved drugs will be compared to the number without and to those with associated clinical trials.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Has been re-staged to Stage IV colorectal cancer following recurrence after adjuvant chemo-therapy treatment for Stage II or III disease 2. Primary tumor has been resected prior to the patient being diagnosed with Stage IV disease 3. Able to submit archival tissue from the patient's resected primary tumor taken prior to diagnosis of metastatic disease 4. Tumor tissue (biopsy or surgery) was retrieved within 4 weeks from the date of signing the ICF and tested as outlined in the protocol: • FFPE specimen (blocks or cut slides) currently in storage at a pathology lab. Such tissue may be archival and stored, for no more than 5 years, being obtained at the time for a standard of care diagnostic or research biopsy. 5. Is at least 18 years old 6. Is willing to allow access to clinical and demographic information 7. Has signed a Patient Informed Consent Form 8. Has signed a Patient Authorization Form (HIPAA) Exclusion Criteria: 1. Is unable or unwilling to provide informed consent for collection and profiling of tumor tissue 2. PATIENT HAS NOT RECEIVED PRIOR ADJUVANT TREATMENT FOR STAGE II OR III COLORECTAL CANCER OR HAS BEEN ORIGINALLY DIAGNOSED WITH STAGE IV
References
Publications (1)
- BACKGROUNDde Gramont A, Hubbard J, Shi Q, O'Connell MJ, Buyse M, Benedetti J, Bot B, O'Callaghan C, Yothers G, Goldberg RM, Blanke CD, Benson A, Deng Q, Alberts SR, Andre T, Wolmark N, Grothey A, Sargent D. Association between disease-free survival and overall survival when survival is prolonged after recurrence in patients receiving cytotoxic adjuvant therapy for colon cancer: simulations based on the 20,800 patient ACCENT data set. J Clin Oncol. 2010 Jan 20;28(3):460-5. doi: 10.1200/JCO.2009.23.1407. Epub 2009 Dec 14. PMID 20008641