Clinical trial · Observational
Genetic Study of Young Patients With Colorectal Cancer
A Prospective Study Of The Prognostic Significance Of Microsatellite Instability In Patients With Early Age-Of-Onset 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)
RATIONALE: Identifying gene mutations (microsatellite instability) may allow doctors to plan effective treatment for patients who develop colorectal cancer at an early age. PURPOSE: Genetic trial to determine the significance of gene mutations in helping predict the outcome of treatment in patients who develop stage I, stage II, or stage III colorectal cancer at an early age.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| microsatellite instability analysis | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Group 1
- description
- Patients undergo baseline colonoscopy before or within 6 months of initial curative resection and then surveillance colonoscopy at 1, 3, and 5 years (+/- 6 months) after resection. The number, size, location, histology, and method of removal of polyps are documented at the time of colonoscopy. Patients also undergo microsatellite instability (MSI) status testing and complete family history questionnaires at baseline. The prognostic significance of family history and MSI status is evaluated. The individual histologic features of the tumors are compared with the MSI status to determine their predictive value. The histologic features are also correlated with outcome to determine their prognostic significance. Patients may be referred for genetic counseling.
- interventionNames
- Genetic: microsatellite instability analysis
Primary outcomes (1)
- measure
- overall survival
- timeFrame
- Up to 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 49 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of stage I-III adenocarcinoma of the colon or rectum * Must have undergone an initial curative resection within the past year * No colon or rectal cancer resection that does not allow for definitive T or N staging * No initial post-surgical surveillance colonoscopy prior to study entry * Must have a pathology specimen, with representative normal and tumor tissues, available for submission to the ACOSOG Central Specimen Bank prior to study entry * No personal or family history of familial adenomatous polyposis * No recurrent colorectal cancer PATIENT CHARACTERISTICS: Age * 18 to 49 at first diagnosis Other * Must be willing to provide a family cancer history to the study team and continue with follow-up colonoscopic surveillance * No other malignancy within the past 5 years except completely resected cervical cancer or nonmelanoma skin cancer * No evidence of recurrence of other prior malignancy PRIOR CONCURRENT THERAPY: Radiotherapy * No prior pelvic radiotherapy for rectal cancer * No concurrent preoperative pelvic radiotherapy for rectal cancer Surgery * See Disease Characteristics
References
Publications (0)
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