Clinical trial · Observational
Prognostic Molecular and Environmental Factors in High-Risk Colon Cancer Patients
Prognostic Molecular and Environmental Factors in High-Risk Stage II and Stage III Colon Cancer Patients
NCT00354705CI-TRIAL-00038548unknownClinicalTrials.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)
The goal of this research study is to identify biologic and lifestyle factors that may increase a person's risk of developing a recurrence (return) of colon cancer.
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 |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Questionnaire | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Colon Cancer Patients
- description
- Patients with colon cancer recently removed by surgery.
- interventionNames
- Behavioral: Questionnaire
Primary outcomes (1)
- measure
- Occurence of Recurrent Colon Cancer
- timeFrame
- Information collected at 1, 2 and 3 years after completion of adjuvant chemotherapy or at the time of reoccurrence.
- description
- Study endpoint is occurrence of recurrent colon carcinoma determined radiologically and/or histologically.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 14 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically proven adenocarcinoma of the colon. Those patients that do not have tissue available at MDACC for analysis will be eligible to participate in the blood, questionnaire and data portion of the study. They will not participate in the tissue portion of this study. 2. AJCC stage II \[T3-4(subscript)N0(subscript)M0(subscript)\]or stage III \[TX(subscript)N1-3(subscript)M0(subscript)\]. 3. Age \>= 14 yrs old. 4. If the patient elects to receive chemotherapy and it is to be administered outside of M. D. Anderson Cancer Center (MDACC), the patient must agree to complete all subsequent surveillance at M.D. Anderson Cancer Center if participating in this clinical trial. 5. Ability to understand and the willingness to sign the written informed consent/authorization document. Exclusion Criteria: 1. Patients who have initiated adjuvant chemotherapy prior to participating in this study will not be included. 2. Patients with known history of familial adenomatous polyposis (FAP), hereditary nonpolyposis colorectal cancer (HNPCC), and any other hereditary polyposis syndrome (Muir Torre, Gardner's Syndrome, etc) will be excluded since these patients are at increased risk for second primary malignancies and are at higher risk of recurrent disease. 3. No prior malignancies (excluding non-melanomatous skin neoplasms) over the past 5 years. 4. Patients with a known diagnosis of HIV/AIDS or Hepatitis C will be excluded from this study due to their increased risk of second primary malignancies that may complicate appropriate analysis of DFS. 5. Patients who are unable to self-administer the protocol questionnaire will be excluded from this study.
References
Publications (0)
Data not yet available
No reference posted for this study.