Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-25 @ 3:26 AM
NCT ID:
NCT00354705
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
14 Years
Study:
NCT00354705
Study Brief:
Protocol Section:
NCT00354705