Prognostic Molecular and Environmental Factors in High-Risk Colon Cancer Patients

NCT00354705 | Unknown

• 1 other identifier: 2005-0383
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Colon Cancer

Keywords

Colon Cancer; Adenocarcinoma of the Colon; Cancer Recurrence; Survey; Chemotherapy; Surgery

Outcome Measures

Primary Outcomes (1)

• Occurence of Recurrent Colon Cancer

  Study endpoint is occurrence of recurrent colon carcinoma determined radiologically and/or histologically.

  Information collected at 1, 2 and 3 years after completion of adjuvant chemotherapy or at the time of reoccurrence.

Study Arms (1)

Colon Cancer Patients

Patients with colon cancer recently removed by surgery.

Behavioral: Questionnaire

Interventions

Questionnaire BEHAVIORAL

Two questionnaires taking 30 minutes to complete.

Also known as: Survey

Colon Cancer Patients

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients 14 years of age and up with colon cancer recently removed by surgery and receiving chemotherapy to try to prevent cancer from returning.

You may qualify if:

• 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.
• AJCC stage II \[T3-4(subscript)N0(subscript)M0(subscript)\]or stage III \[TX(subscript)N1-3(subscript)M0(subscript)\].
• Age \>= 14 yrs old.
• 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.
• Ability to understand and the willingness to sign the written informed consent/authorization document.

You may not qualify if:

• Patients who have initiated adjuvant chemotherapy prior to participating in this study will not be included.
• 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.
• No prior malignancies (excluding non-melanomatous skin neoplasms) over the past 5 years.
• 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.
• Patients who are unable to self-administer the protocol questionnaire will be excluded from this study.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

Biospecimen

Retention: SAMPLES WITH DNA

20 ml of blood for genomic analysis collected at baseline, at completion of adjuvant chemotherapy ( \<28 days after its completion) if applicable, at each subsequent surveillance visit (every 3 months after discontinuation of adjuvant chemotherapy, continuing for 2 years), and at time of disease recurrence, if applicable. 20 ml of blood for proteomic analysis studies collected at baseline, at completion of adjuvant chemotherapy, if applicable ( \<28 days after its completion), and at time of disease recurrence, if applicable. Tissue (0.2gm of tissue) from primary resection obtained at time of study enrollment. A tissue sample (0.2gm of tissue) also obtained, if possible, from patients that require surgical intervention at M.D. Anderson Cancer Center, for recurrent disease.

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Cathy Eng, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2006
• First Posted: July 20, 2006
• Study Start: January 1, 2006
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: May 10, 2019

Record last verified: 2019-05

Locations

US (1)