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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00354705
First Posted: July 20, 2006
Last Update Posted: October 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
  Purpose
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.

Condition Intervention
Colon Cancer Behavioral: Questionnaire

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prognostic Molecular and Environmental Factors in High-Risk Stage II and Stage III Colon Cancer Patients

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Occurence of Recurrent Colon Cancer [ Time Frame: Information collected at 1, 2 and 3 years after completion of adjuvant chemotherapy or at the time of reoccurrence. ]
    Study endpoint is occurrence of recurrent colon carcinoma determined radiologically and/or histologically.


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.


Estimated Enrollment: 200
Actual Study Start Date: January 2006
Estimated Study Completion Date: January 2020
Estimated Primary Completion Date: January 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Colon Cancer Patients
Patients with colon cancer recently removed by surgery.
Behavioral: Questionnaire
Two questionnaires taking 30 minutes to complete.
Other Name: Survey

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   14 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00354705


Locations
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Cathy Eng, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00354705     History of Changes
Other Study ID Numbers: 2005-0383
First Submitted: July 18, 2006
First Posted: July 20, 2006
Last Update Posted: October 2, 2017
Last Verified: September 2017

Keywords provided by M.D. Anderson Cancer Center:
Colon Cancer
Adenocarcinoma of the Colon
Cancer Recurrence
Survey
Chemotherapy
Surgery

Additional relevant MeSH terms:
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases