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

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.
 
ClinicalTrials.gov Identifier: NCT00354705
Recruitment Status : Active, not recruiting
First Posted : July 20, 2006
Last Update Posted : May 10, 2019
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.

Condition or disease Intervention/treatment
Colon Cancer Behavioral: Questionnaire

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Detailed Description:

Treatment with drugs (chemotherapy) and frequent evaluations by a doctor are standard practice to help prevent colon cancer from recurring after surgery. Despite these measures, the cancer does recur in a significant number of people, usually within the first 2-3 years from diagnosis.

In this study, researchers hope to identify genetic and environmental factors that may contribute to a person developing recurrent colon cancer. To help identify these factors, blood and tissue samples will be studied. You also will be asked to provide information about your background, lifestyle, and eating habits.

Participants able to take part in this study have had all of their known colon cancer removed by surgery and have agreed to receive chemotherapy to help prevent the cancer from recurring. Before you take part in this study, your medical information will be reviewed, and a performance status evaluation (how well you perform everyday activities) will be done. This will help the doctor decide if you are eligible to take part in the study.

If you are found to be eligible and you agree to take part in the study, you will be asked to fill out 2 questionnaires. One questionnaire asks about your background (age, education, etc.), work history, any exposure to toxic substances, medical history, smoking and alcohol history, family history of cancer, and your level of physical activity. The second questionnaire contains questions about what types of foods you eat, how often you eat them, whether you take vitamins and if so, what type(s). It will take about 30 minutes to fill out both of these questionnaires.

If your surgery to remove your colon cancer was not performed at MD Anderson, you will not be asked to participate in the tissue portion of this study described below but you will be asked to participate in the blood sample analysis and the study evaluations and questionnaire portion of this study every 3 months for a maximum of 2 years (starting from the beginning of the follow-up period, once all treatment is complete) or until your disease returns, which ever occurs first.

If your surgery was performed at MD Anderson Cancer Center, the samples of your cancer tissue will be analyzed, looking for any biologic factors related to colon cancer. Blood samples (about 4 teaspoons) for gene analysis (looking for any biologic factors associated with colon cancer) will also be collected.

Once follow-up begins, you will have study evaluations at MD Anderson every 3 months for 2 years or until your disease returns, which ever occurs first. Blood samples (about 4 teaspoons) for gene analysis will be collected within 14 days of completion of chemotherapy, and then every 3 months for 2 years after you enroll in this study. If your colon cancer recurs, a blood sample will be taken at that time also.

You will be asked to fill out the 2 questionnaires described above at the completion of your chemotherapy treatment (if applicable) and 1 and 2 years after your follow-up begins. If your colon cancer recurs, you will be asked to fill out the questionnaires at that time.

If you require surgery for cancer after enrolling in this study, a sample of leftover tissue will be collected for genetic analysis if the surgery is performed at MD Anderson Cancer Center.

You will not be informed of any results of the analysis of your blood and tumor samples or the questionnaires, as this research is exploratory. Your participation in this study will end if your disease returns or 2 years after you begin, whichever occurs first.

This is an investigational study. Taking part in this study requires that you return frequently to MD Anderson. Up to 200 participants will take part in this study. All will be enrolled at MD Anderson.


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Study Type : Observational
Estimated Enrollment : 200 participants
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
Actual Study Start Date : January 2006
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Group/Cohort Intervention/treatment
Colon Cancer Patients
Patients with colon cancer recently removed by surgery.
Behavioral: Questionnaire
Two questionnaires taking 30 minutes to complete.
Other Name: Survey




Primary Outcome Measures :
  1. 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.



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.


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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
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.

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

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00354705     History of Changes
Other Study ID Numbers: 2005-0383
First Posted: July 20, 2006    Key Record Dates
Last Update Posted: May 10, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by M.D. Anderson Cancer Center:
Colon Cancer
Adenocarcinoma of the Colon
Cancer Recurrence
Survey
Chemotherapy
Surgery
Additional relevant MeSH terms:
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Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases