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
|Condition or disease||Intervention/treatment|
|Colon Cancer||Behavioral: Questionnaire|
Hide 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.
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|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|
Colon Cancer Patients
Patients with colon cancer recently removed by surgery.
Two questionnaires taking 30 minutes to complete.
Other Name: Survey
- 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.
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
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Cathy Eng, MD||M.D. Anderson Cancer Center|