Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00354705
Status:
UNKNOWN
Last Update Posted:
2019-05-10
First Post:
2006-07-18
Brief Title:
Prognostic Molecular and Environmental Factors in High-Risk Colon Cancer Patients
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Prognostic Molecular and Environmental Factors in High-Risk Stage II and Stage III Colon Cancer Patients
Status:
UNKNOWN
Status Verified Date:
2019-05
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this research study is to identify biologic and lifestyle factors that may increase a persons risk of developing a recurrence return of colon cancer
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 types 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
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 types 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None