Trial record 1 of 904 for:
colon cancer | Open Studies
Prognostic Molecular and Environmental Factors in High-Risk Colon Cancer Patients
This study is currently recruiting participants.
Verified May 2013 by M.D. Anderson Cancer Center
Sponsor:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00354705
First received: July 18, 2006
Last updated: May 6, 2013
Last verified: May 2013
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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 |
Resource links provided by NLM:
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. ] [ Designated as safety issue: No ]
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 |
| Study Start Date: | January 2006 |
| Estimated Primary Completion Date: | January 2015 (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| Ages Eligible for Study: | 14 Years and older |
| Genders Eligible for Study: | Both |
| 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:
- 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.
- All patients who participate in this study must agree to receive adjuvant chemotherapy. If the chemotherapy is to be administered outside M. D. Anderson Cancer Center, 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.
Exclusion Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00354705
Contacts
| Contact: Cathy Eng, MD | 713-792-2828 |
Locations
| United States, Texas | |
| UT MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: Cathy Eng, MD | |
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
| Principal Investigator: | Cathy Eng, MD | M.D. Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00354705 History of Changes |
| Other Study ID Numbers: | 2005-0383 |
| Study First Received: | July 18, 2006 |
| Last Updated: | May 6, 2013 |
| Health Authority: | United States: Institutional Review Board |
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 Colonic Diseases Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases |
ClinicalTrials.gov processed this record on June 18, 2013