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

Sponsored by:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00354705

Purpose

The purpose of this study is to identify genetic determinants and environmental factors that will help identify patients who are prone to develop recurrent colon cancer following surgical resection of high-risk American Joint Committee on Cancer (AJCC) stage II (T3-4N0M0) patients and stage III (TxN1-3M0) colon carcinoma despite the use of adjuvant chemotherapy and physician surveillance.

Primary Objectives:

To assess, in a preliminary manner, whether genetic polymorphisms may aid in the identification of patients in developing recurrent colon cancer.
To assess, in a preliminary manner, whether environmental influences may predispose patients to develop recurrent colon cancer.
To obtain and bank American Joint Committee on Cancer (AJCC) stage II/III surgical colon cancer specimens from study participants for tissue proteomics analysis.

Secondary Objectives:

To assess, in a preliminary manner, the impact of genomics and tissue proteomics on patient survival and outcome.
To assess tissue proteomics analysis of the primary tumor site versus that of surgically dissected lymph nodes.
To assess tissue proteomics of adjacent malignant and non-malignant lymph nodes.
To prospectively obtain tissue at time of disease recurrence for proteomics analysis.
To prospectively collect serum for proteomic analysis prior to, at the conclusion of adjuvant chemotherapy, and, if appropriate, at time of disease recurrence for validation of tissue proteomics analysis.

Condition	Intervention
Colon Cancer	Behavioral: Questionnaire

MedlinePlus related topics: Cancer

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, 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:

To identify biologic and lifestyle factors that may increase a person's risk of developing a recurrence (return) of colon cancer [ Time Frame: 3 Years ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	150
Study Start Date:	January 2006
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 Patients with colon cancer that was recently removed by surgery.	Behavioral: Questionnaire Two questionnaires taking 30 minutes to complete.

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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 with colon cancer that was recently removed by surgery.

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)].
All AJCC stage II patients must possess at least ONE high risk feature: bowel obstruction at presentation, T4(subscript) disease, poorly differentiated histology, < 10 lymph nodes surgically dissected for pathology review, or lymphovascular invasion.
Age >= 14 years 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.
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
U.T. M.D. 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

MD Anderson Cancer Center website This link exits the ClinicalTrials.gov site

Responsible Party:	U.T.M.D. Anderson Cancer Center ( Cathy Eng, MD/Assistant Professor )
Study ID Numbers:	2005-0383
Study First Received:	July 18, 2006
Last Updated:	August 26, 2008
ClinicalTrials.gov Identifier:	NCT00354705
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Colon Cancer
Adenocarcinoma of the Colon
Questionnaire
Cancer Recurrence
Survey

Study placed in the following topic categories:

Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Gastrointestinal Neoplasms
Intestinal Diseases

Adenocarcinoma
Colonic Neoplasms
Intestinal Neoplasms
Colorectal Neoplasms
Recurrence

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 14, 2009