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Study Summary
No. 2005-0383:.......Colon......Cathy Eng......Gastrointestinal Medical Oncology
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Study Summary Title
Study Summary
Number:		2005-0383
Study Title:Prognostic Molecular And Environmental Factors in Stage II and Stage III Colon Cancer Patients
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Physician New Patient Referral
Name:Cathy EngPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Gastrointestinal Medical OncologyReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-2828
Contact us about clinical trials
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General Information
Disease Group:ColonSupported By:N/A
Phase of Study:N/AReturn
Visit:		Every 3 months after completion of adjuvant chemotherapy or during surveillance
only, until 2 years from enrollment, or recurrence of disease, whichever occurs
first.
Treatment
Agents:		NoneHome Care:None
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:		None
Description/
Intervention:		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.
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Study Objectives / Outcomes
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 American Joint Committee on Cancer (AJCC) stage II (T3-4N0M0) patients and stage III (TxN1-3M0) colon carcinoma.
    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 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 after resection, at the conclusion of adjuvant chemotherapy (or if appropriate after ~6 months of surveillance only), and if appropriate, at time of disease recurrence for validation of tissue proteomics analysis.
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          Study Status Information
          Study Activation / Registration Date:01/12/2006
          IRB Review and Approval Date:06/21/2005
          Study Type:Observational
          Recruitment Status:Open
          Projected Accrual:N/A
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          Enrollment Eligibility
          If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.
          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.
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          Links
          Registration Number: NCT00354705
          Study Information on Clinical Trials Registry (clinicaltrials.gov)
          Other Links:
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          Results

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