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Sponsors and Collaborators: |
Fox Chase Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00450424 |
RATIONALE: The use of a CD-ROM may help patients with colorectal cancer or a family history of colorectal cancer make informed decisions about undergoing microsatellite instability (MSI) testing.
PURPOSE: This randomized phase I/II trial is studying an educational CD-ROM to see how well it works compared with standard informed consent to assist decision-making about MSI testing in patients with colorectal cancer or a family history of colorectal cancer.
Condition | Intervention | Phase |
---|---|---|
Colorectal Cancer Hereditary Non-Polyposis Colon Cancer (hmsh2, hmlh1, hpms1, hpms2) |
Procedure: counseling Procedure: educational intervention Procedure: immunohistochemistry staining method Procedure: laboratory biomarker analysis Procedure: microsatellite instability analysis Procedure: mutation analysis Procedure: polymerase chain reaction |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Randomized |
Official Title: | Facilitating Informed Decisions for MSI Testing |
Estimated Enrollment: | 184 |
Study Start Date: | June 2005 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, pilot, phase I study followed by a randomized, phase II study.
Phase II: Patients are randomized to 1 of 2 arms.
All patients in phase II (even those that did not consent to the MSI test) complete a follow-up survey at 2 weeks.
Tissue samples from patients are analyzed by immunohistochemistry and MSI assay (polymerase chain reaction) for MLH1 and MSH2.
PROJECTED ACCRUAL: A total of 184 patients will be accrued for this study.
Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Patient or family member meeting 1 of the following revised Bethesda colorectal cancer (CRC) criteria:
Patients with CRC meeting the Amsterdam criteria defined below are ineligible:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, Delaware | |
Helen F. Graham Cancer Center at Christiana Hospital | Recruiting |
Newark, Delaware, United States, 19713 | |
Contact: Clinical Trials Office - Helen F. Graham Cancer Center 302-733-6227 | |
United States, Massachusetts | |
Massachusetts General Hospital | Recruiting |
Boston, Massachusetts, United States, 02114 | |
Contact: Clinical Trials Office - Massachusetts General Hospital 877-726-5130 | |
United States, Pennsylvania | |
Fox Chase Cancer Center - Philadelphia | Recruiting |
Philadelphia, Pennsylvania, United States, 19111-2497 | |
Contact: Clinical Trials Office - Fox Chase Cancer Center - Philadelphi 215-728-4790 |
Principal Investigator: | Sharon Manne, PhD | Fox Chase Cancer Center |
Study ID Numbers: | CDR0000443988, FCCC-04827 |
Study First Received: | March 20, 2007 |
Last Updated: | October 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00450424 |
Health Authority: | Unspecified |
colon cancer rectal cancer hereditary non-polyposis colon cancer (hMSH2, hMLH1, hPMS1, hPMS2) recurrent colon cancer stage I colon cancer stage II colon cancer stage III colon cancer |
stage IV colon cancer recurrent rectal cancer stage I rectal cancer stage II rectal cancer stage III rectal cancer stage IV rectal cancer |
Metabolic Diseases Digestive System Neoplasms Rectal Neoplasms Gastrointestinal Diseases Colonic Diseases Hereditary nonpolyposis colon cancer Intestinal Diseases Rectal Diseases Recurrence Intestinal Neoplasms |
Rectal neoplasm Neoplastic Syndromes, Hereditary Digestive System Diseases Genetic Diseases, Inborn Colorectal Neoplasms, Hereditary Nonpolyposis Gastrointestinal Neoplasms Metabolic disorder Rectal cancer Colonic Neoplasms Colorectal Neoplasms |
Neoplasms Neoplasms by Site DNA Repair-Deficiency Disorders |