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Home > "G" Clinical Trials Conditions > Genetic Study of Young Patients With Colorectal Cancer  Genetic Study of Young Patients With Colorectal Cancer
Genetic Study of Young Patients With Colorectal Cancer
For Condition: hereditary non-polyposis colon cancer (hMSH2, hMLH1, hPMS1, hPMS2),Colon Cancer,Rectal Cancer
Status: Recruiting
Sponsor(s): American College of Surgeons , National Cancer Institute (NCI)
Synopsis: RATIONALE: Identifying genemutations (microsatellite instability) may allow doctors to plan effective treatment for patients who develop colorectal cancer at an early age. PURPOSE: Genetictrial to determine the significance of gene mutations in helping predict the outcome of treatment in patients who develop stage I, stage II, or stage III colorectal cancer at an early age.
Details: OBJECTIVES: - Evaluate the prognostic significance (e.g., overall survival) of microsatellite instability (MSI) status in patients with early age-of-onset stage I-III colorectal cancer, assuming the presence of a quantitative interaction between MSI status and family history of cancer. - Evaluate the development of metachronous neoplasms in this patient population. - Evaluate the histologic features and genetic changes associated with hereditary nonpolyposis colorectal cancer in this patient population. OUTLINE: This is a multicenter study. Patients are stratified according to family history using the Amsterdam II criteria for hereditary nonpolyposis colorectal cancer (positive vs negative). Patients undergo baseline colonoscopy before or within 6 months of initial curative resection and then surveillance colonoscopy at 1, 3, and 5 years (+/- 6 months) after resection. The number, size, location, histology, and method of removal of polyps are documented at the time of colonoscopy. Patients also undergo microsatellite instability (MSI) status testing at baseline and complete family history questionnaires at baseline and then at 3 months. Markers used to determine MSI status include BAT loci (BAT-26 [MSH2 intragenic repeat] and BAT-25), D5S346, D2S123, and D17S50. The prognostic significance of family history and MSI status is evaluated. The individual histologic features of the tumors are compared with the MSI status to determine their predictive value. The histologic features are also correlated with outcome to determine their prognostic significance. Patients may be referred for genetic counseling. A certificate of confidentiality protecting the identity of research participants in this project has been issued by the National Cancer Institute. PROJECTED ACCRUAL: A total of 3,000 patients will be accrued for this study within 6 years.
Eligibility:
Study Type: Interventional, Diagnostic
Minimum Age/Maximum Age: 18 Years/49 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of stage I-III adenocarcinoma of the colon or rectum - Must have undergone an initial curative resection within the past year - No colon or rectal cancer resection that does not allow for definitive T or N staging - No initial post-surgical surveillance colonoscopy prior to study entry - Must have a pathology specimen, with representative normal and tumor tissues, available for submission to the ACOSOG Central Specimen Bank prior to study entry - No personal or family history of familial adenomatous polyposis - No recurrent colorectal cancer PATIENT CHARACTERISTICS: Age - 18 to 49 at first diagnosis Performance status - Not specified Life expectancy - Not specified Hematopoietic - Not specified Hepatic - Not specified Renal - Not specified Other - Must be willing to provide a family cancer history to the study team and continue with follow-up colonoscopic surveillance - No other malignancy within the past 5 years except completely resected cervical cancer or nonmelanoma skin cancer - No evidence of recurrence of other prior malignancy PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - Not specified Endocrine therapy - Not specified Radiotherapy - No prior pelvic radiotherapy for rectal cancer - No concurrent preoperative pelvic radiotherapy for rectal cancer Surgery - See Disease Characteristics
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JoseGuillem, Study Chair, Memorial Sloan-Kettering Cancer Center
Fletcher Allen Health Care - Medical Center Campus *Recruiting*
Burlington, Vermont, 05401
United States
Recruiting Neil Hyman 802-847-3339
Western Pennsylvania Hospital *Recruiting*
Pittsburgh, Pennsylvania, 15224
United States
Recruiting Philip Caushaj 412-578-4024
William Beaumont Hospital - Royal Oak *Recruiting*
Royal Oak, Michigan, 48073
United States
Recruiting Gary Chmielewski 248-551-0669
University of Minnesota Cancer Center *Recruiting*
Minneapolis, Minnesota, 55455
United States
Recruiting David Rothenberger 612-626-6122
Cardinal Bernardin Cancer Center at Loyola University Medical Center *Recruiting*
Maywood, Illinois, 60153
United States
Recruiting Sheryl Gabram 708-327-2695
St. Agnes Cancer Center *Recruiting*
Baltimore, Maryland, 21229
United States
Recruiting Armando Sardi 410-368-2702
Presbyterian Hospital *Recruiting*
Charlotte, North Carolina, 28233-3549
United States
Recruiting Peter Turk 704-377-3900
Duke Comprehensive Cancer Center *Recruiting*
Durham, North Carolina, 27710
United States
Recruiting Douglas Tyler 919-684-6858
Toronto Sunnybrook Regional Cancer Centre *Recruiting*
Toronto, Ontario, M4N 3M5
Canada
Recruiting Andrew Smith 416-480-4027
Cleveland Clinic Taussig Cancer Center *Recruiting*
Cleveland, Ohio, 44195
United States
Recruiting Eric Klein 216-444-5591
Integris Oncology Services *Recruiting*
Oklahoma City, Oklahoma, 73112
United States
Recruiting Chris Davis 405-948-0640
McLaren Regional Cancer Center *Recruiting*
Flint, Michigan, 48432
United States
Recruiting Sukamal Saha 810-230-9600
Central Baptist Hospital *Recruiting*
Lexington, Kentucky, 40503-9985
United States
Recruiting Peter Tate 606-277-5711
James P. Wilmot Cancer Center at University of Rochester Medical Center *Recruiting*
Rochester, New York, 14642
United States
Recruiting David Johnstone 585-275-1509
Lahey Clinic Medical Center - Burlington *Recruiting*
Burlington, Massachusetts, 01805
United States
Recruiting David Schoetz 781-744-8889
University of Texas - MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030-4009
United States
Recruiting Raphael Pollock 713-792-6928
Baptist Cancer Institute - Memphis at Baptist Memorial Hospital - Memphis *Recruiting*
Memphis, Tennessee, 38120
United States
Recruiting Derrick Beech 901-448-1542
Morton Plant Hospital *Recruiting*
Clearwater, Florida, 33756
United States
Recruiting Peter Blumencranz 424-446-5681
Abramson Cancer Center at University of Pennsylvania Medical Center *Recruiting*
Philadelphia, Pennsylvania, 19104-4283
United States
Recruiting Douglas Fraker 215-662-7866
Baylor University Medical Center *Recruiting*
Dallas, Texas, 75246
United States
Recruiting Joseph Kuhn 214-824-9963
University of Chicago Cancer Research Center *Recruiting*
Chicago, Illinois, 60637-1470
United States
Recruiting Fabrizio Michelassi 773-702-6237
University of Wisconsin Comprehensive Cancer Center *Recruiting*
Madison, Wisconsin, 53792-7375
United States
Recruiting John Niederhuber 608-265-5212
Froedtert Memorial Lutheran Hospital *Recruiting*
Milwaukee, Wisconsin, 53226
United States
Recruiting Alonzo Walker 414-454-5737
Shands Cancer Center at the University of Florida Health Science Center *Recruiting*
Gainesville, Florida, 32610-100277
United States
Recruiting Robert W. Marsh 352-392-0058
Ellis Fischel Cancer Center at University of Missouri - Columbia *Recruiting*
Columbia, Missouri, 65203
United States
Recruiting Lisa Jacobs 573-882-8454
Medical College of Wisconsin Cancer Center *Recruiting*
Milwaukee, Wisconsin, 53226
United States
Recruiting Alonzo Walker 414-805-4450
Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City, New York, 10021
United States
Recruiting Jose Guillem 212-639-8278
Sarah Cannon Cancer Center at Parkridge Medical Center *Recruiting*
Chattanooga, Tennessee, 37404-3285
United States
Recruiting John Gwin 423-493-1690
Comprehensive Cancer Center at Wake Forest University *Recruiting*
Winston Salem, North Carolina, 27157-1082
United States
Recruiting Edward Levine 336-716-4276
Rush Copley Medical Center *Recruiting*
Aurora, Illinois, 60504-4206
United States
Recruiting H. Dobson 630-585-0200
Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital *Recruiting*
Ft. Lauderdale, Florida, 33308
United States
Recruiting Leonard Seigel 954-267-7700
Allegheny General Hospital *Recruiting*
Pittsburgh, Pennsylvania, 15212-4772
United States
Recruiting Sandra Jones 412-359-3901
Additional Information:
Study ID Numbers: CDR0000069465; ACOSOG-Z0190
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00044967
Other Rectal Cancer Studies:
1. Interleukin-12 in Treating Patients With Cancer in the Abdomen
2. Surgery With or Without Radiofrequency Ablation Followed by Irinotecan in Treating Patients With Colorectal Cancer That is Metastatic to the Liver
3. Biological Therapy in Treating Patients With Metastatic Cancer
4. Celecoxib With or Without Eflornithine in Preventing Colorectal Cancer in Patients With Familial Adenomatous Polyposis.
5. Combination Chemotherapy in Treating Patients With Liver Metastases from Colorectal Cancer
Related Studies:
Other Rectal Cancer Clinical Trials
Other North Carolina Clinical Trials
Other Durham Clinical Trials
Genetic Study of Young Patients With Colorectal Cancer
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