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Screening Tests in Detecting Colorectal Cancer Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about Screening Tests in Detecting Colorectal Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Screening Tests in Detecting Colorectal Cancer Clinical research trials and Screening Tests in Detecting Colorectal Cancer health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Screening Tests in Detecting Colorectal Cancer. Screening Tests in Detecting Colorectal Cancer Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a Screening Tests in Detecting Colorectal Cancer clinical trial. Human subjects often get the best healthcare possible for their Screening Tests in Detecting Colorectal Cancer condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "S" Clinical Trials Conditions > Screening Tests in Detecting Colorectal Cancer  Screening Tests in Detecting Colorectal Cancer
Screening Tests in Detecting Colorectal Cancer
For Condition: Rectal Cancer,Colon Cancer
Status: Recruiting
Sponsor(s): Mayo Clinic Cancer Center , National Cancer Institute (NCI),North Central Cancer Treatment Group
Synopsis: RATIONALE: Screening tests may help doctors detect cancer cells early and plan more effective treatment for colorectal cancer. PURPOSE: Randomized screening trial to compare the effectiveness of fecal occult blood testing to DNA-based testing of stool and blood in identifying colorectal cancer.
Details: OBJECTIVES: - Compare the performance characteristics (sensitivity, specificity, and predictive values) of fecal occult blood (FOB) testing and multitarget DNA-based assay panel (MTAP) testing applied to stools and plasma in identifying colorectal cancer. - Compare the specificity of the MTAP and FOB tests in participants given pretest dietary restrictions vs no pretest dietary restrictions in order to evaluate the necessity of a formal pretest preparation for MTAP. - Compare the detection rates of colorectal neoplasia using MTAP alone, flexible sigmoidoscopy alone, and combination sigmoidoscopy and FOB testing. - Determine the causes of MTAP "false-positive" results, (i.e., positive MTAP and negative colonoscopy). - Determine and compare the pathological and molecular features of colorectal cancer detected vs not detected by the MTAP. OUTLINE: This is a randomized, multicenter study. Participants are stratified according to gender and participating center. Participants are randomized to one of two screening arms. - Arm I: Participants eat no red meat and take no nonsteroidal anti-inflammatory drugs (NSAIDs) and no vitamin C or multivitamins for 3 days prior to and during stool sample collection. Participants collect stool samples 3 different times and perform fecal occult blood (FOB) test smears from each stool. After each collection, participants ship the whole stool and FOB test smear to their participating center for blinded multitarget DNA-based assay panel (MTAP) testing. - Arm II: Participants take no vitamin C or multivitamins for 3 days before and during stool sample collection. Participants collect stool samples and FOB test smears and samples are tested as in arm I. Within 2 months after stool sample collection, participants have their blood drawn for additional MTAP testing and undergo colonoscopy. PROJECTED ACCRUAL: A total of 4,000 participants (2,000 per arm) will be accrued for this study.
Eligibility:
Study Type: Observational, Screening
Minimum Age/Maximum Age: 65 Years/80 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Average risk of colorectal cancer and meets the following criteria: - More than 1 year since prior fecal occult blood test - More than 10 years since prior structural colorectal evaluation (i.e., colonoscopy, colon x-ray, or sigmoidoscopy) - More than 1 month since prior overt rectal bleeding (hematochezia or melena) - More than 5 years since prior aerodigestive cancer - No prior colorectal resection - No contraindications to colonoscopy - No high-risk conditions for colorectal cancer, such as the following: - Familial adenomatous polyposis - Hereditary nonpolyposis colorectal cancer syndrome - Other hereditary cancer syndromes - Prior colorectal cancer or adenoma - Inflammatory bowel disease - Two or more first-degree relatives with colorectal cancer PATIENT CHARACTERISTICS: Age: - 65 to 80 Performance status: - Not specified Menopausal status: - Postmenopausal, with the following qualifications: - No menstrual period within the past year - On regular hormone replacement therapy - Underwent surgical intervention Life expectancy: - Not specified Hematopoietic: - No coagulopathy Hepatic: - Not specified Renal: - Not specified Cardiovascular: - No serious cardiopulmonary disease Pulmonary: - See Cardiovascular PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - At least 3 months since prior chemotherapy Endocrine therapy: - Not specified Radiotherapy: - Not specified Surgery: - See Disease Characteristics Other: - No concurrent therapeutic nonsteroidal anti-inflammatory drugs except prophylactic aspirin - No concurrent anticoagulants
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DavidAhlquist, Study Chair, Mayo Clinic Cancer Center
CCOP - Illinois Oncology Research Association *Recruiting*
Peoria, Illinois, 61602
United States
Recruiting John Kugler 309-636-3605
CCOP - Merit Care Hospital *Recruiting*
Fargo, North Dakota, 58122
United States
Recruiting Preston Steen 701-234-6161
CCOP - Upstate Carolina *Recruiting*
Spartanburg, South Carolina, 29303
United States
Recruiting James Bearden 864-560-7050
CCOP - Iowa Oncology Research Association *Recruiting*
Des Moines, Iowa, 50309-1016
United States
Recruiting Roscoe Morton 515-244-7586
CCOP - Cedar Rapids Oncology Project *Recruiting*
Cedar Rapids, Iowa, 52403-1206
United States
Recruiting Martin Wiesenfeld 319-363-8303
CentraCare Health Plaza *Recruiting*
St. Cloud, Minnesota, 56303
United States
Recruiting Harold Windschitl 320-229-5199
CCOP - Missouri Valley Cancer Consortium *Recruiting*
Omaha, Nebraska, 68106
United States
Recruiting James Mailliard 402-280-4364
Mayo Clinic Cancer Center *Recruiting*
Rochester, Minnesota, 55905
United States
Recruiting David Ahlquist 507-284-2511
CCOP - Mayo Clinic Scottsdale Oncology Program *Recruiting*
Scottsdale, Arizona, 85259-5404
United States
Recruiting Tom Fitch 480-301-9875
CCOP - Carle Cancer Center *Recruiting*
Urbana, Illinois, 61801
United States
Recruiting Kendrith Rowland 217-383-4083
CCOP - Ochsner *Recruiting*
New Orleans, Louisiana, 70121
United States
Recruiting Carl Kardinal 504-842-3910
CCOP - Geisinger Clinic and Medical Center *Recruiting*
Danville, Pennsylvania, 17822-2001
United States
Recruiting Suresh Nair 570-271-6413
CCOP - Michigan Cancer Research Consortium *Recruiting*
Ann Arbor, Michigan, 48106
United States
Recruiting Philip Stella 734-712-2000
Siouxland Hematology-Oncology *Recruiting*
Sioux City, Iowa, 51101-1733
United States
Recruiting Donald Wender 712-252-0088
CCOP - Sioux Community Cancer Consortium *Recruiting*
Sioux Falls, South Dakota, 57104
United States
Recruiting Loren Tschetter 605-328-8044
Mayo Clinic *Recruiting*
Jacksonville, Florida, 32224
United States
Recruiting Edith Perez 904-953-0118
Rapid City Regional Hospital *Recruiting*
Rapid City, South Dakota, 57709
United States
Recruiting Larry Ebbert 605-341-8704
CCOP - Wichita *Recruiting*
Wichita, Kansas, 67214-3882
United States
Recruiting Shaker Dakhil 316-268-5784
Additional Information:
Study ID Numbers: CDR0000068783; NCI-P01-0185,NCCTG-MC9944,MAYO-MC9944
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00025025
Other Colon Cancer Studies:
1. Aspirin and/or Folic Acid in Preventing Recurrent Colorectal Polyps
2. Celecoxib With or Without Eflornithine in Preventing Colorectal Cancer in Patients With Familial Adenomatous Polyposis.
3. Curcumin for the Prevention of Colon Cancer
4. Conventional Care With or Without Specialized Cancer Care in Treating Patients Receiving Chemotherapy
5. Genetic Study of Patients and Families With a History of Colorectal Cancer
Related Studies:
Other Colon Cancer Clinical Trials
Other South Dakota Clinical Trials
Other Sioux Falls Clinical Trials
Screening Tests in Detecting Colorectal Cancer
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