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| ID | Type | Description | Link |
|---|---|---|---|
| DUMC-000866-00-5R | |||
| DUMC-CA14326 | |||
| NCI-V01-1655 | |||
| CDR0000068587 | Other Identifier | NCI |
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RATIONALE: Screening tests may help doctors detect cancer cells early and plan more effective treatment for cancer. New diagnostic procedures such as computed tomographic colonography may provide a less invasive method of identifying patients who have colon cancer.
PURPOSE: Diagnostic and screening trial to compare the effectiveness of barium enema, computed tomographic colonography, and colonoscopy in detecting of colon cancer.
OBJECTIVES:
OUTLINE: This is a multicenter study.
A repeat fecal occult blood test is performed. Patients then undergo an air contrast barium enema (ACBE). At 7-10 days after ACBE, patients undergo a computed tomographic colonography (virtual colonoscopy) followed by a colonoscopy on the same day.
A repeat ACBE may be performed if there is a discrepancy between the initial ACBE and colonoscopy. If the repeat ACBE continues to show an abnormality, patients undergo a second colonoscopy.
Within 24 hours of completion of each test, patients fill out a questionnaire about their experience. At 5-7 days after completion of all tests, patients complete a final questionnaire comparing all 3 tests.
PROJECTED ACCRUAL: A total of 2,133 patients will be accrued for this study within 4 years.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| screening questionnaire administration | Other | |||
| barium enema injection | Procedure | |||
| computed tomography | Procedure | |||
| computed tomography colonography | Procedure | |||
| diagnostic colonoscopy | Procedure | |||
| screening colonoscopy | Procedure |
DISEASE CHARACTERISTICS:
One of the following must be present:
At least 1 positive fecal occult blood test within the past 6 months
Iron deficiency anemia, defined as:
Episode of bright red blood per the rectum
Family history of colon cancer or adenoma
No active gastrointestinal hemorrhage, including any of the following:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
No serious medical disorder (e.g., sepsis) within the past 6 weeks
Weight less than 300 pounds
Willing and able to undergo endoscopic or radiologic procedures
No prisoners
Not pregnant
Negative pregnancy test
Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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| Name | Affiliation | Role |
|---|---|---|
| Don Rockey, MD | Duke Cancer Institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rebecca and John Moores UCSD Cancer Center | La Jolla | California | 92093-0658 | United States | ||
| California Pacific Medical Center - Pacific Campus |
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| San Francisco |
| California |
| 94115 |
| United States |
| California Pacific Medical Center - California Campus | San Francisco | California | 94118-1618 | United States |
| Veterans Affairs Medical Center - San Francisco | San Francisco | California | 94121 | United States |
| Indian River Radiology | Vero Beach | Florida | 32960 | United States |
| University of Chicago Cancer Research Center | Chicago | Illinois | 60637-1470 | United States |
| Troy Internal Medicine, P.C. | Troy | Michigan | 48098 | United States |
| Robert Wood Johnson Medical School | New Brunswick | New Jersey | 08903 | United States |
| NYU School of Medicine's Kaplan Comprehensive Cancer Center | New York | New York | 10016 | United States |
| Veterans Affairs Medical Center - Durham | Durham | North Carolina | 27705 | United States |
| Duke Comprehensive Cancer Center | Durham | North Carolina | 27710 | United States |
| Simmons Cancer Center - Dallas | Dallas | Texas | 75235-9154 | United States |
| University of Texas Medical Branch | Galveston | Texas | 77555 | United States |
| Massey Cancer Center | Richmond | Virginia | 23298-0037 | United States |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D003110 | Colonic Neoplasms |
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| D000071941 | Barium Enema |
| ID | Term |
|---|---|
| D005471 | Fluoroscopy |
| D011859 | Radiography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004733 | Enema |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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