Comparison of Barium Enema, Computed Tomographic Colonography, and Colonoscopy in Detecting Colon Cancer

NCT00016029 | Terminated

• 5 other identifiers: 0866DUMC-000866-00-5RDUMC-CA14326NCI-V01-1655CDR0000068587
• Study Type: interventional
• Target: 775
• Locations: 1 country
• Sites: 14

Brief Summary

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.

Conditions

Colorectal Cancer

Keywords

colon cancer; rectal cancer

Interventions

screening questionnaire administration OTHER

barium enema injection PROCEDURE

computed tomography PROCEDURE

computed tomography colonography PROCEDURE

diagnostic colonoscopy PROCEDURE

screening colonoscopy PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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: * Hemoglobin less than 13 g/dL (males) * Hemoglobin less than 12 g/dL (females) * Ferritin less than 45 g/dL * Episode of bright red blood per the rectum * Family history of colon cancer or adenoma * One first-degree relative diagnosed with colon cancer or adenoma at age 60 or under OR * Two first-degree relatives diagnosed with colon cancer or adenoma at any age * No active gastrointestinal hemorrhage, including any of the following: * Reported or witnessed hematemesis * Melenic stools * Melenemesis * Multiple episodes of hematochezia within the past 2 months PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * See Disease Characteristics Hepatic: * Not specified Renal: * Not specified Cardiovascular: * No myocardial infarction or cerebrovascular accident within the past 6 weeks Pulmonary: * No respiratory failure within the past 6 weeks 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 need for special precautions in performing endoscopic procedures (e.g., antibiotic prophylaxis or complicated anticoagulation reversal) * No prisoners * Not pregnant * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Not specified Endocrine therapy: * Not specified Radiotherapy: * Not specified Surgery: * Not specified Other: * No other concurrent clinical trial participation involving drugs, medical devices, and/or biologics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Duke University: lead

Study Sites (14)

Rebecca and John Moores UCSD Cancer Center

La Jolla, California, 92093-0658, United States

Location

California Pacific Medical Center - Pacific Campus

San Francisco, California, 94115, United States

Location

California Pacific Medical Center - California Campus

San Francisco, California, 94118-1618, United States

Location

Veterans Affairs Medical Center - San Francisco

San Francisco, California, 94121, United States

Location

Indian River Radiology

Vero Beach, Florida, 32960, United States

Location

University of Chicago Cancer Research Center

Chicago, Illinois, 60637-1470, United States

Location

Troy Internal Medicine, P.C.

Troy, Michigan, 48098, United States

Location

Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08903, United States

Location

NYU School of Medicine's Kaplan Comprehensive Cancer Center

New York, New York, 10016, United States

Location

Veterans Affairs Medical Center - Durham

Durham, North Carolina, 27705, United States

Location

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

Simmons Cancer Center - Dallas

Dallas, Texas, 75235-9154, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

Massey Cancer Center

Richmond, Virginia, 23298-0037, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms; Rectal Neoplasms

Interventions

Barium Enema

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Fluoroscopy; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Enema; Drug Therapy; Therapeutics

Study Officials

• Don Rockey, MD

  Duke Cancer Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Purpose: DIAGNOSTIC
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2001
• First Posted: January 27, 2003
• Study Start: August 1, 2000
• Study Completion: August 1, 2005
• Last Updated: March 22, 2013

Record last verified: 2003-09

Locations

US (14)