Clinical Trials Logo
  1. Home
  2. Colon Cancer
  3. NCT00245492
  4. Details
NCT00245492 Clinical Trial

Chromocolonoscopy for the Detection of Flat Adenomas in Routine Colorectal Cancer Screening.

Colon Cancer Clinical Trial

Official title:
Chromocolonoscopy for the Detection of Flat Adenomas in Routine Colorectal Cancer Screening.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00245492
Other study ID # 0508-64
Secondary ID 2005ACG-100CRC
Status Completed
Phase N/A
First received October 26, 2005
Last updated January 27, 2009
Start date May 2006
Est. completion date December 2008

Study information
Verified date January 2009
Source Indiana University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The proposed research aims to determine the prevalence, size, shape and histology of flat colorectal neoplasms in a cohort of asymptomatic, average-risk individuals presenting for screening colonoscopy. Patients will be randomized to either conventional colonoscopy or chromocolonoscopy, where the entire colon will be sprayed with indigocarmine dye and examined in the usual manner. The primary outcome will be the total number of adenomas detected, with special attention to the subgroup of flat and depressed lesions. To promote the generalizability of the results, neoplasms will be described according to standard Western and Japanese classification schemes.

Recruitment information / eligibility
Status Completed
Enrollment 792
Est. completion date December 2008
Est. primary completion date December 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 50 Years and older
Eligibility Inclusion Criteria:

- Patients undergoing screening colonoscopy

Exclusion Criteria:

- Age < 50

- Prior colon resection

- Inflammatory bowel disease

- Prior colonoscopy or sigmoidoscopy

- More than one first-degree relative with colon cancer

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Procedure:
• Chromocolonoscopy
Indigocarmine dye applied to entire colon to highlight mucosal detail and enhance detection of flat lesions.

Locations
Country Name City State
United States Indiana University Indianapolis Indiana
United States Roudebush VA Medical Center Indianapolis Indiana
United States SUNY Stony Brook Stony Brook New York

Sponsors (4)
Lead Sponsor Collaborator
Indiana University American College of Gastroenterology, Stony Brook University, University of Chicago

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Prevalence of adenomas detected by chromocolonoscopy versus standard colonoscopy. Cross-sectional prevalence of adenomas between the 2 study groups No
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05551052 - CRC Detection Reliable Assessment With Blood
Completed NCT03457454 - Reducing Rural Colon Cancer Disparities
Recruiting NCT06006390 - CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors Phase 1/Phase 2
Active, not recruiting NCT04088955 - A Digimed Oncology PharmacoTherapy Registry
Recruiting NCT06010862 - Clinical Study of CEA-targeted CAR-T Therapy for CEA-positive Advanced/Metastatic Malignant Solid Tumors Phase 1
Terminated NCT01347645 - Irinotecan Plus E7820 Versus FOLFIRI in Second-Line Therapy in Patients With Locally Advanced or Metastatic Colon or Rectal Cancer Phase 1/Phase 2
Completed NCT03390907 - Hybrid APC Assisted EMR for Large Colon Polyps N/A
Recruiting NCT03175224 - APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors Phase 2
Completed NCT04079478 - The AID Study: Artificial Intelligence for Colorectal Adenoma Detection
Active, not recruiting NCT04057274 - Acute Effect of modeRate-intensity aerOBIc Exercise on Colon Cancer Cell Growth N/A
Recruiting NCT03190941 - Administering Peripheral Blood Lymphocytes Transduced With a Murine T-Cell Receptor Recognizing the G12V Variant of Mutated RAS in HLA-A*11:01 Patients Phase 1/Phase 2
Not yet recruiting NCT05147545 - Impact of Exercise and Hyperlipidic Meal on Free Circulating DNA in Patients With Metastatic Colonic Cancer and Healthy Subjects N/A
Recruiting NCT05026268 - The Laparoscopic Right Colectomy With Intracoroporeal Anastomosis N/A
Not yet recruiting NCT03277235 - Effect of a Resilience Model-Based Care Plan in Newly Diagnosed Colorectal Cancer Patients N/A
Active, not recruiting NCT02730702 - Colon Cancer Risk-stratification Via Optical Analysis of Rectal Ultrastructure
Active, not recruiting NCT02959541 - PK/PD Investigation of Calciumfolinat in Blood, Tumor and Adjacent Mucosa in Patient With Colon Cancer N/A
Completed NCT02810652 - Perioperative Geriatrics Intervention for Older Cancer Patients Undergoing Surgical Resection N/A
Recruiting NCT02577627 - Multi-Indication, Retrospective Oncological Study to Validate the Accuracy in Predicting TTP by PrediCare in Patients Under SOC N/A
Terminated NCT02628535 - Safety Study of MGD009 in B7-H3-expressing Tumors Phase 1
Recruiting NCT02526836 - Complete Mesocolic Excision With Central Vessel Ligation Compared With Conventional Surgery for Colon Cancer Phase 2/Phase 3