NCT00313755

Brief Summary

The purpose of this study is to determine whether a new colonoscopic viewing technique called narrow band imaging (NBI)can help doctors detect more patients with at least one pre-cancerous area than conventional colonoscopy using white light alone in patients with genetically inherited high risk for bowel cancer (HNPCC).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

April 10, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 12, 2006

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

November 16, 2007

Status Verified

November 1, 2006

First QC Date

April 10, 2006

Last Update Submit

November 15, 2007

Conditions

Colorectal Neoplasms, Hereditary Nonpolyposis

Keywords

colonoscopy, narrow band imaging,high definition endoscopycolorectal cancerdysplasiahereditary non-polyposis colorectal cancerLynch SyndromeHNPCC

Outcome Measures

Primary Outcomes (3)

  • Number of patients with at least one adenoma

  • after white light endoscopy compared with the number of patients

  • with at least one adenoma after white light NBI in the right colon.

Secondary Outcomes (3)

  • Total number of lesions detected with white light vs NBI.

  • Number of advanced neoplasm detected with white light vs NBI.

  • Number of hyperplastic polyps detected by white light vs NBI.

Interventions

Narrow Band ImagingPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with HNPCC according to the Amsterdam II criteria
  • patients over 18 years

You may not qualify if:

  • pregnant patients
  • unable or unwilling to give consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

North West London Hospitals NHS Trust - St Mark's

London, Middlesex, HA1 3UJ, United Kingdom

Location

Related Publications (1)

  • East JE, Suzuki N, Stavrinidis M, Guenther T, Thomas HJ, Saunders BP. Narrow band imaging for colonoscopic surveillance in hereditary non-polyposis colorectal cancer. Gut. 2008 Jan;57(1):65-70. doi: 10.1136/gut.2007.128926. Epub 2007 Aug 6.

    PMID: 17682000DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms, Hereditary NonpolyposisColorectal Neoplasms

Interventions

Narrow Band Imaging

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsNeoplastic Syndromes, HereditaryDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDNA Repair-Deficiency DisordersMetabolic DiseasesNutritional and Metabolic DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Optical ImagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Brian Saunders, MD FRCP

    London North West Healthcare NHS Trust

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 10, 2006

First Posted

April 12, 2006

Study Start

April 1, 2006

Study Completion

September 1, 2007

Last Updated

November 16, 2007

Record last verified: 2006-11

Locations

GB(1)