NCT00905710

Brief Summary

Lynch syndrome (LS), or hereditary nonpolyposis colorectal cancer (HNPCC), is a hereditary disorder predisposing for colorectal cancer. To reduce the risk of colorectal cancer, patients undergo colonoscopy every 1-2 years. Chromoendoscopy is relatively new technique which improves the detection of adenomas, the precursor lesions of colorectal cancer. The aim of this study is to determine whether chromoendoscopy, including polypectomy of all detected lesions, reduces the development of colorectal neoplasia and the need for colectomy in LS patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2008

Longer than P75 for not_applicable

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

September 1, 2008

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 18, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 20, 2009

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

May 13, 2016

Status Verified

May 1, 2016

Enrollment Period

7.7 years

First QC Date

May 18, 2009

Last Update Submit

May 12, 2016

Conditions

Lynch Syndrome

Keywords

colorectal adenomascolorectal cancerLynch syndromechromoendoscopy

Outcome Measures

Primary Outcomes (1)

  • The primary endpoints of the study are the number of adenomas, advanced adenomas, carcinomas at baseline and the number of the number of adenomas, advanced adenomas, carcinomas and the number of patients requiring colectomy at 2-year follow-up.

    2 years

Secondary Outcomes (1)

  • The secondary endpoints of the study are the number of complications from colonoscopy at baseline and at 2-year follow-up.

    baseline and 2 years

Study Arms (2)

1

NO INTERVENTION

Conventional colonoscopy

2

EXPERIMENTAL

Colonoscopy using chromoendoscopy

Procedure: Chromoendoscopy

Interventions

ChromoendoscopyPROCEDURE

Chromoendoscopy: spraying of the mucosa of the right colon with indigo-carmine

2

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • proven carrier of a MLH1, MSH2 or MSH6 mutation
  • age between 20 and 70 years
  • written informed consent

You may not qualify if:

  • previous large bowel surgery
  • psychological/physical conditions hampering compliance with the study protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Groningen

Groningen, Netherlands

Location

Related Publications (3)

  • Stoffel EM, Turgeon DK, Stockwell DH, Normolle DP, Tuck MK, Marcon NE, Baron JA, Bresalier RS, Arber N, Ruffin MT, Syngal S, Brenner DE; Great Lakes New England Clinical Epidemiology and Validation Center of the Early Detection Research Network. Chromoendoscopy detects more adenomas than colonoscopy using intensive inspection without dye spraying. Cancer Prev Res (Phila). 2008 Dec;1(7):507-13. doi: 10.1158/1940-6207.CAPR-08-0096.

    PMID: 19139000BACKGROUND

  • Huneburg R, Lammert F, Rabe C, Rahner N, Kahl P, Buttner R, Propping P, Sauerbruch T, Lamberti C. Chromocolonoscopy detects more adenomas than white light colonoscopy or narrow band imaging colonoscopy in hereditary nonpolyposis colorectal cancer screening. Endoscopy. 2009 Apr;41(4):316-22. doi: 10.1055/s-0028-1119628. Epub 2009 Apr 1.

    PMID: 19340735BACKGROUND

  • Haanstra JF, Dekker E, Cats A, Nagengast FM, Hardwick JC, Vanhoutvin SA, de Vos Tot Nederveen Cappel WH, Vasen HF, Kleibeuker JH, Koornstra JJ. Effect of chromoendoscopy in the proximal colon on colorectal neoplasia detection in Lynch syndrome: a multicenter randomized controlled trial. Gastrointest Endosc. 2019 Oct;90(4):624-632. doi: 10.1016/j.gie.2019.04.227. Epub 2019 Apr 24.

    PMID: 31028782DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms, Hereditary NonpolyposisColorectal Neoplasms

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

Study Officials

  • Jan J Koornstra, MD PhD

    University Medical Center Groningen, netherlands

    PRINCIPAL INVESTIGATOR

  • Jan H Kleibeuker, MD PhD

    University Medical Center Groningen, Netherlands

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
dr

Study Record Dates

First Submitted

May 18, 2009

First Posted

May 20, 2009

Study Start

September 1, 2008

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

May 13, 2016

Record last verified: 2016-05

Locations

NL(1)