NCT02595645

Brief Summary

Colorectal cancer ist the 2nd most leading cancer among men and women in germany. Screening colonoscopy has the potential to detect premalignant lesions. By endoscopical resection of these lesions, colorectal cancers could be avoided. The decision for surveillance is made according to patients medical history, amount and histological characteristics of the resected polyps. Molecular guided decisions are still missing. Thus, further tools and mechanisms, beyond but in addition to endoscopy and histopathological, are strongly required to reduce such interval carcinomas and get a better and deeper inside into molecular alterations which occurs in premalignant lesions in the colon and describe risk populations which might benefit from shorter surveillance strategies by colonoscopy. Therefore GENESIS will enroll 100 patients, which underwent screening colonoscopy with polyp ectomy. All biopsies were stored and processed without formalin in special boxes (PaxGene by Qiagen®). After microdissection of polyp tissue and isolation of DNA targeted next generation sequencing of 38 cancer-related genes followed by bioinformatics and systems biology analyses. The sequencing results were correlated to the endoscopical and histopathological findings. In parallel we are collecting EDTA-blood samples for analysis of circulating cell-free DNA (cfDNA) to investigate the potential of liquid biopsies in premalignant colorectal lesions.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
101

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2015

Geographic Reach
2 countries

4 active sites

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

August 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 29, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 3, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

November 3, 2016

Status Verified

November 1, 2016

Enrollment Period

1 year

First QC Date

October 29, 2015

Last Update Submit

November 2, 2016

Conditions

Colonic Polyps

Keywords

colorectal adenomacolorectal cancernext generation sequencingliquid biopsyscreening colonoscopysurveillance strategies

Outcome Measures

Primary Outcomes (1)

  • Genetic landscape of colonic polyps based on NGS-analysis

    Are we able to describe risk populations based on clinical, histopathological and sequencing data which might bring a benefit for these cohort for shorter surveillance strategies by colonoscopy? What are the similarities in the altered genes, what are the differences? Are we able to define common signaling hubs?

    1 year

Study Arms (1)

Polypectomy and NGS

EXPERIMENTAL

All patients which underwent screening colonoscopy and fulfilling the inclusion criteria are eligible. Polyps were biopsied and underwent histopathological and genetic analyses

Genetic: Polypectomy and NGS

Interventions

Polypectomy and NGSGENETIC

NGS of 38 cancer-related genes, systems biological analyses, correlation genetics to pathology and clinical data

Polypectomy and NGS

Eligibility Criteria

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

You may qualify if:

  • written informed consent
  • indication of screening colonoscopy

You may not qualify if:

  • chronic inflammatory bowl disease
  • known colorectal cancer (except curative treated colorectal cancers more than 5 years ago)
  • disagreement in participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Medical University Graz

Graz, Styria, 8036, Austria

Location

Specialized Medical Office for Gastroenterology

Dornstadt, Baden-Wurttemberg, 89160, Germany

Location

University Ulm, Internal Medicine I, Interventional and Experimental Endoscopy (InExEn)

Ulm, Baden-Wurttemberg, 89081, Germany

Location

Technical University Munich

Munich, Bavaria, 81675, Germany

Location

MeSH Terms

Conditions

Colonic PolypsColorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal PolypsPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Alexander G. Meining, Prof. Dr.

    University Ulm, Internal Medicine I, Interventional and experimental endoscopy (InExEn)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. Alexander Meining

Study Record Dates

First Submitted

October 29, 2015

First Posted

November 3, 2015

Study Start

August 1, 2015

Primary Completion

August 1, 2016

Study Completion

October 1, 2016

Last Updated

November 3, 2016

Record last verified: 2016-11

Locations

AU(1)DE(3)