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GENESIS: Genetic Biopsy for Prediction of Surveillance Intervals After Endoscopic Resection of Colonic Polyps

NCT02595645 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2016-11-03

No results posted yet for this study

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.

Conditions

  • Colonic Polyps

Interventions

GENETIC

Polypectomy and NGS

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

Sponsors & Collaborators

  • Technical University of Munich

    collaborator OTHER

  • Medical University of Graz

    collaborator OTHER

  • Specialized Medical Office for Gastroenterology Dornstadt

    collaborator OTHER

  • QIAGEN Gaithersburg, Inc

    collaborator INDUSTRY

  • University of Ulm

    lead OTHER

Principal Investigators

  • Alexander G. Meining, Prof. Dr. · University Ulm, Internal Medicine I, Interventional and experimental endoscopy (InExEn)

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2016-08-31
Completion
2016-10-31

Countries

  • Austria
  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02595645 on ClinicalTrials.gov