NCT03434925

Brief Summary

This project is dedicated to identify the patients with possible higher risk of adenoma recurrence who should have follow-up colonoscopy in yearly interval. As a result, it can lead to optimizing the of follow-up colonoscopies intervals in real-world practice.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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, 2017

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 31, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 15, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

February 15, 2018

Status Verified

February 1, 2018

Enrollment Period

2.8 years

First QC Date

January 31, 2018

Last Update Submit

February 14, 2018

Conditions

Colon Cancer

Keywords

colorectal neoplasiaadenomacolonoscopygene mutationfollow-uprecurrencemultiparametric test

Outcome Measures

Primary Outcomes (1)

  • Presence of genetic markers for local recurence after resection of colorectal neoplasia

    Measurement of gene mutations associated with local recurrence of advanced colorectal neoplasia after endoscopic resection.

    3 years

Secondary Outcomes (2)

  • Risk of polyp recurrence

    3 years

  • Topographic heterogenity of polyps

    3 years

Interventions

Multi-targeted next generation sequencingGENETIC

Study directed at finding molecular predictors of recurrent colorectal adenomas also taking into account the intrinsic level of heterogenity imprinted in the internal differences in molecular profiles

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Colorectal polyp larger than 10mm removed by colonoscopy therapeutic method (EPE, EMR, ESD)
  • Signed informed consent with the study and with colonoscopy

You may not qualify if:

  • FAP, HNPCC and other hereditary CRC syndromes probands
  • Recent diagnostic, follow-up or preventive colonoscopy (FOBT-positive colonoscopy, screening colonoscopy) in ≤ 3 years
  • Colonoscopy contraindication
  • Severe acute inflammatory bowel disease
  • Severe comorbidities; likely non-compliance of the patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Military University Hospital

Prague, 16902, Czechia

RECRUITING

Related Publications (1)

  • Grega T, Kmochova K, Hejcmanova K, Ngo O, Brodyuk N, Majek O, Bures J, Urbanek P, Zavoral M, Suchanek S. Impact of narrow band imaging in prediction of histology of advanced colorectal neoplasia. Sci Rep. 2025 Jan 9;15(1):1414. doi: 10.1038/s41598-025-85669-w.

    PMID: 39789214DERIVED

MeSH Terms

Conditions

Colonic NeoplasmsAdenomaRecurrence

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Stepan Suchanek, MD., Ph.D.

    Military University Hospital

    STUDY DIRECTOR

Central Study Contacts

Stepan Suchanek, MD., Ph.D.

CONTACT

973208367stepan.suchanek@uvn.cz

Michal Voska, MD.

CONTACT

973203050michal.voska@uvn.cz

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD., Ph.D.

Study Record Dates

First Submitted

January 31, 2018

First Posted

February 15, 2018

Study Start

April 1, 2017

Primary Completion

January 1, 2020

Study Completion

December 31, 2020

Last Updated

February 15, 2018

Record last verified: 2018-02

Locations

CZ(1)