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Molecular and Histological Characteristics of Serrated Lesions of the Colon

NCT03089268 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 700

Last updated 2023-10-02

No results posted yet for this study

Summary

Different subtypes of serrated lesions have been recently described. Among them, both sessile serrated polyp/adenoma (SSP/A) and traditional serrated adenoma (TSA) could have malignant potential through the serrated pathway or CIMP. These lesions, as a potential source of interval cancer, should also be considered in colorectal cancer (CRC) population-based screening programs. It is believed that this new described pathway could be responsible for up to 30% of all CRC.

Unlike the traditional adenoma, serrated lesions are difficult to diagnose because of their particular endoscopic appearance and their still unclear histological criteria. Furthermore, they have specific molecular changes and, through them, they could evolve into CRC faster than the adenoma. The real prevalence of the serrated lesions and their specific risk for developing new synchronous/metachronous lesions, or even malignancy, remains unknown. For all these reasons, we don't know if these patients could constitute a different CRC-risk group and if specific recommendations are needed during their follow-up.

This is a prospective longitudinal study developed within the framework of the CRC-screening program in the Valencian Community (Spain). We expect to include a total of 700 individuals who will be followed during 10 years.

In our study, we will collect epidemiologic variables related to the patient, variables related to all the polyps, and mutational (BRAF, KRAS, MSI), and CpG-island methylation status of serrated lesions. Strict endoscopic and histological criteria will be applied for the diagnosis of serrated lesions. All lesions detected at the index colonoscopy and during follow-up will be evaluated.

The purpose of this study is to correlate epidemiologic data, histological characteristics and the molecular profile of the serrated lesions with findings during follow-up, in order to define stratified groups according to their risk of developing new lesions or CRC in the future.

Conditions

Interventions

PROCEDURE

Colonoscopy

A colonoscopy will be performed to all individuals.

PROCEDURE

Polypectomy or biopsy

All lesions will be removed or biopsied during the procedure

GENETIC

Molecular analysis

Molecular analysis will be performed in all colorectal cancers and in those polyps diagnosed with "serrated lesion"

Sponsors & Collaborators

  • Hospital Universitario La Fe

    lead OTHER

Principal Investigators

  • Marco Bustamante, M.D.;Ph.D. · Hospital Universitari i Politècnic La Fe - Instituto de Investigación Sanitaria

Eligibility

Min Age
50 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-01
Primary Completion
2028-01-01
Completion
2028-01-01

Countries

  • Spain

Study Locations

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Entities

Diseases

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 NCT03089268 on ClinicalTrials.gov