Molecular and Histological Characteristics of Serrated Lesions of the Colon

NCT03089268 | Active Not Recruiting

• 1 other identifier: PSC-01A
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 1

Brief 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

Colonic Neoplasms; Colorectal Cancer; Sessile Serrated Adenoma; Polyp of Colon

Keywords

sessile serrated polyp; prevalence; colorectal cancer; molecular biology

Outcome Measures

Primary Outcomes (1)

• Risk of developing metachronous advanced lesions or cancers

  To assess the risk of developing metachronous advanced lesions or cancers in FOBT screening population

  2017-2027

Secondary Outcomes (2)

• Genetic defects of colorectal cancer and serrated lesions

  15/04/17- 15/04/18

• Prevalence of serrated lesions in FOBT screening population

  15/04/17- 15/04/18

Study Arms (1)

Group 1

Individuals scheduled for colonoscopy at Hospital Universitari i Politècnic La Fe, participating in the Valencian CRC screening program, will be recruited. Polypectomy or biopsy will be performed if necessary (following current guidelines). Specific molecular analysis of serrated lesions and CRC will be carried out.

Procedure: Colonoscopy; Procedure: Polypectomy or biopsy; Genetic: Molecular analysis

Interventions

Colonoscopy PROCEDURE

A colonoscopy will be performed to all individuals.

Group 1

Polypectomy or biopsy PROCEDURE

All lesions will be removed or biopsied during the procedure

Group 1

Molecular analysis GENETIC

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

Group 1

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All individuals undergoing a colonoscopy after a positive FOBT result within the framework of the CRC-screening program in the Hospital Universitari i Politècnic La Fe (Valencia) in the Valencian Community (Spain).

You may qualify if:

• Patient undergoing a colonoscopy after a positive FOBT

You may not qualify if:

• Previous diagnose of inflammatory bowel disease
• Previous colon surgery
• Hereditary CRC syndrome
• Coagulation disorders
• Refusal of the individual to participate and sign informed consent

Sponsors & Collaborators

• Hospital Universitario La Fe: lead

Study Sites (1)

Hospital Universitari i Politècnic La Fe

Valencia, 46026, Spain

Location

Biospecimen

Retention: SAMPLES WITH DNA

colonic polyp or colorectal cancer samples

MeSH Terms

Conditions

Colonic Neoplasms; Colorectal Neoplasms; Colonic Polyps

Interventions

Colonoscopy; Biopsy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Specimen Handling; Investigative Techniques

Study Officials

• Marco Bustamante, M.D.;Ph.D.

  Hospital Universitari i Politècnic La Fe - Instituto de Investigación Sanitaria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gastrointestinal Endoscopy Consultant

Study Record Dates

• First Submitted: March 20, 2017
• First Posted: March 24, 2017
• Study Start: June 1, 2017
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: October 2, 2023

Record last verified: 2023-09

Locations

ES (1)