Predictive Value of DNA Mismatch Repair System in Colorectal Cancers

NCT05871567 | Completed DMC

• 1 other identifier: Università Vanvitelli Napoli
• Study Type: observational
• Target: 403
• Locations: 0 countries
• Sites: N/A

Brief Summary

• Microsatellite instable (MSI) tumors represent almost the 15% of all sporadic colorectal cancers (CRCs).
• Literature data show that this unique tumor population appears to be poorly responsive to conventional chemotherapy and conversely reveals excellent results to immunotherapy.
• Our data, as demonstrated by propensity score-matched and win ratio analysis, show that there are no substantial differences between MSI and MSS tumors in early CRC stages treated with surgery alone.
• On the contrary, stable tumors (MSS) did much better than MSI tumors in advanced CRC stages undergoing conventional adjuvant treatment.
• Determination of status of DNA mismatch repair system is crucial in high-risk CRCs to optimize treatment.

Conditions

MSI-H Colorectal Cancer

Keywords

Colorectal cancers;; DNA mismatch repair;; Win ratio

Outcome Measures

Primary Outcomes (1)

• survival rate

  overall survival

  "From date of surgical operation until the date of death from any cause assessed up to 60 months"

Secondary Outcomes (1)

• recurrence rate

  "From date of surgical operation until the date of documented tumor recurrence assessed up to 60 months"

Study Arms (2)

group 1 or MSS

colorectal cancers (CRCs) with stable microsatellite

Procedure: colorectal resection

group 2 or MSI

colorectal cancers (CRCs) with unstable microsatellite

Procedure: colorectal resection

Interventions

colorectal resection PROCEDURE

potential resective surgery

group 1 or MSS; group 2 or MSI

Eligibility Criteria

• Age: 18 Years - 86 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

CRC patients undergoing surgery

You may qualify if:

• all consecutive CRC patients observed from January 2014 to December 2021

You may not qualify if:

• Patients with suspected or confirmed Lynch's syndrome (12 patients) and rectal cancers (98 patients) undergoing neoadjuvant treatment

Sponsors & Collaborators

• University of Campania Luigi Vanvitelli: lead

Biospecimen

Retention: SAMPLES WITH DNA

specimens from surgical resection

MeSH Terms

Conditions

Colorectal Neoplasms

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

Study Officials

• Gennaro Galizia, MD

  University of Campania 'Luigi Vanvitelli'

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor of Surgery

Study Record Dates

• First Submitted: May 4, 2023
• First Posted: May 23, 2023
• Study Start: January 1, 2014
• Primary Completion: December 31, 2021
• Study Completion: March 31, 2023
• Last Updated: May 24, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Time Frame: data will become available after conclusion of the trial and publication of the results. After that data will be available for two years.
• Access Criteria: gennaro.galizia@unicampania.it