MSI-CRC: Microsatellite Instability in Colorectal Cancers

Sponsor
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey (Other)
Overall Status
Completed
CT.gov ID
NCT05162248
Collaborator
(none)
231
1
4
57.6

Study Details

Study Description

Brief Summary

In this study, we aimed to identify the different histopathological features of tumors with microsatellite instability (MSI) compared to microsatellite stable (MSS) in patients who underwent surgery for colorectal cancer. We also planned to determine how MSI affects prognostic parameters.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Microsatellite instability analysis

Detailed Description

According to Global Cancer Statistics, higher than 1.9 million new cases of colorectal cancer (CRC) and 935,000 deaths are estimated to occur in 2020, representing about one in 10 cancer cases and deaths. Overall, it ranks third in colorectal incidence but second in mortality.

In CRC evolution, the acquisition of genomic instability is a critical point, and there are at least two different pathways in the pathogenesis of CRC: the chromosomal instability (CIN) pathway (85%) and the microsatellite instability (MSI) pathway (15%).

Microsatellite instability (MSI) is a phenotype that occurs due to a malfunction in the DNA repair mechanism and is seen in approximately 15% of colorectal cancers (CRCs). CRCs with MSI have different clinical features, such as a tendency to settle in the proximal colon, poor differentiation, and more lymphocytic infiltration in the tumor. It has been shown that CRCs with MSI have a better prognosis and respond differently to chemotherapy than CRCs with microsatellite stable (MSS).

We aimed to evaluate the different histopathological features of tumors with MSI compared to MSS in patients who underwent surgery for colorectal cancer. We also planned to determine how MSI affects prognostic parameters such as mortality rate, recurrence, disease-free survival, cancer-specific survival, and overall survival.

Study Design

Study Type:
Observational
Actual Enrollment :
231 participants
Observational Model:
Other
Time Perspective:
Retrospective
Official Title:
Clinicopathological Outcomes of Microsatellite Instability in Colorectal Cancer
Actual Study Start Date :
Apr 1, 2021
Actual Primary Completion Date :
Jul 15, 2021
Actual Study Completion Date :
Aug 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Microsatellite instability

Immunohistochemical analysis was performed for Microsatellite Instability (MSI) status of colorectal tumors tissue.

Diagnostic Test: Microsatellite instability analysis
Molecular analysis for Microsatellite Instability (MSI) status was performed using immunohistochemistry (IHC). IHC now recognized as an approved method to highly precision predict MSI in colorectal cancer.

Outcome Measures

Primary Outcome Measures

  1. Overall Survival [Five years]

    Overall survival is defined as the time interval from the time of primary operation to the date of all-cause death or the last follow-up.

  2. Disease-Free Survival [Five years]

    Disease-Free Survival is defined as the time interval from the time of primary operation to disease recurrence or death.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All
Inclusion Criteria:
  • Colorectal surgery patients

  • Complete follow-up information

Exclusion Criteria:
  • Whose MSI status was not studied in the pathology material

  • Missing follow-up information

  • Colorectal resection for non-neoplastic diseases

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sultan 2. Abdulhamid Training and Research Hospital Istanbul Turkey 34668

Sponsors and Collaborators

  • Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Investigators

  • Principal Investigator: Taygun Gülşen, MD, Sultan 2. Abdulhamid Training and Research Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Taygun Gulsen, MD, General Surgeon, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
ClinicalTrials.gov Identifier:
NCT05162248
Other Study ID Numbers:
  • s2021.crc
First Posted:
Dec 17, 2021
Last Update Posted:
Dec 17, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Taygun Gulsen, MD, General Surgeon, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 17, 2021