NCT05162248

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
231

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2021

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 5, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 17, 2021

Completed
Last Updated

December 17, 2021

Status Verified

December 1, 2021

Enrollment Period

4 months

First QC Date

December 5, 2021

Last Update Submit

December 5, 2021

Conditions

Colorectal CancerColorectal CarcinomaMicrosatellite Instability HighMicrosatellite Instability LowMicrosatellite Instability-High

Keywords

Colorectal cancerPrognostic factorMicrosatellite instabilityPrognosisSurvival

Outcome Measures

Primary Outcomes (2)

  • Overall Survival

    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.

    Five years

  • Disease-Free Survival

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

    Five years

Study Arms (1)

Microsatellite instability

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

Diagnostic Test: Microsatellite instability analysis

Interventions

Microsatellite instability analysisDIAGNOSTIC_TEST

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.

Microsatellite instability

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The population of the research consists of patients undergoing colorectal surgery at the Health Sciences University Sultan 2. Abdulhamid Training and Research Hospital between March 2017 and March 2021.

You may qualify if:

  • Colorectal surgery patients
  • Complete follow-up information

You may not qualify if:

  • Whose MSI status was not studied in the pathology material
  • Missing follow-up information
  • Colorectal resection for non-neoplastic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sultan 2. Abdulhamid Training and Research Hospital

Istanbul, 34668, Turkey (Türkiye)

Location

Related Publications (3)

  • Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.

    PMID: 33538338BACKGROUND

  • Gupta R, Sinha S, Paul RN. The impact of microsatellite stability status in colorectal cancer. Curr Probl Cancer. 2018 Nov;42(6):548-559. doi: 10.1016/j.currproblcancer.2018.06.010. Epub 2018 Jul 18.

    PMID: 30119911BACKGROUND

  • Boland CR, Goel A. Microsatellite instability in colorectal cancer. Gastroenterology. 2010 Jun;138(6):2073-2087.e3. doi: 10.1053/j.gastro.2009.12.064.

    PMID: 20420947BACKGROUND

MeSH Terms

Conditions

Colorectal NeoplasmsMicrosatellite Instability

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesGenomic InstabilityPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Taygun Gülşen, MD

    Sultan 2. Abdulhamid Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, General Surgeon

Study Record Dates

First Submitted

December 5, 2021

First Posted

December 17, 2021

Study Start

April 1, 2021

Primary Completion

July 15, 2021

Study Completion

August 1, 2021

Last Updated

December 17, 2021

Record last verified: 2021-12

Locations

TU(1)