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CompletedNCT05162248MSI-CRCUpdated Dec 17, 2021

Microsatellite Instability in Colorectal Cancers

An observational study in Colorectal Cancer, Colorectal Carcinoma and Microsatellite Instability High, sponsored by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey. Completed at 1 site in Turkey. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2021-12-17.

Sponsored by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey · Observational

Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
231
Ages
18 Years to 100 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Colorectal Cancer
  • Colorectal Carcinoma
  • Microsatellite Instability High
  • Microsatellite Instability Low
  • Microsatellite Instability-High

Keywords

  • Colorectal cancer
  • Prognostic factor
  • Microsatellite instability
  • Prognosis
  • Survival
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In context

Colorectal Neoplasms

6,541 studies on the registry are indexed under Colorectal Neoplasms; 1,667 are open to participants now.

This study's enrollment of 231 is close to the median of 250 across 1,440 observational studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey is the lead sponsor of 108 studies on the registry; 31 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Sampling method
Non-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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Colorectal surgery patients
  • Complete follow-up information

Exclusion criteria

Exclusion Criteria:

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

Observational model
Other
Time perspective
Retrospective
Enrollment
231 participants (actual)
Patient registry
No

Groups and cohorts

  • Microsatellite instability

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

    Diagnostic Test: Microsatellite instability analysis

Interventions

  • Diagnostic testMicrosatellite 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Five years

  2. Disease-Free Survival

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

    Time frame: Five years

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Study locations

1 site
  • Sultan 2. Abdulhamid Training and Research Hospital
    Istanbul, 34668, Turkey
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References and documents

Publications

  • 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. PubMed 33538338 ↗
  • 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. PubMed 30119911 ↗
  • 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. PubMed 20420947 ↗

Individual participant data

Plan to share: Undecided — Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Apr 2021 to primary completion in Jul 2021, 3 months.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 5, 2021
First posted
Dec 17, 2021
StartActual
Apr 1, 2021
Primary completionActual
Jul 15, 2021
CompletionActual
Aug 1, 2021
Last update
Dec 17, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 17, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05162248
Responsible party
Taygun Gulsen (MD, General Surgeon, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey) — Principal investigator
First posted
Dec 17, 2021
Start date
Apr 1, 2021
Primary completion
Jul 15, 2021
Completion
Aug 1, 2021
Last update
Dec 17, 2021

Study contacts

Taygun Gülşen, MD
principal investigator · Sultan 2. Abdulhamid Training and Research Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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