Clinical trial NCT05162248: Microsatellite Instability in Colorectal Cancers
Official title: Clinicopathological Outcomes of Microsatellite Instability in Colorectal Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Colorectal Carcinoma
Microsatellite Instability High
Microsatellite Instability Low
Microsatellite Instability-High
Keywords: Colorectal cancer
Prognostic factor
Microsatellite instability
Prognosis
Survival
Lead sponsor: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Sponsor class: OTHER
First posted: 2021-12-17
Enrollment: 231
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall Survival
timeFrame: Five years
measure: Disease-Free Survival
timeFrame: Five years
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Sultan 2. Abdulhamid Training and Research Hospital
Study officials:
affiliation: Sultan 2. Abdulhamid Training and Research Hospital
name: Taygun Gülşen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.