Patogenic Mutation in 5 Genes

July 21, 2021 updated by: Vania Myralda Giamour Marbun, Dr Cipto Mangunkusumo General Hospital

Genomic Landscape of APC, KRAS, TP53, PIK3CA, and MLH1 in Colorectal

This is a pathogenic mutation profile of colorectal patients specifically in 5 genes, i.e. APC, TP53, PIK3CA, KRAS, and MLH1. Single nucleotide variants identified were synchronized with patients' characteristics.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

22

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • ALL
      • Jakarta, ALL, Indonesia, 12740
        • Vania Myralda Giamour Marbun

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

This is a descriptive study in patients with colorectal malignancies who underwent surgery and/or chemoradiation and/or chemotherapy at RSCM, RSKJ, and MRCCC in 2017-2018 whose tumor tissue specimens were still properly stored in the form of formalin-fixed paraffin-embedded (FFPE). .

Description

Inclusion Criteria:

  • FFPE samples fullfilling purity criterion and pass quality control

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Age
Other: co-occuring mutation
APC, TP53, PIK3CA, KRAS APC, TP53, PIK3CA, MLH1 APC, TP53, PIK3CA, KRAS, and MLH1 APC, TP53, PIK3CA
Grade
Other: co-occuring mutation
APC, TP53, PIK3CA, KRAS APC, TP53, PIK3CA, MLH1 APC, TP53, PIK3CA, KRAS, and MLH1 APC, TP53, PIK3CA
Tumor location
Other: co-occuring mutation
APC, TP53, PIK3CA, KRAS APC, TP53, PIK3CA, MLH1 APC, TP53, PIK3CA, KRAS, and MLH1 APC, TP53, PIK3CA
Stage
Other: co-occuring mutation
APC, TP53, PIK3CA, KRAS APC, TP53, PIK3CA, MLH1 APC, TP53, PIK3CA, KRAS, and MLH1 APC, TP53, PIK3CA
Lymphovascular invasion
Other: co-occuring mutation
APC, TP53, PIK3CA, KRAS APC, TP53, PIK3CA, MLH1 APC, TP53, PIK3CA, KRAS, and MLH1 APC, TP53, PIK3CA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Description of clinical characteristics
Time Frame: January 2017 - June 2021
Age, gender
January 2017 - June 2021
Description of tumor nature
Time Frame: January 2017 - June 2021
grade, stage, lymphovascular invasion, tumor location
January 2017 - June 2021
Description of survival
Time Frame: January 2017 - June 2021
Median of life expectancy
January 2017 - June 2021

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr Cipto Mangunkusumo General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2021

Primary Completion (Actual)

June 10, 2021

Study Completion (Actual)

June 14, 2021

Study Registration Dates

First Submitted

July 2, 2021

First Submitted That Met QC Criteria

July 21, 2021

First Posted (Actual)

July 26, 2021

Study Record Updates

Last Update Posted (Actual)

July 26, 2021

Last Update Submitted That Met QC Criteria

July 21, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MUTASICRC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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