NCT04976439

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 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

May 1, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2021

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 14, 2021

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

July 2, 2021

Completed
24 days until next milestone

First Posted

Study publicly available on registry

July 26, 2021

Completed
Last Updated

July 26, 2021

Status Verified

July 1, 2021

Enrollment Period

1 month

First QC Date

July 2, 2021

Last Update Submit

July 21, 2021

Conditions

Colorectal CancerAPC Gene MutationTP53 Gene MutationPIK3CA Gene MutationKRAS Mutation-Related TumorsMLH1 Gene Mutation

Keywords

next-generation sequencingcolorectal cancerindonesia populationco-occurring mutation

Outcome Measures

Primary Outcomes (3)

  • Description of clinical characteristics

    Age, gender

    January 2017 - June 2021

  • Description of tumor nature

    grade, stage, lymphovascular invasion, tumor location

    January 2017 - June 2021

  • Description of survival

    Median of life expectancy

    January 2017 - June 2021

Study Arms (5)

Age

Other: co-occuring mutation

Grade

Other: co-occuring mutation

Tumor location

Other: co-occuring mutation

Stage

Other: co-occuring mutation

Lymphovascular invasion

Other: co-occuring mutation

Interventions

co-occuring mutationOTHER

APC, TP53, PIK3CA, KRAS APC, TP53, PIK3CA, MLH1 APC, TP53, PIK3CA, KRAS, and MLH1 APC, TP53, PIK3CA

AgeGradeLymphovascular invasionStageTumor location

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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). .

You may qualify if:

  • FFPE samples fullfilling purity criterion and pass quality control

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vania Myralda Giamour Marbun

Jakarta, ALL, 12740, Indonesia

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator - Staff of Digestive Division - General Surgery Department

Study Record Dates

First Submitted

July 2, 2021

First Posted

July 26, 2021

Study Start

May 1, 2021

Primary Completion

June 10, 2021

Study Completion

June 14, 2021

Last Updated

July 26, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

ID(1)