Colorectal CancerNCT04976439
Patogenic Mutation in 5 Genes
An observational study of Colorectal Cancer and APC Gene Mutation, run by Dr Cipto Mangunkusumo General Hospital at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, APC Gene Mutation, TP53 Gene Mutation
- What is being tested?
- co-occuring mutation
- How many people
- 22 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 May 2021to 14 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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). .
Who may be able to join
- FFPE samples fullfilling purity criterion and pass quality control
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Colorectal Cancer, APC Gene Mutation, TP53 Gene Mutation, PIK3CA Gene Mutation, KRAS Mutation-Related Tumors, MLH1 Gene Mutation
- Being tested
- co-occuring mutation
- Keywords
- next-generation sequencing, colorectal cancer, indonesia population, co-occurring mutation
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
co-occuring mutationOther
APC, TP53, PIK3CA, KRAS APC, TP53, PIK3CA, MLH1 APC, TP53, PIK3CA, KRAS, and MLH1 APC, TP53, PIK3CA
| Study group | Role | What they receive |
|---|---|---|
| Age | Not described Receives: Other: co-occuring mutation | |
| Grade | Not described Receives: Other: co-occuring mutation | |
| Tumor location | Not described Receives: Other: co-occuring mutation | |
| Stage | Not described Receives: Other: co-occuring mutation | |
| Lymphovascular invasion | Not described Receives: Other: co-occuring mutation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of clinical characteristics
Age, gender
Measured: January 2017 - June 2021
Description of tumor nature
grade, stage, lymphovascular invasion, tumor location
Measured: January 2017 - June 2021
Description of survival
Median of life expectancy
Measured: January 2017 - June 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2021
- Study start1 May 2021
- Primary completion10 Jun 2021
- Study completion14 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr Cipto Mangunkusumo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vania Myralda Giamour Marbun, Dr Cipto Mangunkusumo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04976439
- Sponsor's protocol ID
- MUTASICRC
- Status last verified
- Jul 2021
- First submitted
- 2 Jul 2021
- Last updated
- 26 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genomic Landscape of APC, KRAS, TP53, PIK3CA, and MLH1 in Colorectal
- ClinicalTrials.gov ID
- NCT04976439
- Acronym / sponsor ID
- MUTASICRC
- Conditions
- Colorectal Cancer, APC Gene Mutation, TP53 Gene Mutation, PIK3CA Gene Mutation, KRAS Mutation-Related Tumors, MLH1 Gene Mutation
- Keywords
- next-generation sequencing, colorectal cancer, indonesia population, co-occurring mutation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Dr Cipto Mangunkusumo General HospitalUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 10 Jun 2021 (actual)
- Study completion
- 14 Jun 2021 (actual)
- First posted
- 26 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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). .
Key inclusion criteria (1 listed)
- FFPE samples fullfilling purity criterion and pass quality control
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| co-occuring mutationAPC, TP53, PIK3CA, KRAS APC, TP53, PIK3CA, MLH1 APC, TP53, PIK3CA, KRAS, and MLH1 APC, TP53, PIK3CA | Other | Age, Grade, Lymphovascular invasion, Stage, Tumor location |
Primary outcome
Description of clinical characteristics
Time frame: January 2017 - June 2021
Age, gender
Description of tumor nature
Time frame: January 2017 - June 2021
grade, stage, lymphovascular invasion, tumor location
Description of survival
Time frame: January 2017 - June 2021
Median of life expectancy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and APC Gene Mutation, run by Dr Cipto Mangunkusumo General Hospital at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Description of clinical characteristics (time frame: January 2017 - June 2021). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2021.