MSI-H Colorectal CancerDNAMMRNCT05871567
Predictive Value of DNA Mismatch Repair System in Colorectal Cancers
An observational study of MSI-H Colorectal Cancer, run by University of Campania Luigi Vanvitelli.
Trial summary
Microsatellite instable (MSI) tumors represent almost the 15% of all sporadic colorectal cancers (CRCs). Literature data show that this unique tumor population appears to be poorly responsive to conventional chemotherapy and conversely reveals excellent results to immunotherapy. Read more about this study
- Who is it for?
- Ages 18 to 86 years
- Conditions the study is for
- MSI-H Colorectal Cancer
- What is being tested?
- colorectal resection
- Type of treatment
- Surgery or procedure
- How many people
- 403 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2014to 31 Mar 2023
- How long will I take part?
- 5 Years
- 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 to 86 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: CRC patients undergoing surgery
Who may be able to join
- all consecutive CRC patients observed from January 2014 to December 2021
Who cannot join
- Patients with suspected or confirmed Lynch's syndrome (12 patients) and rectal cancers (98 patients) undergoing neoadjuvant treatment
About this study
Official title: Assessment of the DNA Mismatch Repair System is Crucial in Colorectal Cancers Necessitating Adjuvant Treatment: a Propensity Score-matched and Win Ratio Analysis
- Microsatellite instable (MSI) tumors represent almost the 15% of all sporadic colorectal cancers (CRCs).
- Literature data show that this unique tumor population appears to be poorly responsive to conventional chemotherapy and conversely reveals excellent results to immunotherapy.
- Our data, as demonstrated by propensity score-matched and win ratio analysis, show that there are no substantial differences between MSI and MSS tumors in early CRC stages treated with surgery alone.
- On the contrary, stable tumors (MSS) did much better than MSI tumors in advanced CRC stages undergoing conventional adjuvant treatment.
- Determination of status of DNA mismatch repair system is crucial in high-risk CRCs to optimize treatment.
Read the detailed description
Colorectal cancers (CRCs) with deficient DNA mismatch repair (MMR) system (so called dMMR or MSI tumors) represent a no-negligible part of sporadic CRCs. Prognostic value of this unique cell population remains controversial, but undoubtedly these tumors are characterized by poor response to conventional chemotherapy, an high tumor mutational burden resulting in a brisk immuno response, and, as recently observed, excellent results to the immunotherapy. The aim of this study was to evaluate, by using sophisticated statistical analyses, the predictive value of MSI status and its optimal treatment.
A series of 403 consecutive CRC patients treated by the same oncological team from 2014 to 2021 entered the study. No patients underwent immunotherapy. Immunohistochemistry, integrated by polymerase chain reaction if appropriate, was used to categorize specimens in microsatellite stable (MSS) and instable (MSI) tumors. The win ratio (WR) approach was utilized to compare composite outcomes of MSS and MSI tumors while controlling for radical versus no radical resection, propensity score-matched analysis, and reversing primary endpoint.
- Conditions
- MSI-H Colorectal Cancer
- Being tested
- colorectal resection
- Keywords
- Colorectal cancers;, DNA mismatch repair;, Win ratio
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
colorectal resectionProcedure or surgery
potential resective surgery
| Study group | Role | What they receive |
|---|---|---|
| group 1 or MSS | colorectal cancers (CRCs) with stable microsatellite Receives: Procedure: colorectal resection | |
| group 2 or MSI | colorectal cancers (CRCs) with unstable microsatellite Receives: Procedure: colorectal resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
survival rate
overall survival
Measured: "From date of surgical operation until the date of death from any cause assessed up to 60 months"
Secondary outcomes (1)
recurrence rate
disease-free survival
Measured: "From date of surgical operation until the date of documented tumor recurrence assessed up to 60 months"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2023
- Study start1 Jan 2014
- Primary completion31 Dec 2021
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MSI-H 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 403 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- University of Campania Luigi Vanvitelli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gennaro Galizia, University of Campania Luigi Vanvitelli
- Investigators
- Gennaro Galizia, MD, Study director, University of Campania 'Luigi Vanvitelli'
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05871567
- Sponsor's protocol ID
- Università Vanvitelli Napoli
- Acronym
- DNAMMR
- Status last verified
- May 2023
- First submitted
- 4 May 2023
- Last updated
- 24 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data will be made available by contacting the principal investigator
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the DNA Mismatch Repair System is Crucial in Colorectal Cancers Necessitating Adjuvant Treatment: a Propensity Score-matched and Win Ratio Analysis
- ClinicalTrials.gov ID
- NCT05871567
- Acronym / sponsor ID
- DNAMMR / Università Vanvitelli Napoli
- Conditions
- MSI-H Colorectal Cancer
- Keywords
- Colorectal cancers;, DNA mismatch repair;, Win ratio
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 403 participants (actual)
- Lead sponsor
- University of Campania Luigi VanvitelliUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 23 May 2023 (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.
- Microsatellite instable (MSI) tumors represent almost the 15% of all sporadic colorectal cancers (CRCs).
- Literature data show that this unique tumor population appears to be poorly responsive to conventional chemotherapy and conversely reveals excellent results to immunotherapy.
- Our data, as demonstrated by propensity score-matched and win ratio analysis, show that there are no substantial differences between MSI and MSS tumors in early CRC stages treated with surgery alone.
- On the contrary, stable tumors (MSS) did much better than MSI tumors in advanced CRC stages undergoing conventional adjuvant treatment.
- Determination of status of DNA mismatch repair system is crucial in high-risk CRCs to optimize treatment.
Detailed description
Colorectal cancers (CRCs) with deficient DNA mismatch repair (MMR) system (so called dMMR or MSI tumors) represent a no-negligible part of sporadic CRCs. Prognostic value of this unique cell population remains controversial, but undoubtedly these tumors are characterized by poor response to conventional chemotherapy, an high tumor mutational burden resulting in a brisk immuno response, and, as recently observed, excellent results to the immunotherapy. The aim of this study was to evaluate, by using sophisticated statistical analyses, the predictive value of MSI status and its optimal treatment.
A series of 403 consecutive CRC patients treated by the same oncological team from 2014 to 2021 entered the study. No patients underwent immunotherapy. Immunohistochemistry, integrated by polymerase chain reaction if appropriate, was used to categorize specimens in microsatellite stable (MSS) and instable (MSI) tumors. The win ratio (WR) approach was utilized to compare composite outcomes of MSS and MSI tumors while controlling for radical versus no radical resection, propensity score-matched analysis, and reversing primary endpoint.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 or MSS | – | Procedure: colorectal resectioncolorectal cancers (CRCs) with stable microsatellite |
| group 2 or MSI | – | Procedure: colorectal resectioncolorectal cancers (CRCs) with unstable microsatellite |
Who may qualify
- Ages
- 18 to 86 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- CRC patients undergoing surgery
Key inclusion criteria (1 listed)
- all consecutive CRC patients observed from January 2014 to December 2021
Key exclusion criteria (1 listed)
- Patients with suspected or confirmed Lynch's syndrome (12 patients) and rectal cancers (98 patients) undergoing neoadjuvant treatment
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 |
|---|---|---|
| colorectal resectionpotential resective surgery | Procedure or surgery | group 1 or MSS, group 2 or MSI |
Primary outcome
survival rate
Time frame: "From date of surgical operation until the date of death from any cause assessed up to 60 months"
overall survival
1 secondary outcome
recurrence rate
Time frame: "From date of surgical operation until the date of documented tumor recurrence assessed up to 60 months"
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 24 May 2023.
- Individual participant dataSharing planned: Yes. All data will be made available by contacting the principal investigator
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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.
Gennaro Galizia, MD study director
University of Campania 'Luigi Vanvitelli'
Questions about this trial
What is this clinical trial studying?
An observational study of MSI-H Colorectal Cancer, run by University of Campania Luigi Vanvitelli.
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 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
survival rate (time frame: "From date of surgical operation until the date of death from any cause assessed up to 60 months"). 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 24 May 2023.