Predictive Value of DNA Mismatch Repair System in Colorec... | NCT05871567

Studies
Predictive Value of DNA Mismatch Repair System in Colorectal Cancers

NCT05871567

Sponsor

University of Campania Luigi Vanvitelli

Status

Completed

Last Update Posted

May 24, 2023Actual

Enrollment

403Actual

Phase

Not provided

Conditions

MSI-H Colorectal Cancer

Interventions

colorectal resection

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2014Actual

Primary Completion Date

Dec 31, 2021Actual

Completion Date

Mar 31, 2023Actual

First Submitted Date

May 4, 2023

First Submission Date that Met QC Criteria

May 12, 2023

First Posted Date

May 23, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 22, 2023

Last Update Posted Date

May 24, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Gennaro Galizia, Full Professor of Surgery, University of Campania Luigi VanvitelliPrincipal Investigator

Lead Sponsor

University of Campania Luigi VanvitelliOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.
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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

403Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
group 1 or MSS		colorectal cancers (CRCs) with stable microsatellite	Procedure: colorectal resection
group 2 or MSI		colorectal cancers (CRCs) with unstable microsatellite	Procedure: colorectal resection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
colorectal resection	Procedure	potential resective surgery	group 1 or MSS group 2 or MSI

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
survival rate	overall survival	"From date of surgical operation until the date of death from any cause assessed up to 60 months"

Secondary Outcomes

Measure	Description	Time Frame
recurrence rate	disease-free survival	"From date of surgical operation until the date of documented tumor recurrence assessed up to 60 months"

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

all consecutive CRC patients observed from January 2014 to December 2021

Exclusion Criteria:

Patients with suspected or confirmed Lynch's syndrome (12 patients) and rectal cancers (98 patients) undergoing neoadjuvant treatment

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

86 Years

Standard Ages

AdultOlder Adult

Study Population

CRC patients undergoing surgery

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gennaro Galizia, MD	University of Campania 'Luigi Vanvitelli'	Study Director

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

All data will be made available by contacting the principal investigator

Types

Not provided

Time Frame

data will become available after conclusion of the trial and publication of the results. After that data will be available for two years.

Access Criteria

gennaro.galizia@unicampania.it

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015179	Colorectal Neoplasms

Ancestor Terms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site

Browse Leaves

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Browse Branches

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