NCT07536113

Recruiting

Assessing the Efficacy and Safety of ctDNA-driven Selection ...

Niguarda Hospital Source

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Other study identifiers

Sponsor study identifier

4855

Study Type

observational

Estimated enrollment

250

Locations

1 country

Sites

1

Timeline

Study Start

March 1, 2024

Actual (reported)

Primary Completion

May 1, 2026

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

September 1, 2026

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Brief Summary

This is an observational, retrospective, international and multicenter study funded by Fondazione Oncologia Niguarda ETS to assess the efficacy of anti-EGFR rechallenge regimens in the largest real-world cohort of MSS mCRC patients screened for RAS/BRAF/PIK3CA ctDNA status on liquid biopsy within the MEN1611-02 C-PRECISE-01 trial. The study will collect molecular, clinical and outcome data of patients already available at participating centers.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: recruiting
Estimated enrollment: 250 participants
Study completion date: September 1, 2026
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
March 1, 2024
Actual (reported)
First Submitted
March 8, 2026
Actual (reported)
First Posted
April 17, 2026
Actual (reported)
Primary Completion
May 1, 2026
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 1, 2026
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated: April 17, 2026
Status Verified: April 2026
Last Update Submitted: April 15, 2026

Conditions

Metastatic Colorectal Cancer (CRC)

Keywords

liquid biopsymCRCrechallenge therapiesAnti-EGFR

Outcome Measures

Primary Outcomes (1)

Efficacy anti-EGFR rechallenge
The study aims primarily at assessing the efficacy of anti-EGFR rechallenge in the largest real-world cohort of MSS mCRC patients according to RAS/BRAF/PIK3CA ctDNA status taking advantage from the liquid biopsy screening performed as per MEN1611-02 C-PRECISE-01 trial.
Up to two years

Study Arms (1)

mCRC patients

Patients diagnosed with mCRC and screened by ctDNA within the MEN1611-02 clinical trial.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Patients diagnosed with MSS RAS and BRAF wild-type (on solid tissue) mCRC

You may qualify if:

Patients diagnosed with MSS RAS and BRAF wild-type (on solid tissue) mCRC and screened by ctDNA within the MEN1611-02 clinical trial;

Sponsors & Collaborators

Niguarda Hospital
Otherlead

Study Sites (1)

ASST GOM Niguarda

Milan, Italia, Italy

RECRUITING

Salvatore Siena, MDCONTACT+39026444 ext. 3695 salvatore.siena@ospedaleniguarda.it

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

Salvatore Siena, MD
ASST Niguarda Hospital
PRINCIPAL INVESTIGATOR

Central Study Contacts

Salvatore Siena, MD

CONTACT

+39026444 salvatore.siena@ospedaleniguarda.it

Study Design

Study Type: observational
Observational Model: OTHER
Time Perspective: RETROSPECTIVE
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

March 8, 2026

First Posted

April 17, 2026

Study Start

March 1, 2024

Actual (reported)

Primary Completion

May 1, 2026

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Not Applicable

Not Yet Recruiting

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Phase 2Recruiting

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Phase 1Recruiting

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Phase 2Recruiting

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Phase 2Not Yet Recruiting

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Phase 3Recruiting

Informed consent signature from alive patient;

Availability of clinical data detailing the outcome to the first treatment received by patients following the blood draw for ctDNA analysis performed as per screening procedures within the MEN1611-02 clinical trial;

Signed informed consent for molecular screening within the MEN1611-02 clinical trial.

Age ≥ 18.

You may not qualify if:

No data available detailing the outcome to the first treatment received by patients following the blood draw for ctDNA analysis performed as per screening procedures within the MEN1611-02 clinical trial.
Patients enrolled and treated within the MEN1611-02 clinical trial.

Contact the study team to confirm eligibility.

Study Completion

September 1, 2026

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated

April 17, 2026

Record last verified: 2026-04

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT07536113
Data provider: ClinicalTrials.gov
Source updated: 2026-04-17
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:35:06 UTC

Locations

IT(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

mCRC patients

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations