Assessing the Efficacy and Safety of ctDNA-driven Selection for Anti-EGFR Retreatment in a Real World Metastatic Colorectal Cancer Patients Cohort (the REalCHALLENGE Study)

NCT07536113 | Recruiting

• 1 other identifier: 4855
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Colorectal Cancer (CRC)

Keywords

liquid biopsy; mCRC; rechallenge therapies; Anti-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

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-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;
• 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.

Sponsors & Collaborators

• Niguarda Hospital: lead

Study Sites (1)

ASST GOM Niguarda

Milan, Italia, Italy

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal 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
• Primary Completion: May 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-04

Locations

IT (1)