Metastatic Colorectal Cancer (CRC)RealCHALLENGENCT07536113
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)
An observational study of Metastatic Colorectal Cancer (CRC), run by Niguarda Hospital at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer (CRC)
- How many people
- 250 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2024to 1 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patients diagnosed with MSS RAS and BRAF wild-type (on solid tissue) mCRC
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
ASST GOM Niguarda
Milan, Italia
Salvatore Siena, MD, +39026444 ext. 3695, salvatore.siena@ospedaleniguarda.it
About this study
Official title: Assessing the Efficacy and Safety of ctDNA-driven Selection for Anti-EGFR Retreatment in a Real World Metastatic Colorectal Cancer Patients Cohort
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.
Read the detailed description
Patient's data to be collected include: age, gender, ethnicity; Eastern Cooperative Oncology Group scale performance status (ECOGPS); date of first diagnosis and date of advanced CRC diagnosis; primary tumor histology; timing of collection of FFPE and liquid biopsy samples; molecular profile data both from archival solid tissue and liquid biopsy; number and sites of metastasis at the time of liquid biopsy draw; medical treatment regimens, lines and locoregional approaches pursued, focusing on the first treatment received by patients following ctDNA analysis; date of death or last follow up. Response evaluation to therapies have to be assessed according to Response Evaluation Criteria in solid tumors (RECIST v1.1) criteria. Information will be provided about resposne to standard treatments (RR and DCR), duration of response (DOR), progression-free survival (PFS), time-to-treatment failure (TTF), OS.
- Conditions
- Metastatic Colorectal Cancer (CRC)
- Keywords
- liquid biopsy, mCRC, rechallenge therapies, Anti-EGFR
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| mCRC patients | Patients diagnosed with mCRC and screened by ctDNA within the MEN1611-02 clinical trial. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start1 Mar 2024
- Primary completion1 May 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal Cancer (CRC)Studies 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
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Niguarda Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Salvatore Siena, MD, Principal investigator, ASST Niguarda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07536113
- Sponsor's protocol ID
- 4855
- Acronym
- RealCHALLENGE
- Status last verified
- Apr 2026
- First submitted
- 8 Mar 2026
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: not yet decided
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Efficacy and Safety of ctDNA-driven Selection for Anti-EGFR Retreatment in a Real World Metastatic Colorectal Cancer Patients Cohort
- ClinicalTrials.gov ID
- NCT07536113
- Acronym / sponsor ID
- RealCHALLENGE / 4855
- Conditions
- Metastatic Colorectal Cancer (CRC)
- Keywords
- liquid biopsy, mCRC, rechallenge therapies, Anti-EGFR
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Niguarda HospitalUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 17 Apr 2026 (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 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.
Detailed description
Patient's data to be collected include: age, gender, ethnicity; Eastern Cooperative Oncology Group scale performance status (ECOGPS); date of first diagnosis and date of advanced CRC diagnosis; primary tumor histology; timing of collection of FFPE and liquid biopsy samples; molecular profile data both from archival solid tissue and liquid biopsy; number and sites of metastasis at the time of liquid biopsy draw; medical treatment regimens, lines and locoregional approaches pursued, focusing on the first treatment received by patients following ctDNA analysis; date of death or last follow up. Response evaluation to therapies have to be assessed according to Response Evaluation Criteria in solid tumors (RECIST v1.1) criteria. Information will be provided about resposne to standard treatments (RR and DCR), duration of response (DOR), progression-free survival (PFS), time-to-treatment failure (TTF), OS.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mCRC patients | – | –Patients diagnosed with mCRC and screened by ctDNA within the MEN1611-02 clinical trial. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with MSS RAS and BRAF wild-type (on solid tissue) mCRC
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Efficacy anti-EGFR rechallenge
Time frame: Up to two years
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Individual participant dataSharing planned: Undecided. not yet decided
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CRC
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.
Salvatore Siena, MD principal investigator
ASST Niguarda Hospital
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 Metastatic Colorectal Cancer (CRC), run by Niguarda Hospital at 1 site in Italy.
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 5 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 17 Apr 2026. 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Salvatore Siena, MD (+39026444 ext. 3695, salvatore.siena@ospedaleniguarda.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy anti-EGFR rechallenge (time frame: Up to two years). 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 17 Apr 2026.