Colo-rectal CancerRaP-DMac-LiMeNCT07744139
Radiogenomic Profiling of Dendritic Cells and Macrophages to Predict Recurrence in Colorectal Liver Metastasis
An observational study of Colo-rectal Cancer and Liver Metastases, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
Trial summary
The RaP-DMac-LiMe study (Radiogenomic Profiling of Dendritic Cells and Macrophages to Predict Recurrence in Colorectal Liver Metastasis) is a monocentric, non-profit observational study promoted by Fondazione Policlinico Universitario A. Gemelli IRCCS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colo-rectal Cancer, Liver Metastases, Colon Cancer
- What is being tested?
- Radiogenomic and Immune Profiling and Prospective Radiogenomic and ctDNA Profiling
- How many people
- 210 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 31 Dec 2029
- How long will I take part?
- 24 Months
- 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: Adult patients with metastatic colorectal cancer and histologically confirmed colorectal liver metastases undergoing standard clinical management and curative-intent liver resection at Fondazione Policlinico Universitario A. Gemelli IRCCS. The study includes both a retrospective cohort with available tumour tissue and clinical data and a prospective cohort undergoing collection of tumour tissue and peripheral blood samples during routine clinical care
Who may be able to join
- Age ≥18 years.
- Histologically confirmed colorectal liver metastases.
- Administration of neoadjuvant chemotherapy prior to liver resection, with objective tumour response classified as partial response (PR) or stable disease (SD) according to RECIST criteria.
- Availability of a hepatobiliary contrast-enhanced MRI performed within 2 months before surgery.
- Provision of informed consent for prospectively enrolled participants, or eligibility under Article 110-bis of the Italian Privacy Code for retrospectively enrolled participants.
Who cannot join
- Recurrent metastatic disease.
- Liver resection performed with non-curative intent.
- Current or previous hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
- Concomitant malignancies or history of another malignancy treated within the previous 5 years.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The RaP-DMac-LiMe study (Radiogenomic Profiling of Dendritic Cells and Macrophages to Predict Recurrence in Colorectal Liver Metastasis) is a monocentric, non-profit observational study promoted by Fondazione Policlinico Universitario A. Gemelli IRCCS. Its primary aim is to identify immunological, genomic, and radiomic biomarkers associated with recurrence risk in patients with colorectal liver metastases (CRLM) undergoing curative-intent liver resection.
The study is based on the need to improve prognostic stratification in CRLM by integrating information from the tumor immune microenvironment, tumor genomics, radiomics, and clinical data. Particular attention is given to myeloid immune cells, especially dendritic cells and tumor-associated macrophages, whose role in metastatic progression and recurrence remains insufficiently understood.
Read more
The primary objective is to assess the association between myeloid immune profiles and recurrence risk through integrated molecular, spatial, genomic, and radiological analyses. Secondary objectives include characterizing the transcriptomic and genomic features of dendritic cells and macrophages, identifying radiomic and circulating tumor DNA (ctDNA) biomarkers, and evaluating their potential as non-invasive tools for recurrence prediction and patient stratification.
The study includes a retrospective cohort of approximately 160 patients treated between 2009 and 2023 and a prospective cohort of approximately 50 patients who will be followed for 24 months. Tumor tissue samples, peripheral blood, imaging data (CT/MRI), and clinical information collected during routine care will be analyzed without introducing any experimental interventions or deviations from standard clinical practice.
Analyses will include transcriptomic profiling, multiplex spatial characterization of immune cells, circulating tumor DNA sequencing using next-generation sequencing technologies, radiomic feature extraction, and integration of all data using statistical and machine learning approaches. Predictive models will be trained on retrospective data and independently validated in the prospective cohort.
The primary endpoint is the prediction of colorectal liver metastasis recurrence within two years after liver resection. Ultimately, the study aims to develop and validate a multimodal predictive model integrating immune, genomic, radiomic, and clinical variables to improve recurrence risk assessment and support personalized patient management.
The overall study duration is 36 months. All procedures will be conducted in accordance with ethical standards and data protection regulations, with samples and clinical data pseudonymized and handled in compliance with the GDPR.
- Conditions
- Colo-rectal Cancer, Liver Metastases, Colon Cancer
- Being tested
- Radiogenomic and Immune Profiling, Prospective Radiogenomic and ctDNA Profiling
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiogenomic and Immune ProfilingOther
Analysis of tumour tissue, radiological images, and clinical data collected during routine clinical care. Molecular, genomic, spatial, transcriptomic, and radiomic profiling will be performed to investigate associations with recurrence risk and clinical outcomes in patients with colorectal liver metastases. No investigational drugs, devices, or experimental procedures are administered as part of the study.
Prospective Radiogenomic and ctDNA ProfilingOther
Patients with histologically confirmed colorectal liver metastases undergoing standard clinical management and curative-intent liver resection, enrolled prospectively with collection of tumour tissue and peripheral blood samples. Prospective collection and analysis of tumour tissue, peripheral blood-derived ctDNA, radiological, genomic, immune and clinical data.
| Study group | Role | What they receive |
|---|---|---|
| Retrospective CRLM Cohort | Patients with histologically confirmed colorectal liver metastases who underwent curative-intent liver resection between January 2009 and December 2023 and for whom tumour tissue and clinical data are available. Retrospective collection and analysis of tumour tissue, radiological, genomic, immune and clinical data. Receives: Other: Radiogenomic and Immune Profiling | |
| Prospective CRLM Cohort | Patients with histologically confirmed colorectal liver metastases undergoing standard clinical management and curative-intent liver resection, enrolled prospectively with collection of tumour tissue and peripheral blood samples. Prospective collection and analysis of tumour tissue, peripheral blood-derived ctDNA, radiological, genomic, immune and clinical data. Receives: Other: Prospective Radiogenomic and ctDNA Profiling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prediction of Colorectal Liver Metastasis Recurrence
Prediction of colorectal liver metastasis recurrence following curative-intent liver resection using an integrated model based on radiogenomic, immune, and clinical profiling. Recurrence will be assessed through routine clinical follow-up and radiological evaluation.
Measured: 24 Months after liver resection
Secondary outcomes (4)
Correlation Between Myeloid Immune Cell Frequencies and Clinical Outcome Measures
Correlation between dendritic cell and tumor-associated macrophage frequencies (% of CD45⁺ immune cells), measured by multiparametric flow cytometry, and overall survival (months), relapse-free survival (months), and recurrence status (yes/no).
Measured: Up to 24 Months after liver resection
Genomic Alterations Associated With Immune Landscape Patterns
Identification of tumour-associated genetic alterations correlated with specific immune microenvironment profiles in colorectal liver metastases.
Measured: Baseline (analysis of collected tumour tissue and ctDNA samples)
Radiomic Features Associated With Immune Cell Distribution
Identification of radiomic features associated with the distribution and characteristics of dendritic cells and tumour-associated macrophages within tumour tissues.
Measured: Baseline (pre-operative MRI/CT imaging)
Performance of the Machine Learning-Based Recurrence Prediction Model
Development and validation of a machine learning-based model for recurrence risk prediction. Model performance will be assessed using area under the receiver operating characteristic curve (AUC), sensitivity, specificity, positive predictive value, and negative predictive value.
Measured: Up to 24 Months after liver resection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Sep 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colo-rectal CancerStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- 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
- 210 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Famularo Simone, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- Simone Famularo, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07744139
- Sponsor's protocol ID
- 27482
- Acronym
- RaP-DMac-LiMe
- Status last verified
- Aug 2026
- First submitted
- 29 Jul 2026
- Last updated
- 6 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiogenomic Profiling of Dendritic Cells and Macrophages to Predict Recurrence in Colorectal Liver Metastasis
- ClinicalTrials.gov ID
- NCT07744139
- Acronym / sponsor ID
- RaP-DMac-LiMe / 27482
- Conditions
- Colo-rectal Cancer, Liver Metastases, Colon Cancer
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Sep 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 4 Aug 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.
The RaP-DMac-LiMe study (Radiogenomic Profiling of Dendritic Cells and Macrophages to Predict Recurrence in Colorectal Liver Metastasis) is a monocentric, non-profit observational study promoted by Fondazione Policlinico Universitario A. Gemelli IRCCS. Its primary aim is to identify immunological, genomic, and radiomic biomarkers associated with recurrence risk in patients with colorectal liver metastases (CRLM) undergoing curative-intent liver resection.
The study is based on the need to improve prognostic stratification in CRLM by integrating information from the tumor immune microenvironment, tumor genomics, radiomics, and clinical data. Particular attention is given to myeloid immune cells, especially dendritic cells and tumor-associated macrophages, whose role in metastatic progression and recurrence remains insufficiently understood.
The primary objective is to assess the association between myeloid immune profiles and recurrence risk through integrated molecular, spatial, genomic, and radiological analyses. Secondary objectives include characterizing the transcriptomic and genomic features of dendritic cells and macrophages, identifying radiomic and circulating tumor DNA (ctDNA) biomarkers, and evaluating their potential as non-invasive tools for recurrence prediction and patient stratification.
The study includes a retrospective cohort of approximately 160 patients treated between 2009 and 2023 and a prospective cohort of approximately 50 patients who will be followed for 24 months. Tumor tissue samples, peripheral blood, imaging data (CT/MRI), and clinical information collected during routine care will be analyzed without introducing any experimental interventions or deviations from standard clinical practice.
Analyses will include transcriptomic profiling, multiplex spatial characterization of immune cells, circulating tumor DNA sequencing using next-generation sequencing technologies, radiomic feature extraction, and integration of all data using statistical and machine learning approaches. Predictive models will be trained on retrospective data and independently validated in the prospective cohort.
The primary endpoint is the prediction of colorectal liver metastasis recurrence within two years after liver resection. Ultimately, the study aims to develop and validate a multimodal predictive model integrating immune, genomic, radiomic, and clinical variables to improve recurrence risk assessment and support personalized patient management.
The overall study duration is 36 months. All procedures will be conducted in accordance with ethical standards and data protection regulations, with samples and clinical data pseudonymized and handled in compliance with the GDPR.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective CRLM Cohort | – | Other: Radiogenomic and Immune ProfilingPatients with histologically confirmed colorectal liver metastases who underwent curative-intent liver resection between January 2009 and December 2023 and for whom tumour tissue and clinical data are available. Retrospective collection and analysis of tumour tissue, radiological, genomic, immune and clinical data. |
| Prospective CRLM Cohort | – | Other: Prospective Radiogenomic and ctDNA ProfilingPatients with histologically confirmed colorectal liver metastases undergoing standard clinical management and curative-intent liver resection, enrolled prospectively with collection of tumour tissue and peripheral blood samples. Prospective collection and analysis of tumour tissue, peripheral blood-derived ctDNA, radiological, genomic, immune and clinical data. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with metastatic colorectal cancer and histologically confirmed colorectal liver metastases undergoing standard clinical management and curative-intent liver resection at Fondazione Policlinico Universitario A. Gemelli IRCCS. The study includes both a retrospective cohort with available tumour tissue and clinical data and a prospective cohort undergoing collection of tumour tissue and peripheral blood samples during routine clinical care
Key inclusion criteria (5 listed)
- Age ≥18 years.
- Histologically confirmed colorectal liver metastases.
- Administration of neoadjuvant chemotherapy prior to liver resection, with objective tumour response classified as partial response (PR) or stable disease (SD) according to RECIST criteria.
- Availability of a hepatobiliary contrast-enhanced MRI performed within 2 months before surgery.
- Provision of informed consent for prospectively enrolled participants, or eligibility under Article 110-bis of the Italian Privacy Code for retrospectively enrolled participants.
Key exclusion criteria (4 listed)
- Recurrent metastatic disease.
- Liver resection performed with non-curative intent.
- Current or previous hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
- Concomitant malignancies or history of another malignancy treated within the previous 5 years.
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 |
|---|---|---|
| Radiogenomic and Immune ProfilingAnalysis of tumour tissue, radiological images, and clinical data collected during routine clinical care. Molecular, genomic, spatial, transcriptomic, and radiomic profiling will be performed to investigate associations with recurrence risk and clinical outcomes in patients with colorectal liver metastases. No investigational drugs, devices, or experimental procedures are administered as part of the study. | Other | Retrospective CRLM Cohort |
| Prospective Radiogenomic and ctDNA ProfilingPatients with histologically confirmed colorectal liver metastases undergoing standard clinical management and curative-intent liver resection, enrolled prospectively with collection of tumour tissue and peripheral blood samples. Prospective collection and analysis of tumour tissue, peripheral blood-derived ctDNA, radiological, genomic, immune and clinical data. | Other | Prospective CRLM Cohort |
Primary outcome
Prediction of Colorectal Liver Metastasis Recurrence
Time frame: 24 Months after liver resection
Prediction of colorectal liver metastasis recurrence following curative-intent liver resection using an integrated model based on radiogenomic, immune, and clinical profiling. Recurrence will be assessed through routine clinical follow-up and radiological evaluation.
4 secondary outcomes
Correlation Between Myeloid Immune Cell Frequencies and Clinical Outcome Measures
Time frame: Up to 24 Months after liver resection
Genomic Alterations Associated With Immune Landscape Patterns
Time frame: Baseline (analysis of collected tumour tissue and ctDNA samples)
Radiomic Features Associated With Immune Cell Distribution
Time frame: Baseline (pre-operative MRI/CT imaging)
Performance of the Machine Learning-Based Recurrence Prediction Model
Time frame: Up to 24 Months after liver resection
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 6 Aug 2026.
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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.
Simone Famularo principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Questions about this trial
What is this clinical trial studying?
An observational study of Colo-rectal Cancer and Liver Metastases, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
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 4 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: opening soon, as of the sponsor's last update on 6 Aug 2026. 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?
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 Simone Famularo, MD (+390630155626, simone.famularo@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prediction of Colorectal Liver Metastasis Recurrence (time frame: 24 Months after liver resection). 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 6 Aug 2026.