Desmoid-Type FibromatosisNCT07496242
Immunological Phenotype of Desmoid-fibromatosis-affected Patients.
An observational study of Desmoid-Type Fibromatosis, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 8 sites in 2 countries.
Trial summary
This observational study aims to characterize the molecular, phenotypic, and functional inflammatory and immunological profile of patients with sporadic desmoid-type fibromatosis undergoing either active surveillance or systemic therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Desmoid-Type Fibromatosis
- How many people
- 200 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 27 May 2025to Dec 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 with primary sporadic desmoid-type fibromatosis with measurable disease under active surveillance * Patients with primary sporadic desmoid-type fibromatosis with measurable disease receiving systemic treatment.
Who may be able to join
- Patients with primary sporadic desmoid-type fibromatosis with measurable disease under active surveillance
- Patients with primary sporadic desmoid-type fibromatosis with measurable disease receiving systemic treatment.
Who cannot join
None listed.
Trial locations and contacts
8 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
8 sites in 2 countries
Italy7 sites, 7 recruiting
- Not yet recruiting
IRCCS Istituto di Candiolo Fondazione del Piemonte per l'Oncologia
Candiolo
Giovanni Grignani, MD, giovanni.grignani@ircc.it
Giovanni Grignani, MD
- Not yet recruiting
Azienda Ospedaliero Universitaria Careggi
Florence
Domenico Campanacci, MD, domenicoandrea.campanacci@unifi.it
Domenico Campanacci, MD
- Not yet recruiting
Azienda Usl Toscana centro
Florence
Giacomo Baldi, MD, giacomogiulio.baldi@uslcentro.toscana.it
Giacomo Baldi, MD
- Recruiting
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, 20133
Colombo Chiara, MD, Surgical oncologst, +390223902740, chiara.colombo@istitutotumori.mi.it
Chiara Colombo, MD, Surgical Oncologist
- Not yet recruiting
IRCCS Istituto Oncologico Veneto IOV
Padova
Antonella Brunello, MD, antonella.brunello@iov.veneto.it
Antonella Brunello, MD
- Not yet recruiting
Azienda Ospedaliera Universitaria Policlinico "Paolo Giaccone"
Palermo
Giuseppe Badalamenti, MD, giuseppe.badalamenti@unipa.it
Giuseppe Badalamenti, MD
- Not yet recruiting
Università Campus Bio-Medico
Rome
Bruno Vincenzi, MD, B.Vincenzi@policlinicocampus.it
Bruno Vincenzi, MD
Netherlands1 site, 1 recruiting
- Not yet recruiting
Erasmus University Medical Centre
Rotterdam
Stefanie Hakkesteegt, MD, s.hakkesteegt@erasmusmc.nl
Stefanie Hakkesteegt, MD
About this study
Official title: Immunological Profile of Patients With Desmoid-type Fibromatosis Under Active Surveillance.
This observational study aims to characterize the molecular, phenotypic, and functional inflammatory and immunological profile of patients with sporadic desmoid-type fibromatosis undergoing either active surveillance or systemic therapy. The study includes analysis of the tumor immune microenvironment (TIME), circulating immune and inflammatory molecules, immune cell subsets, and circulating tumor DNA (ctDNA). The goal is to identify biomarkers associated with spontaneous or treatment-induced tumor regression and to evaluate potential correlations with specific ß-catenin mutations.
- Conditions
- Desmoid-Type Fibromatosis
- Medical subject headings
- Desmoid Tumors
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 |
|---|---|---|
| Patients under active surveillance | Patients with primary sporadic desmoid-type fibromatosis with measurable disease | |
| Patients receiving systemic treatment | Patients with primary sporadic desmoid-type fibromatosis with measurable disease. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of circulating tumor DNA (ctDNA)
Quantification of circulating tumor DNA levels in peripheral blood samples to evaluate their association with the clinical course of the disease (stable disease, spontaneous regression, or progression according to RECIST criteria).
Measured: Baseline and every 3 months during the first year, then every 6 months up to 36 months.
Phenotypic profile of circulating immune cells
Characterization of circulating immune cell subsets in peripheral blood samples using immunophenotyping assays.
Measured: Baseline and every 3 months during the first year, then every 6 months up to 36 months.
Tumor immune microenvironment characteristics
Assessment of immune cell infiltration and inflammatory markers in available tumor biopsy samples to characterize the tumor immune microenvironment.
Measured: Baseline.
Clinical disease course
Clinical disease course assessed as stable disease, spontaneous regression, or progression according to RECIST criteria.
Measured: From baseline up to 36 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start27 May 2025
- Primary completion31 Aug 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Desmoid-Type FibromatosisStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoThe 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
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Campus Bio-Medico University, Candiolo Cancer Institute - IRCCS, Azienda Ospedaliero-Universitaria Careggi, Azienda USL Toscana Centro, Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo, Erasmus University Rotterdam, Istituto Oncologico Veneto IRCCS
- Responsible party
- Sponsor
- Investigators
- Chiara Colombo, MD, Surgical Oncologist, Principal investigator, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07496242
- Sponsor's protocol ID
- INT 90/18
- Status last verified
- Sep 2025
- First submitted
- 9 Dec 2025
- Last updated
- 27 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Aggregated clinical and molecular data generated from the study will be shared in scientific publications and presentations. These aggregated data will be made available after the publication of the main study results. Aggregated data will become available after publication of the primary results after the end of the study. Aggregated data will be available to researchers and clinicians through scientific publications and conference communications for scientific, educational, and research purposes, including further understanding of desmoid-type fibromatosis biology and clinical behavior. Data will be shared through peer-reviewed publications, conference presentations, and other scientific dissemination channels.
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunological Profile of Patients With Desmoid-type Fibromatosis Under Active Surveillance.
- ClinicalTrials.gov ID
- NCT07496242
- Acronym / sponsor ID
- INT 90/18
- Conditions
- Desmoid-Type Fibromatosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoUniversity, hospital or other
- Collaborators
- Campus Bio-Medico University, Candiolo Cancer Institute - IRCCS, Azienda Ospedaliero-Universitaria Careggi, Azienda USL Toscana Centro, Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo, Erasmus University Rotterdam, Istituto Oncologico Veneto IRCCS
- Study start
- 27 May 2025 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 27 Mar 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 observational study aims to characterize the molecular, phenotypic, and functional inflammatory and immunological profile of patients with sporadic desmoid-type fibromatosis undergoing either active surveillance or systemic therapy. The study includes analysis of the tumor immune microenvironment (TIME), circulating immune and inflammatory molecules, immune cell subsets, and circulating tumor DNA (ctDNA). The goal is to identify biomarkers associated with spontaneous or treatment-induced tumor regression and to evaluate potential correlations with specific ß-catenin mutations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients under active surveillance | – | –Patients with primary sporadic desmoid-type fibromatosis with measurable disease |
| Patients receiving systemic treatment | – | –Patients with primary sporadic desmoid-type fibromatosis with measurable disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * Patients with primary sporadic desmoid-type fibromatosis with measurable disease under active surveillance * Patients with primary sporadic desmoid-type fibromatosis with measurable disease receiving systemic treatment.
Key inclusion criteria (2 listed)
- Patients with primary sporadic desmoid-type fibromatosis with measurable disease under active surveillance
- Patients with primary sporadic desmoid-type fibromatosis with measurable disease receiving systemic treatment.
Key exclusion criteria (0 listed)
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
Levels of circulating tumor DNA (ctDNA)
Time frame: Baseline and every 3 months during the first year, then every 6 months up to 36 months.
Quantification of circulating tumor DNA levels in peripheral blood samples to evaluate their association with the clinical course of the disease (stable disease, spontaneous regression, or progression according to RECIST criteria).
Phenotypic profile of circulating immune cells
Time frame: Baseline and every 3 months during the first year, then every 6 months up to 36 months.
Characterization of circulating immune cell subsets in peripheral blood samples using immunophenotyping assays.
Tumor immune microenvironment characteristics
Time frame: Baseline.
Assessment of immune cell infiltration and inflammatory markers in available tumor biopsy samples to characterize the tumor immune microenvironment.
Clinical disease course
Time frame: From baseline up to 36 months.
Clinical disease course assessed as stable disease, spontaneous regression, or progression according to RECIST criteria.
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 27 Mar 2026.
- Individual participant dataSharing planned: Yes. Aggregated clinical and molecular data generated from the study will be shared in scientific publications and presentations. These aggregated data will be made available after the publication of the main study results. Aggregated data will become available after publication of the primary results after the end of the study. Aggregated data will be available to researchers and clinicians through scientific publications and conference communications for scientific, educational, and research purposes, including further understanding of desmoid-type fibromatosis biology and clinical behavior. Data will be shared through peer-reviewed publications, conference presentations, and other scientific dissemination channels.
Related trials for Desmoid-Type Fibromatosis
RecruitingPhase 2
A Study in Adults With Desmoid Tumors
Desmoid Tumor
RecruitingPhase 4
Nirogacestat in Premenopausal Females With Desmoid Tumor/Aggressive Fibromatosis (DT/AF)
Desmoid Tumor, Aggressive Fibromatosis
RecruitingPhase 1/2
FOG-001 in Locally Advanced or Metastatic Solid Tumors
Cancer, Colorectal Cancer
Active, not recruitingPhase 2
A Study of a New Drug, Nirogacestat, for Treating Desmoid Tumors That Cannot be Removed by Surgery
Desmoid Fibromatosis, Recurrent Desmoid Fibromatosis
Enrolling by invitationObservational study
Patient-reported Outcomes Following Percutaneous Ablation of Desmoid Tumors
Desmoid Tumor, Aggressive Fibromatoses
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.
Chiara Colombo, MD, Surgical Oncologist principal investigator
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Desmoid-Type Fibromatosis, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 8 sites in 2 countries.
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 2 inclusion and 0 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 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Italy, Netherlands. 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 Chiara Colombo, MD, Surgical Oncologist (+390223902740, chiara.colombo@istitutotumori.mi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Levels of circulating tumor DNA (ctDNA) (time frame: Baseline and every 3 months during the first year, then every 6 months up to 36 months.). The study lists 4 primary outcomes in all. 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 27 Mar 2026.