DesmoidNCT05091255
Cryotherapy in the Treatment of Desmoid Tumors
A study testing Cryotherapy in people with Desmoid, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
Desmoid tumor is a benign neoplasm with an unpredictable course and a high rate of local recurrence if treated surgically. Therefore, over time the surgical approach has become conservative, preferring simple observation or medical therapy in case of disease progression through the use of hormonal therapy and low-dose… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Desmoid
- What is being tested?
- Cryotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteItaly
- Study dates
- 20 May 2021to 1 Jan 2027
- Phase
- Interventional
- 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
Who may be able to join
- histologic diagnosis of desmoid tumors
- age > 18 years
- abdominal and extra-abdominal desmoid tumors
Who cannot join
- contraindication to the procedure by the interventional radiologist in terms of tumor proximity to neurologic/vascular structures
- retroperitoneal desmoid tumors
- age < 18 years
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
IRCCS Itituto Ortopedico Rizzoli
Bologna, BO, 40136
Costantino Errani, MD
About this study
Desmoid tumor is a benign neoplasm with an unpredictable course and a high rate of local recurrence if treated surgically. Therefore, over time the surgical approach has become conservative, preferring simple observation or medical therapy in case of disease progression through the use of hormonal therapy and low-dose chemotherapy. Since this neoplasm remains benign, our study aims to avoid chemotherapy in patients usually young through the use of a minimally invasive treatment such as cryotherapy.
- Conditions
- Desmoid
- Being tested
- Cryotherapy
- Keywords
- desmoid tumor; cryotherapy
- Medical subject headings
- Desmoid Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryotherapyProcedure or surgery
The procedure involves general or peripheral anesthesia and percutaneous treatment under CT control with probes capable of forming ice spheres of up to 3 cm that will be used in sufficient number to treat the neoplasm completely.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Experimental | Not described Receives: Procedure: Cryotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
response to treatment
assessment of tumor response to treatment will be performed using the solid tumor response criteria
Measured: At baseline (time 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2021
- Study start20 May 2021
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DesmoidStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Costantino Errani, Istituto Ortopedico Rizzoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05091255
- Sponsor's protocol ID
- CRYODESMO
- Status last verified
- Jul 2025
- First submitted
- 12 Oct 2021
- Last updated
- 1 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kujak JL, Liu PT, Johnson GB, Callstrom MR. Early experience with percutaneous cryoablation of extra-abdominal desmoid tumors. Skeletal Radiol. 2010 Feb;39(2):175-82. doi: 10.1007/s00256-009-0801-z. Epub 2009 Sep 21.
PubMed 19768644Redifer Tremblay K, Lea WB, Neilson JC, King DM, Tutton SM. Percutaneous cryoablation for the treatment of extra-abdominal desmoid tumors. J Surg Oncol. 2019 Sep;120(3):366-375. doi: 10.1002/jso.25597. Epub 2019 Jun 24.
PubMed 31236956Schmitz JJ, Schmit GD, Atwell TD, Callstrom MR, Kurup AN, Weisbrod AJ, Morris JM. Percutaneous Cryoablation of Extraabdominal Desmoid Tumors: A 10-Year Experience. AJR Am J Roentgenol. 2016 Jul;207(1):190-5. doi: 10.2214/AJR.15.14391. Epub 2016 Apr 11.
PubMed 27064168
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cryotherapy in the Treatment of Desmoid Tumors
- ClinicalTrials.gov ID
- NCT05091255
- Acronym / sponsor ID
- CRYODESMO
- Conditions
- Desmoid
- Keywords
- desmoid tumor; cryotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 20 May 2021 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 25 Oct 2021 (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.
Desmoid tumor is a benign neoplasm with an unpredictable course and a high rate of local recurrence if treated surgically. Therefore, over time the surgical approach has become conservative, preferring simple observation or medical therapy in case of disease progression through the use of hormonal therapy and low-dose chemotherapy. Since this neoplasm remains benign, our study aims to avoid chemotherapy in patients usually young through the use of a minimally invasive treatment such as cryotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Procedure: Cryotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- histologic diagnosis of desmoid tumors
- age > 18 years
- abdominal and extra-abdominal desmoid tumors
Key exclusion criteria (3 listed)
- contraindication to the procedure by the interventional radiologist in terms of tumor proximity to neurologic/vascular structures
- retroperitoneal desmoid tumors
- age < 18 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 |
|---|---|---|
| CryotherapyThe procedure involves general or peripheral anesthesia and percutaneous treatment under CT control with probes capable of forming ice spheres of up to 3 cm that will be used in sufficient number to treat the neoplasm completely. | Procedure or surgery | Patients |
Primary outcome
response to treatment
Time frame: At baseline (time 0)
assessment of tumor response to treatment will be performed using the solid tumor response 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 1 Aug 2025.
- Results publication: PubMed 19768644Kujak JL, Liu PT, Johnson GB, Callstrom MR. Early experience with percutaneous cryoablation of extra-abdominal desmoid tumors. Skeletal Radiol. 2010 Feb;39(2):175-82. doi: 10.1007/s00256-009-0801-z. Epub 2009 Sep 21.
- Results publication: PubMed 31236956Redifer Tremblay K, Lea WB, Neilson JC, King DM, Tutton SM. Percutaneous cryoablation for the treatment of extra-abdominal desmoid tumors. J Surg Oncol. 2019 Sep;120(3):366-375. doi: 10.1002/jso.25597. Epub 2019 Jun 24.
- Results publication: PubMed 27064168Schmitz JJ, Schmit GD, Atwell TD, Callstrom MR, Kurup AN, Weisbrod AJ, Morris JM. Percutaneous Cryoablation of Extraabdominal Desmoid Tumors: A 10-Year Experience. AJR Am J Roentgenol. 2016 Jul;207(1):190-5. doi: 10.2214/AJR.15.14391. Epub 2016 Apr 11.
- Individual participant dataSharing planned: No
Related trials for Desmoid
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryotherapy in people with Desmoid, run by Istituto Ortopedico Rizzoli 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 3 inclusion and 3 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 1 Aug 2025. 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 Costantino Errani, MD (051-6366 ext. 6103, costantino.errani@ior.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
response to treatment (time frame: At baseline (time 0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05091255, which also lists 3 linked publications.
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 1 Aug 2025.