Desmoid TumorsCARDTNCT06113094
Cryoablation for Advanced and Refractory Desmoid Tumors
An observational study of Desmoid Tumors, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Desmoid tumors, also called aggressive fibromatosis, are rare, locally invasive tumors with no potential for metastasis. The incidence is approximately 2 to 4 per million per year in the general population. The "watch and wait" policy is the standard of care for newly diagnosed patients in Europe. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Desmoid Tumors
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 7 Jul 2020to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 patient (≥18 years old) having undergone cryoablation for an advanced desmoid tumor refractory to medical treatment
Who may be able to join
- Adult patient (≥18 years old)
- Having undergone cryoablation for an advanced desmoid tumor refractory to medical treatment
- Having not expressed their opposition, after being informed, to the reuse of their data for the purposes of this research.
Who cannot join
- Subject who expressed their opposition to participating in the study
- Patient already included in another ongoing study
- Subject under guardianship or curatorship
- Subject under safeguard of justice
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service d'Imagerie Interventionnelle - CHU de Strasbourg - France
Strasbourg, 67091
Pierre AULOGE, MD, 33 3 69 55 15 26, pierre.auloge@chru-strasbourg.fr
Pierre AULOGE, MD
About this study
Desmoid tumors, also called aggressive fibromatosis, are rare, locally invasive tumors with no potential for metastasis. The incidence is approximately 2 to 4 per million per year in the general population. The "watch and wait" policy is the standard of care for newly diagnosed patients in Europe. Patients who progress have first-line medical treatment, surgery is no longer the treatment because there is a high rate of recurrence (> 60%) and radiotherapy is not very suitable because the patients are often young and the tumors are large. Cryoablation seems to be an effective therapeutic option that should be evaluated.
- Conditions
- Desmoid Tumors
- Keywords
- Desmoid tumors, Fibromatosis, Invasive tumors, Radiotherapy, Cryoablation
- Medical subject headings
- Desmoid Tumors, Fibroma
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival assessed using RECIST(Response evaluation criteria in solid tumors) criteria
Measured: at 6 months after cryoablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start7 Jul 2020
- Primary completionDec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Desmoid TumorsStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06113094
- Sponsor's protocol ID
- 7884
- Acronym
- CARDT
- Status last verified
- Nov 2022
- First submitted
- 14 Nov 2022
- Last updated
- 2 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cryoablation for Advanced and Refractory Desmoid Tumors
- ClinicalTrials.gov ID
- NCT06113094
- Acronym / sponsor ID
- CARDT / 7884
- Conditions
- Desmoid Tumors
- Keywords
- Desmoid tumors, Fibromatosis, Invasive tumors, Radiotherapy, Cryoablation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 7 Jul 2020 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 2 Nov 2023 (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 tumors, also called aggressive fibromatosis, are rare, locally invasive tumors with no potential for metastasis. The incidence is approximately 2 to 4 per million per year in the general population. The "watch and wait" policy is the standard of care for newly diagnosed patients in Europe. Patients who progress have first-line medical treatment, surgery is no longer the treatment because there is a high rate of recurrence (> 60%) and radiotherapy is not very suitable because the patients are often young and the tumors are large. Cryoablation seems to be an effective therapeutic option that should be evaluated.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patient (≥18 years old) having undergone cryoablation for an advanced desmoid tumor refractory to medical treatment
Key inclusion criteria (3 listed)
- Adult patient (≥18 years old)
- Having undergone cryoablation for an advanced desmoid tumor refractory to medical treatment
- Having not expressed their opposition, after being informed, to the reuse of their data for the purposes of this research.
Key exclusion criteria (4 listed)
- Subject who expressed their opposition to participating in the study
- Patient already included in another ongoing study
- Subject under guardianship or curatorship
- Subject under safeguard of justice
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
Progression-free survival assessed using RECIST(Response evaluation criteria in solid tumors) criteria
Time frame: at 6 months after cryoablation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2023.
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FOG-001 in Locally Advanced or Metastatic Solid Tumors
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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
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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. This study is not recruiting at the moment.
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 Desmoid Tumors, run by University Hospital, Strasbourg, France at 1 site in France.
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 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: status not confirmed, as of the sponsor's last update on 2 Nov 2023. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pierre AULOGE, MD (33 3 69 55 15 26, pierre.auloge@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival assessed using RECIST(Response evaluation criteria in solid tumors) criteria (time frame: at 6 months after cryoablation). 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 2 Nov 2023.