Desmoid TumorPROSa DesmoidNCT06258421
Burden of Disease and Living Situation in Desmoid Patients
An observational study of Desmoid Tumor and Quality of Life, run by Technische Universität Dresden at 1 site in Germany.
Trial summary
The main aim of the study is to assess the situation and quality of life of desmoid patients. Impaired areas of quality of life and the associated factors are to be identified. The survey is planned as a cross-sectional study (patient survey). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Desmoid Tumor, Quality of Life
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 1 Oct 2023to 1 Sep 2024
- 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: People who have been diagnosed with a desmoid tumorafter the age of 18. Treatment at the Mannheim University Hospital or via SOS Desmoid e.V.
Who may be able to join
- Desmoid diagnosis (primary neoplasia, all stages)
- Age ≥18 years at diagnosis
Who cannot join
- Inability to complete a structured questionnaire (insufficient language skills; dementia)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Universitätsklinikum Carl-Gustav-Carus Dresden
Dresden, Saxony, 01307
About this study
The main aim of the study is to assess the situation and quality of life of desmoid patients. Impaired areas of quality of life and the associated factors are to be identified. The survey is planned as a cross-sectional study (patient survey).
Prevalent and incident desmoid patients will be identified at the University Hospital Mannheim and checked for eligibility. Quality of life and patient-reported data are collected by means of written questionnaires. Medical data is collected from patient files in the clinics. The aim is to include 100 patients. Descriptive analyses of the variables collected and regression models are planned as statistical analysis.
- Conditions
- Desmoid Tumor, Quality of Life
- Being tested
- No Intervention
- Keywords
- Health-related Quality of Life, Unmet needs, Return to normal life
- Medical subject headings
- Desmoid Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
Observatory Study
| Study group | Role | What they receive |
|---|---|---|
| Desmoid Tumor Patients | People who have been diagnosed with a desmoid tumor after the age of 18 Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-related Quality of Life (EORTC C30)
Health-Related Quality of Life Questionnaire
Measured: baseline
Secondary outcomes (3)
The Brief Pain Inventory (BPI)
The BPI scale defines pain as follows: Worst Pain Score: 1 - 4 = Mild Pain. Worst Pain Score: 5 - 6 = Moderate Pain. Worst Pain Score: 7 - 10 = Severe Pain.
Measured: baseline
Reintegration to Normal Living (RNL) Index
Reintegration to normal living as a proxy to quality of life
Measured: baseline
Supportive Care Needs Survey
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start1 Oct 2023
- Primary completion31 Aug 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Desmoid TumorStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe 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
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Collaborators
- SOS Desmoid e.V., Universitätsmedizin Mannheim
- Responsible party
- Sponsor
- Investigators
- Martin Eichler, Dr., M.Sc. / PHD, Principal investigator, Universitätsklinikum Carl-Gustav-Carus Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06258421
- Sponsor's protocol ID
- SR+BO-EK-388092023
- Acronym
- PROSa Desmoid
- Status last verified
- Feb 2024
- First submitted
- 24 Jan 2024
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Burden of Disease and Living Situation in Desmoid Patients
- ClinicalTrials.gov ID
- NCT06258421
- Acronym / sponsor ID
- PROSa Desmoid / SR+BO-EK-388092023
- Conditions
- Desmoid Tumor, Quality of Life
- Keywords
- Health-related Quality of Life, Unmet needs, Return to normal life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Collaborators
- SOS Desmoid e.V., Universitätsmedizin Mannheim
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 14 Feb 2024 (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 main aim of the study is to assess the situation and quality of life of desmoid patients. Impaired areas of quality of life and the associated factors are to be identified. The survey is planned as a cross-sectional study (patient survey).
Prevalent and incident desmoid patients will be identified at the University Hospital Mannheim and checked for eligibility. Quality of life and patient-reported data are collected by means of written questionnaires. Medical data is collected from patient files in the clinics. The aim is to include 100 patients. Descriptive analyses of the variables collected and regression models are planned as statistical analysis.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Desmoid Tumor Patients | – | Other: No InterventionPeople who have been diagnosed with a desmoid tumor after the age of 18 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People who have been diagnosed with a desmoid tumorafter the age of 18. Treatment at the Mannheim University Hospital or via SOS Desmoid e.V.
Key inclusion criteria (2 listed)
- Desmoid diagnosis (primary neoplasia, all stages)
- Age ≥18 years at diagnosis
Key exclusion criteria (1 listed)
- Inability to complete a structured questionnaire (insufficient language skills; dementia)
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 |
|---|---|---|
| No InterventionObservatory Study | Other | Desmoid Tumor Patients |
Primary outcome
Health-related Quality of Life (EORTC C30)
Time frame: baseline
Health-Related Quality of Life Questionnaire
3 secondary outcomes
The Brief Pain Inventory (BPI)
Time frame: baseline
Reintegration to Normal Living (RNL) Index
Time frame: baseline
Supportive Care Needs Survey
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for Desmoid Tumor
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. This study is not recruiting at the moment.
Martin Eichler, Dr., M.Sc. / PHD principal investigator
Universitätsklinikum Carl-Gustav-Carus Dresden
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 Tumor and Quality of Life, run by Technische Universität Dresden at 1 site in Germany.
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 1 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: finished, as of the sponsor's last update on 24 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health-related Quality of Life (EORTC C30) (time frame: baseline). 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 24 Aug 2025.