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Trial Title:
Burden of Disease and Living Situation in Desmoid Patients
NCT ID:
NCT06258421
Condition:
Desmoid Tumor
Quality of Life
Conditions: Official terms:
Fibromatosis, Aggressive
Conditions: Keywords:
Health-related Quality of Life
Unmet needs
Return to normal life
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
No Intervention
Description:
Observatory Study
Arm group label:
Desmoid Tumor Patients
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).
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Desmoid diagnosis (primary neoplasia, all stages)
- Age ≥18 years at diagnosis
Exclusion Criteria:
- Inability to complete a structured questionnaire (insufficient language skills;
dementia)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Universitätsklinikum Carl-Gustav-Carus Dresden
Address:
City:
Dresden
Zip:
01307
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Martin Eichler, M.Sc. / PHD
Phone:
+49351458 19057
Email:
martin.eichler@ukdd.de
Investigator:
Last name:
Martin Eichler, PhD
Email:
Principal Investigator
Start date:
October 1, 2023
Completion date:
December 2024
Lead sponsor:
Agency:
Technische Universität Dresden
Agency class:
Other
Collaborator:
Agency:
SOS Desmoid e.V.
Agency class:
Other
Collaborator:
Agency:
Universitätsmedizin Mannheim
Agency class:
Other
Source:
Technische Universität Dresden
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06258421
