Clinical Trials Logo

Clinical Trial Summary

Rationale: Desmoid-type fibromatosis (DTF) is a rare, histologically benign, soft tissue tumour. Although incapable of metastasizing, the clinical course is unpredictable and can be aggressive because of local invasive growth. Various treatments are available including; surgical resection, radiotherapy, hormonal therapy and chemotherapy. Nowadays there is a trend towards a more conservative strategy with a wait and see policy because of high recurrence rates after surgical resection. Health-related quality of life (HRQL) is a corner stone in treatment choice and can be used during the disease for monitoring the impact of the disease on physical, psychological and social level. Additionally, HRQL can be in important endpoint for future clinical trials. Today, no HRQL-tools are available which capture the needs of DTF patients. The hypothesis is that patients with DTF have issues on several HRQL domains including physical, social and emotional well-being. For this reason we developed a list of items based on previous research. This study aims to evaluate HRQL issues experienced by DTF patients. Purpose: Multi-centre, cross-sectional, observational study to measure HRQL of DTF patients and to evaluate the prevalence of the experienced problems.


Clinical Trial Description

Objectives: The primary objective is to evaluate HRQoL problems in adult DTF patients. The secondary objectives are: 1) to compare the level of HRQoL of DTF patients to the general population, 2) to identify patient subgroups who are at risk for developing certain HRQoL problems, 3) to evaluate patient preferences regarding their health care needs for DTF. Outline: All patients, aged above 18 years, with a histopathological proved DTF tumour and sufficient Dutch language skills who have received their last check-up in the hospital within the last five years (April 2014). Patients treated in one of the participating centres, will be asked to fill out a set of questionnaires (baseline questionnaire, health care utilization, decision making, EORTC QLQ-C30, DTF-specific questionnaire, and the EQ-5D-5L). Patients will only have to fill out these questionnaires once. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04289077
Study type Observational
Source Erasmus Medical Center
Contact
Status Completed
Phase
Start date August 6, 2020
Completion date February 1, 2021

See also
  Status Clinical Trial Phase
Recruiting NCT05561036 - A Randomized, Double-blind,Phase Ⅲ Study of Liposome Doxorubicin in Desmoid Tumor Phase 3
Completed NCT00287846 - Imatinib Mesylate in Treating Patients With Recurrent or Refractory Fibromatosis Phase 1/Phase 2
Recruiting NCT06258421 - Burden of Disease and Living Situation in Desmoid Patients
Completed NCT00030680 - Radiation Therapy in Treating Patients With Aggressive Fibromatoses Phase 2
Recruiting NCT06081400 - Cryoablation Versus Medical Therapy in Desmoid Tumors Progressing After Watchful Waiting N/A
Active, not recruiting NCT04871282 - A Study of AL102 in Patients With Progressing Desmoid Tumors Phase 2/Phase 3
Recruiting NCT01567046 - Studying Genes in Tissue Samples From Younger and Adolescent Patients With Soft Tissue Sarcomas N/A
Completed NCT01137916 - Study to Evaluate Imatinib in Desmoid Tumors Phase 2
Completed NCT00002595 - Toremifene in Treating Patients With Desmoid Tumors Phase 2
Completed NCT03459469 - Phase I, Open-label, Non-randomized Study to Evaluate Safety of BC2059 Phase 1
Completed NCT06195085 - CT-guided Radioactive Iodine-125 Seed Implantation for Recurrent Desmoid Tumors
Completed NCT01286662 - A Cohort Study of Patients Treated With Brachytherapy for Selected Desmoid Patients in Gardner Syndrome N/A
Completed NCT01265030 - A Pilot Study Evaluating the Use of mTor Inhibitor Sirolimus in Children and Young Adults With Desmoid-Type Fibromatosis Phase 1/Phase 2
Completed NCT00068419 - Sulindac and Tamoxifen in Treating Patients With Desmoid Tumor Phase 2
Completed NCT03190174 - Nivolumab (Opdivo®) Plus ABI-009 (Nab-rapamycin) for Advanced Sarcoma and Certain Cancers Phase 1/Phase 2
Completed NCT00003019 - Vinblastine and Methotrexate in Treating Children With Desmoid Tumors Phase 2
Recruiting NCT05949099 - Study of Cryoablation and Nirogacestat for Desmoid Tumor Phase 2
Active, not recruiting NCT02076906 - MR-guided High Intensity Focused Ultrasound (HIFU) on Pediatric Solid Tumors Phase 1
Completed NCT00474994 - Sunitinib in Treating Patients With Metastatic, Locally Advanced, or Locally Recurrent Sarcomas Phase 2
Active, not recruiting NCT03785964 - Nirogacestat for Adults With Desmoid Tumor/Aggressive Fibromatosis (DT/AF) Phase 3