Observing People With Desmoid-Type Fibromatosis
A Prospective Analysis of Active Observation in Patients With Desmoid-Type Fibromatosis
1 other identifier
observational
100
1 country
1
Brief Summary
The purpose of this study is to closely observe people with desmoid-type fibromatosis over 1 months.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2020
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 19, 2020
CompletedFirst Submitted
Initial submission to the registry
February 20, 2020
CompletedFirst Posted
Study publicly available on registry
February 24, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 19, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
February 19, 2026
CompletedMay 16, 2025
March 1, 2025
6 years
February 20, 2020
May 13, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression free survival
The primary objective of this study is to estimate progression-free survival at 12 months, with the events defined by progression via radiographic criteria (RECIST 1.1).
12 months
Study Arms (1)
Desmoid Fibromatosis
Participants will have a clinical diagnosis of desmoid fibromatosis, either new or newly recurrent
Interventions
MRI with gadolinium contrast will be the imaging modality of choice. In patients with contraindications to MRI who instead undergo baseline evaluation by CT scan, tumor evaluation will be by serial CT scans with IV contrast throughout the study period.
Eligibility Criteria
In most cases, patients will be identified by primary care providers in sarcoma medical and surgical oncology clinics.
You may qualify if:
- At least 18 years of age.
- Able to undergo cross-sectional imaging by either MRI or CT with intravenous contrast
- Disease detectable on cross-sectional imaging with target lesion measuring \>/= 1 cm
- Eligible for management by active observation as assessed by primary MSK care provider
- Willing and able to sign an informed consent document
You may not qualify if:
- Symptomatic desmoid fibromatosis requiring narcotic pain control, resulting in intestinal fistulization, or requiring inpatient admission during the 3 months prior to enrollment
- Patients with intraabdominal desmoids greater than 7cm in diameter or localized within 1cm of the central mesenteric vessels and those with tumors in the head and neck
- KPS performance status \</= 70 if performance status is limited due to tumor. Patients with low KPS performance status related to co-morbidities but without symptoms related to the tumor will be eligible for enrollment.
- Age less than 18 years old
- Strict contraindication for both cross-sectional MRI and CT imaging with intravenous contrast (e.g., as per standard institutional protocols regarding renal insufficiency or MRI incompatible implanted devices; patients requiring pre-medication to prevent contrast reactions will be eligible for study)
- Unable to grant reliable informed consent
- Ongoing systemic treatment for desmoid fibromatosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Aimee M Crago, MD, PhD
Memorial Sloan Kettering Cancer Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 20, 2020
First Posted
February 24, 2020
Study Start
February 19, 2020
Primary Completion
February 19, 2026
Study Completion
February 19, 2026
Last Updated
May 16, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will share
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.