Observing People With Desmoid-Type Fibromatosis
ConditionDesmoid Fibromatosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center
About this trial
The purpose of this study is to closely observe people with desmoid-type fibromatosis over 1 months.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Clinical diagnosis of desmoid fibromatosis, either new or newly recurrent. Both patients with sporadic and FAP-associated disease will be eligible for inclusion. Patients with clinical diagnosis of desmoid (as assessed by MSK physician) but without pathologic diagnosis may be enrolled on the study to facilitate acquisition of appropriately protocoled baseline scans and allow for biospecimen collection; these patients will be replaced for purposes of analysis if pathology does not confirm clinical diagnosis.
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
Disqualifiers
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
Trial population
In most cases, patients will be identified by primary care providers in sarcoma medical and surgical oncology clinics.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Cross-sectional imaging
Diagnostic testMRI 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.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Desmoid Fibromatosis1 intervention
Trial outcomes
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).
Time frame
12 monthsSponsors and contacts
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Source ClinicalTrials.gov