Clinical trial NCT04281381: Observing People With Desmoid-Type Fibromatosis
Official title: A Prospective Analysis of Active Observation in Patients With Desmoid-Type Fibromatosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Desmoid Fibromatosis
Keywords: Desmoid-Type Fibromatosis
Desmoid Fibromatosis
Desmoid
Fibromatosis
20-026
Memorial Sloan Kettering Cancer Center
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2020-02-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: In most cases, patients will be identified by primary care providers in sarcoma medical and surgical oncology clinics.

Brief summary: The purpose of this study is to closely observe people with desmoid-type fibromatosis over 1 months.


Eligibility criteria: Inclusion Criteria:

* 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
* Eligible for management by active observation as assessed by primary MSK care provider
* Willing and able to sign an informed consent document

Exclusion Criteria:

* 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

Primary outcomes:
measure: Progression free survival
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Aimee M Crago, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: