Observing patients with desmoid-type fibromatosis
A Prospective Analysis of Active Observation in Patients With Desmoid-Type Fibromatosis
This study is tracking people with desmoid-type fibromatosis for a month to see how their condition changes using imaging tests and samples.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT04281381 on ClinicalTrials.gov |
What this trial studies
This observational study aims to closely monitor individuals diagnosed with desmoid-type fibromatosis for a duration of one month. Participants will undergo cross-sectional imaging, such as MRI or CT scans, to assess their condition. The study includes both newly diagnosed and recurrent cases, allowing for the collection of baseline scans and biospecimens. The goal is to gather detailed information about the disease's progression and characteristics.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a clinical diagnosis of desmoid fibromatosis that is detectable on imaging.
Not a fit: Patients with symptomatic desmoid fibromatosis requiring narcotic pain control may not benefit from this observational approach.
Why it matters
Potential benefit: If successful, this study could enhance understanding of desmoid-type fibromatosis and improve management strategies for patients.
How similar studies have performed: While observational studies in similar conditions have shown promise, this specific approach to desmoid-type fibromatosis is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
New York, New York
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Aimee M Crago, MD, PhD — Memorial Sloan Kettering Cancer Center
- Study coordinator: Aimee M Crago, MD, PhD
- Email: cragoa@mskcc.org
- Phone: 212-639-4807
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.