Observing People With Desmoid-Type Fibromatosis

  • STATUS
    Recruiting
  • participants needed
    100
  • sponsor
    Memorial Sloan Kettering Cancer Center
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Updated on 19 February 2024
See if I qualify
fibromatosis
biospecimen collection
ct with intravenous contrast
aggressive fibromatosis

Summary

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

Details
Condition Aggressive fibromatosis
Age 18-100 years
Treatment Cross-sectional imaging
Clinical Study IdentifierNCT04281381
SponsorMemorial Sloan Kettering Cancer Center
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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