RECRUITING

Observing People With Desmoid-Type Fibromatosis

Conditions

Desmoid Fibromatosis Desmoid-Type Fibromatosis Desmoid Fibromatosis 20-026 Memorial Sloan Kettering Cancer Center

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

A Prospective Analysis of Active Observation in Patients With Desmoid-Type Fibromatosis

Quick Facts

Study Start:2020-02-19

Study Completion:2025-02-19

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04281381

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Aimee M Crago, MD, PhD

CONTACT

212-639-4807

cragoa@mskcc.org

Meera Hameed, MBBS

CONTACT

212-639-7959

hameedm@mskcc.org

Principal Investigator

Aimee M Crago, MD, PhD

PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

United States

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

Aimee M Crago, MD, PhD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-02-19

Study Completion Date2025-02-19

Study Record Updates

Study Start Date2020-02-19

Study Completion Date2025-02-19

Terms related to this study

Keywords Provided by Researchers

Desmoid-Type Fibromatosis
Desmoid Fibromatosis
Desmoid
Fibromatosis
20-026
Memorial Sloan Kettering Cancer Center

Additional Relevant MeSH Terms

Desmoid Fibromatosis