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Observing People With Desmoid-Type Fibromatosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04281381
Recruitment Status : Recruiting
First Posted : February 24, 2020
Last Update Posted : February 24, 2020
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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

Condition or disease Intervention/treatment
Desmoid Fibromatosis Diagnostic Test: Cross-sectional imaging

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Analysis of Active Observation in Patients With Desmoid-Type Fibromatosis
Actual Study Start Date : February 19, 2020
Estimated Primary Completion Date : February 19, 2024
Estimated Study Completion Date : February 19, 2024

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Desmoid Fibromatosis
Participants will have a clinical diagnosis of desmoid fibromatosis, either new or newly recurrent
Diagnostic Test: Cross-sectional imaging
MRI 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.




Primary Outcome Measures :
  1. Progression free survival [ Time Frame: 12 months ]
    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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
In most cases, patients will be identified by primary care providers in sarcoma medical and surgical oncology clinics.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04281381


Contacts
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Contact: Aimee M Crago, MD, PhD 212-639-4807 cragoa@mskcc.org
Contact: Meera Hameed, MBBS 212-639-7959 hameedm@mskcc.org

Locations
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United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Aimee M Crago, MD, PhD    212-639-4807      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Aimee M Crago, MD, PhD Memorial Sloan Kettering Cancer Center
Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT04281381    
Other Study ID Numbers: 20-026
First Posted: February 24, 2020    Key Record Dates
Last Update Posted: February 24, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Memorial Sloan Kettering Cancer Center:
Desmoid-Type Fibromatosis
Desmoid Fibromatosis
Desmoid
Fibromatosis
20-026
Memorial Sloan Kettering Cancer Center
Additional relevant MeSH terms:
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Fibromatosis, Aggressive
Fibroma
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms