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Registry to Collect Health Information About Desmoplastic Small Round Cell Tumor

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: NCT04690374
Recruitment Status : Recruiting
First Posted : December 30, 2020
Last Update Posted : January 10, 2022
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Description
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Brief Summary:

This study is a patient registry of people with Desmoplastic Small Round Cell Tumor (DSRCT). A patient registry is a collection of health information about a group of people, and it is usually focused on a specific diagnosis or disease.

The purpose of this registry is to create a database- a collection of information-or better understanding DSRCT. Researchers will use the information from this database to learn more about DSRCT and for current and future research on DSRCT.


Condition or disease
Desmoplastic Small Round Cell Tumor

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 10 Years
Official Title: Registry for Patients With Desmoplastic Small Round Cell Tumor
Actual Study Start Date : December 22, 2020
Estimated Primary Completion Date : December 2027
Estimated Study Completion Date : December 2027

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Desmoplastic small round cell tumor (DSRCT)
Collect historical/longitudinal clinical, radiographic and molecular features of DSRCT patients as documented in medical records to improve knowledge about DSRCT


Outcome Measures
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Primary Outcome Measures :
  1. Registry to Collect Health Information About Desmoplastic Small Round Cell Tumor [ Time Frame: 7 years ]
    The aim of this study is the collection of data.


Eligibility Criteria
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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:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study is a registry protocol for patients with DSRCT.
Criteria

Inclusion Criteria:

  • Participants must have a diagnosis of desmoplastic small round cell tumor
  • Participants may be of any age as long as the appropriate consent and assent may be obtained
  • Willing to provide historical and longitudinal clinical data

Exclusion Criteria:

  • Participant unwilling to provide consent or share historical and longitudinal clinical data
Contacts and Locations
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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): NCT04690374


Contacts
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Contact: Emily Slotkin, MD 1-833-675-5437 slotkine@mskcc.org
Contact: Shakeel Modak, MD 1-833-675-5437

Locations
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United States, New York
Memorial Sloan Kettering Cancer Center (All Protocol Activities) Recruiting
New York, New York, United States, 10065
Contact: Emily Slotkin, MD    833-675-5437      
Contact: Shakeel Modak, MD    1-833-675-5437      
Principal Investigator: Emily Slotkin, MD         
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Emily Slotkin, MD Memorial Sloan Kettering Cancer Center
More Information
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Additional Information:

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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT04690374    
Other Study ID Numbers: 20-551
First Posted: December 30, 2020    Key Record Dates
Last Update Posted: January 10, 2022
Last Verified: January 2022
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:
Patient registry
20-551
Additional relevant MeSH terms:
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Desmoplastic Small Round Cell Tumor
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms