Beliefs, Attitudes, and Response to Genetic Testing in SarcomaPatients

NCT06875700 | Recruiting

• 2 other identifiers: HCI1655231P50CA272170-01
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Genomic research has shown that a portion of leiomyosarcomas can be attributed to an underlying cancer predisposition syndrome. However, the optimal approach for incorporating germline testing into the care of these patients. This study is assessing the beliefs about the heritability of leiomyosarcoma and other cancer risks, and attitudes towards germline testing among leiomyosarcoma patients.

Conditions

Leiomyosarcoma

Outcome Measures

Primary Outcomes (1)

• Beliefs about the heritability of Leiomyosarcoma

  This outcome will report the count of participants who self-reported a strong belief in heritability. Participants who responded on a questionnaire that sarcoma is somewhat or highly heritable are considered to have a strong belief in heritability. This outcome measure will be assessed on Day 1 of the study.

  up to 1 day from study enrollment

Secondary Outcomes (1)

• Interest in germline genetic testing

  up to 1 day from study enrollment

Other Outcomes (2)

• Uptake in germline genetic testing

  up to 1 day from study enrollment

• Preferences for receiving information about germline testing

  up to 1 day from study enrollment

Study Arms (2)

LMS Probands

LMS Probands are the first person in a family to be known to have a germline predisposition gene mutation in LMS. A cohort of patients with a histologically confirmed leiomyosarcoma diagnosis will be prospectively recruited from two SPORE prospective biomarker studies.

Relative of LMS Probands

Relatives to LMS probands will be enrolled in this cohort. Approximately 4 family members per proband will be recruited.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population will be Patients with a confirmed or suspected diagnosis of LMS and Relatives of LMS patients.

Inclusion LMS Proband * Actionable germline PV detected in the research context * Living * No prior germline testing for this PV * Able to speak and read English * Mentally competent * Age 18 or older Relative of LMS Proband * 25-50% chance for having inherited the PV * No prior germline testing for this PV * Able to speak and read English * Mentally competent * Age 18 or older Exclusion (both cohorts) * \<18 years * Unable to read or write

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Utah: lead
• National Cancer Institute (NCI): collaborator
• University of New South Wales: collaborator
• University of Michigan: collaborator

Study Sites (1)

Huntsman Cancer Institute at the University of Utah

Salt Lake City, Utah, 84112, United States

RECRUITING

MeSH Terms

Conditions

Leiomyosarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Central Study Contacts

Gregg Wood

CONTACT

8016464215; gregg.wood@hci.utah.edu

Study Design

• Study Type: observational
• Observational Model: FAMILY BASED
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2025
• First Posted: March 13, 2025
• Study Start: July 9, 2024
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: June 13, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share

Locations

US (1)