Recruiting

Germline Testing

Sponsor:

University of Utah

Code:

NCT06875700

Conditions

Leiomyosarcoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Study Details

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

Study ID

NCT06875700

Start date

Jul 9, 2024

Status verified date

Jun, 2025

Completion date

Aug, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • Beliefs about the heritability of Leiomyosarcoma [ Time Frame: up to 1 day from study enrollment ]

Central Contacts and Locations

Central contacts

Gregg Wood

8016464215gregg.wood@hci.utah.edu

Locations

Huntsman Cancer Institute at the University of Utah

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

Wendy K Kohlmann, MS

801-587-5556wendy.kohlmann@hci.utah.edu

Principal Investigator:

Wendy K Kohlmann, MS

More Information

Sponsor

University of Utah

Last update posted

Jun 13, 2025

Last verified

Jun, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Utah on 2025-06-13.