An observational study in Leiomyosarcoma, sponsored by University of Utah. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-13.
Sponsored by University of Utah · Observational
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.
This is a descriptive study to explore attitudes to genomics and return of genetic information and examine the cognitive and affective impact of receiving germline genetic information among LMS patients and their family members.The present study will aim to do the following:
Prior studies of cancer patients have found a strong interest in genetic testing so at-risk relatives will have the opportunity to have increased cancer screening or take risk-reducing measures to prevent cancer. However, the genes most strongly associated with LMS are tumor protein 53 (TP53) gene and Retinoblastoma 1 (Rb1) gene. These genes cause risks for cancers that families may be less familiar with and that have less well-established approaches for screening and prevention.
LMS may not be the most significant cancer risk related to the syndrome associated with the PV identified. The finding of risk for other non-LMS cancers may be unexpected and incongruent with the family's experience or focus on the LMS being treated. Screening recommendations for relatives testing positive for these PV will generally be given cancer screening recommendations targeted towards risks for cancers other than LMS.
Patients beginning or in the midst of cancer treatment may be less able to share and effectively communicate about genetic test results to patients. We need to better understand how patients and family members respond to findings to maximize the clinical benefit of this information and support family communication.
LMS patients will be identified by querying the enterprise data warehouse (EDW) and Huntsman Tumor Registry and prospectively by reviewing clinic and tumor board lists.
177 studies on the registry are indexed under Leiomyosarcoma; 35 are open to participants now.
This study's planned enrollment of 300 is above the median of 250 across 15 observational studies indexed under Leiomyosarcoma.
Browse Leiomyosarcoma studies →University of Utah is the lead sponsor of 994 studies on the registry; 175 are open to participants now.
Of its 114 completed or terminated interventional studies of FDA-regulated products, 69 (61%) have results posted.
Counted across the registry records on this site, refreshed daily.
The study population will be Patients with a confirmed or suspected diagnosis of LMS and Relatives of LMS patients.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Relative of LMS Proband
Exclusion (both cohorts)
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.
Relatives to LMS probands will be enrolled in this cohort. Approximately 4 family members per proband will be recruited.
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.
Time frame: up to 1 day from study enrollment
Interest in germline genetic testing
This outcome will report the count of participants who self-reported an interest in germline genetic testing. This will report the number of participants who respond on a baseline questionnaire that they are interested in having a genetic test related to cancer risk.
Time frame: up to 1 day from study enrollment
Uptake in germline genetic testing
This outcome will report the count of participants who proceed with germline genetic testing. Participants will be asked on their baseline questionnaire if they have completed germline genetic testing.
Time frame: up to 1 day from study enrollment
Preferences for receiving information about germline testing
This outcome will report the count of participants who self-reported sources for genetic testing information as helpful. Participants will rank questions about sources of information from "1 Not helpful at all" to "6 Extremely helpful" on their baseline questionnaire. Participants who reported \>5 on this scale are considered to have found the source for genetic testing information as helpful. This outcome will assess information presented in tables and graphs and information presented numerically.
Time frame: up to 1 day from study enrollment
Plan to share: Yes — Deidentified IDP will be shared with the University of Michigan Rogel Cancer Center for data analysis.
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