Not provided
Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1P50CA272170-01 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| University of New South Wales | UNKNOWN |
| University of Michigan | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 1 day from study enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 1 day from study enrollment |
| Preferences for receiving information about germline testing |
Inclusion LMS Proband
Relative of LMS Proband
Exclusion (both cohorts)
Not provided
Not provided
Not provided
The study population will be Patients with a confirmed or suspected diagnosis of LMS and Relatives of LMS patients.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gregg Wood | Contact | 8016464215 | gregg.wood@hci.utah.edu |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huntsman Cancer Institute at the University of Utah | Recruiting | Salt Lake City | Utah | 84112 | United States |
Deidentified IDP will be shared with the University of Michigan Rogel Cancer Center for data analysis.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007890 | Leiomyosarcoma |
| ID | Term |
|---|---|
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
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. |
| up to 1 day from study enrollment |
| D012509 | Sarcoma |