Metastatic Leiomyosarcoma Biomarker Protocol

University of Michigan Rogel Cancer Center

Status: Enrolling

Conditions: Leiomyosarcoma

Treatments: Other: Plasma Collection

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT05653388

1P50CA272170-01 (U.S. NIH Grant/Contract)

HUM00219342 (Other Identifier)

HUM00216516 (Other Identifier)

Details and patient eligibility

About

Leiomyosarcoma (LMS) is one of the most prevalent soft tissue sarcomas (STS) and can occur in various sites including soft tissue, uterus and retroperitoneal large vessels. Metastatic disease occurs in approximately 50% of patients diagnosed with leiomyosarcoma and prognosis is poor in setting of metastatic disease. A minority of patients benefit from treatment with chemotherapy and early biomarkers of benefit from treatment are lacking. A biomarker of tumor response and patient survival benefit from chemotherapy early in the course of chemotherapy would be of significant impact in treatment planning. Circulating tumor DNA (ctDNA) is present in blood of patients with advanced/metastatic cancer and may serve as biomarker of tumor response to chemotherapy. Blood samples will be collected prior to and during and chemotherapy, and analyzed for ctDNA and for mutations in genes that are associated with increased risk of developing sarcoma. Tumor tissue will be collected and analyzed for changes in genes. Digital images of the sarcoma from CT or MRI scans obtained during treatment will be obtained for advanced radiomic analysis. Study participants will be asked to complete a questionnaire on attitudes and understanding of genetics and genetic testing.

Enrollment: 200 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Patients with unresectable or metastatic leiomyosarcoma (LMS). There is no age requirement
• Receiving first-line chemotherapy with doxorubicin or gemcitabine/docetaxel
• Sum of target lesions per RECIST1.1 of 5 cm or greater
• Archival tumor tissue including 1 H&E stained slide and unstained tumor tissue (either tissue block containing tumor, or minimum of 4 unstained slides - fresh frozen sample may also be used in lieu of FFPE sample) available for study research

Trial design

200 participants in 1 patient group

Enrolled Subjects

Description:

Once enrolled subjects will provide Archival Tissue, Optional Fresh tumor from a biopsy and blood collections at baseline, day 8 of cycle 1, day 1 of cycles 2-6, and at progression.

Treatment:

Other: Plasma Collection