Recruiting

ctDNA

Sponsor:

University of Michigan Rogel Cancer Center

Code:

NCT05653388

Conditions

Leiomyosarcoma

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Plasma Collection

Study Details

Brief summary:

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.

Conditions

Leiomyosarcoma

Study ID

NCT05653388

Start date

Dec 22, 2022

Status verified date

Jun, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients with unresectable or metastatic leiomyosarcoma (LMS). There is no age requirement
  • Receiving first-line chemotherapy with doxorubicin- based or gemcitabine/docetaxel
  • Target lesions per RECIST 1.1
  • Optional archival tumor tissue including 1 H\&E-stained slide and unstained tumor tissue \[either tissue block containing tumor, or minimum of 4 unstained slides (preferably 8 unstained slides)-fresh frozen sample may also be used in lieu of FFPE sample\] available for study research

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

Enrolled Subjects

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

Interventions

Plasma Collection

Patients will provide tissue and blood samples. No medical intervention will be completed for study purposes

Primary outcome measure

  • Change in ctDNA with RECIST [ Time Frame: 4 years from study start ]
  • Change in ctDNA with progression free survival (PFS) [ Time Frame: 54 months from study start ]

Central Contacts and Locations

Central contacts

Locations

Sarcoma Oncology Research Center

Recruiting

Santa Monica, California, United States, 90403

Contacts

Principal Investigator:

Sant P Chawla, MD

University of Miami

Recruiting

Miami, Florida, United States, 33136

Principal Investigator:

Gina D'Amato, MD

Dana- Farber

Recruiting

Boston, Massachusetts, United States, 02215

University of Michigan Cancer Center

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Scott Schuetze, M.D., PhD.

734-647-8925

Principal Investigator:

Scott Schuetze, M.D., PhD

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55901

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Elizabeth J Davis, MD

615-322-5000

MD Anderson

Recruiting

Houston, Texas, United States, 77030

Contacts

Elise Nassif Haddad, MD, PhD

281-460-0607efnassif@mdanderson.org

More Information

Sponsor

University of Michigan Rogel Cancer Center

Last update posted

Jun 24, 2026

Last verified

Jun, 2026

Keywords

  • ctDNA
  • Biomarker
  • radiomics

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 Michigan Rogel Cancer Center on 2026-06-24.