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Metastatic Leiomyosarcoma Biomarker Protocol

NCT ID: NCT05653388

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-22

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Leiomyosarcoma

Keywords

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ctDNA Biomarker radiomics

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Plasma Collection

Intervention Type OTHER

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

Interventions

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Plasma Collection

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients with unresectable or metastatic leiomyosarcoma (LMS). There is no age requirement
* Receiving first-line chemotherapy with doxorubicin 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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of Michigan Rogel Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Scott Schuetze

Role: PRINCIPAL_INVESTIGATOR

University of Michigan Rogel Cancer Center

Locations

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Sarcoma Oncology Research Center

Santa Monica, California, United States

Site Status RECRUITING

University of Miami

Miami, Florida, United States

Site Status RECRUITING

Dana- Farber

Boston, Massachusetts, United States

Site Status RECRUITING

University of Michigan Cancer Center

Ann Arbor, Michigan, United States

Site Status RECRUITING

Mayo Clinic

Rochester, Minnesota, United States

Site Status RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status RECRUITING

Ohio State University

Columbus, Ohio, United States

Site Status RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status RECRUITING

MD Anderson

Houston, Texas, United States

Site Status RECRUITING

Chris O'Brien Lifehouse

Camperdown, New South Wales, Australia

Site Status RECRUITING

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

Site Status RECRUITING

Countries

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United States Australia

Central Contacts

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Scott Schuetze

Role: CONTACT

Phone: 734-647-8921

Email: [email protected]

Facility Contacts

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Allyssa Lingad

Role: primary

Gina D'Amato, MD

Role: primary

David Shulman, MD

Role: primary

Scott Schuetze, M.D., PhD.

Role: primary

Brittany Siontis, MD

Role: primary

Sujana Movva, MD

Role: primary

Gabriel Tinoco, MD

Role: primary

Elizabeth J Davis, MD

Role: primary

Elise Nassif Haddad, MD, PhD

Role: primary

Peter Grimison

Role: primary

Stephen Luen

Role: primary

Other Identifiers

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1P50CA272170-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HUM00219342

Identifier Type: OTHER

Identifier Source: secondary_id

HUM00216516

Identifier Type: OTHER

Identifier Source: secondary_id

HUM00216516

Identifier Type: -

Identifier Source: org_study_id