RECRUITING

Metastatic Leiomyosarcoma Biomarker Protocol

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Observational Study of Biomarkers of Disease-related Outcomes in Patients With Metastatic Leiomyosarcoma Receiving Chemotherapy

Quick Facts

Study Start:2022-12-22
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05653388

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients with unresectable or metastatic leiomyosarcoma (LMS). There is no age requirement
  2. * Receiving first-line chemotherapy with doxorubicin or gemcitabine/docetaxel
  3. * Target lesions per RECIST 1.1
  4. * 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
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Scott Schuetze
CONTACT
734-647-8921
scotschu@med.umich.edu

Principal Investigator

Scott Schuetze
PRINCIPAL_INVESTIGATOR
University of Michigan Rogel Cancer Center

Study Locations (Sites)

Dana- Farber
Boston, Massachusetts, 02215
United States
University of Michigan Cancer Center
Ann Arbor, Michigan, 48109
United States
Mayo Clinic
Rochester, Minnesota, 55901
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
Ohio State University
Columbus, Ohio, 43210
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
United States
MD Anderson
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: University of Michigan Rogel Cancer Center

  • Scott Schuetze, PRINCIPAL_INVESTIGATOR, University of Michigan Rogel Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-12-22
Study Completion Date2026-12

Study Record Updates

Study Start Date2022-12-22
Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

  • ctDNA
  • Biomarker
  • radiomics

Additional Relevant MeSH Terms

  • Leiomyosarcoma