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Spots Global Cancer Trial Database for Localized Leiomyosarcoma Biomarker Protocol

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Trial Identification

Brief Title: Localized Leiomyosarcoma Biomarker Protocol

Official Title: Pilot Study of ctDNA and Imaging Characteristics as Biomarkers of Disease-related Outcomes in Patients With Localized Leiomyosarcoma Receiving Chemotherapy

Study ID: NCT04925089

Conditions

Leiomyosarcoma

Study Description

Brief Summary: * Leiomyosarcoma (LMS) is one of the more common soft tissue sarcomas (STS). * Patients presenting with large, high-grade, localized LMS are at significant risk of developing metastasis following curative surgery. * Clinical trials of neoadjuvant or adjuvant anthracycline and ifosfamide have suggested that patients with localized STS who are at high-risk of metastasis may benefit from chemotherapy, but the magnitude of benefit in unselected patient population is relatively small. * Currently, patient age, and tumor size and grade are used to assess risk of metastases and survival * Studies evaluating tumor response by imaging and histopathology have not established correlation between tumor characteristics as biomarkers for risk of metastasis or sarcoma recurrence. * Circulating tumor DNA (ctDNA) is present in blood of patients with advanced/metastatic LMS and may serve as biomarker of tumor response to chemotherapy. Blood samples will be collected prior to, during and after 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. Patients will be followed for 2 years after study entry for signs of sarcoma recurrence. * 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.

Detailed Description:

Eligibility

Minimum Age:

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

University of Michigan, Ann Arbor, Michigan, United States

Mayo Clinic, Rochester, Minnesota, United States

Memorial Sloan Kettering Cancer Center, New York, New York, United States

Vanderbilt University Medical Center, Nashville, Tennessee, United States

Contact Details

Name: Scott Schuetze

Affiliation: University of Michigan Rogal Cancer Center

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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