Localized Leiomyosarcoma Biomarker Protocol
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04925089|
Recruitment Status : Recruiting
First Posted : June 14, 2021
Last Update Posted : June 14, 2021
- 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.
- 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.
|Condition or disease||Intervention/treatment|
|Leiomyosarcoma||Other: Blood and Tissue collection|
|Study Type :||Observational|
|Estimated Enrollment :||40 participants|
|Official Title:||Pilot Study of ctDNA and Imaging Characteristics as Biomarkers of Disease-related Outcomes in Patients With Localized Leiomyosarcoma Receiving Chemotherapy|
|Estimated Study Start Date :||June 2021|
|Estimated Primary Completion Date :||June 2023|
|Estimated Study Completion Date :||June 2023|
- Other: Blood and Tissue collection
Blood and tissue will be collected and analyzed for detection of ctDNA
- To evaluate the association between tumor characteristics assessed by contrast-enhanced MRI and location with presence of circulating tumor DNA (ctDNA) in patients with localized, high-grade leiomyosarcoma [ Time Frame: 2 years ]Tumor characteristics from imaging will be compared to the presence of circulating tumor DNA , obtained from blood sampels over multiple time points
- To evaluate change in ctDNA in patients with localized, high-grade leiomyosarcoma undergoing preoperative doxorubicin/ifosfamide chemotherapy with or without pre-operative radiation [ Time Frame: 2 years ]Blood will be collected at multiple timepoints. The presence of ctDNA will be assessed prior to and after treatment with chemotherapy and / or radiation
- To examine the association of change in ctDNA and imaging characteristics with 2-year relapse-free survival [ Time Frame: 2 years ]The change in the presence of ctDNA from serial blood collection will be compared to the imaging characterstics in patients with relapse-free survival after 2 years
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04925089
|United States, Michigan|
|University of Michigan||Recruiting|
|Ann Arbor, Michigan, United States, 48109|
|Contact: Scott Schuetze, MD/PhD 734-647-8925|
|United States, Minnesota|
|Mayo Clinic||Not yet recruiting|
|Rochester, Minnesota, United States, 55901|
|Contact: Brittany Siontis, MD|
|United States, New York|
|Memorial Sloan Kettering Cancer Center||Not yet recruiting|
|New York, New York, United States, 10065|
|Contact: Sujana Movva, MD|
|United States, Tennessee|
|Vanderbilt University Medical Center||Not yet recruiting|
|Nashville, Tennessee, United States, 37232|
|Contact: Elizabeth J Davis, MD 615-322-5000|