Metastatic Leiomyosarcoma Biomarker Protocol

Overview

About this study

The primary objectives of this study are to examine the correlation of change in ctDNA with objective tumor response per Response Evaluation Criteria in Solid Tumors (RECIST), and to examine the correlation of change in ctDNA with progression free survival (PFS).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

- Patients with unresectable or metastatic leiomyosarcoma (LMS). There is no age
requirement.

- Receiving first-line chemotherapy with doxorubicin or gemcitabine/docetaxel.

- Sum of target lesions per RECIST1.1 of 5 cm or greater.

- Archival tumor tissue including 1 H&E stained slide and unstained tumor tissue (either
tissue block containing tumor, or minimum of 4 unstained slides - fresh frozen sample
may also be used in lieu of FFPE sample) available for study research.

Exclusion Criteria:

Any exception to the above Inclusion Criteria.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 4/25/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status	Contact
Rochester, Minn. Mayo Clinic principal investigator Brittany Siontis, M.D.	Open for enrollment	Contact information: Cancer Center Clinical Trials Referral Office (855) 776-0015

Mayo Clinic Location

Status

Contact

Rochester, Minn.

Mayo Clinic principal investigator

Brittany Siontis, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Clinical Trials