Metastatic Leiomyosarcoma Biomarker Protocol
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Jacksonville, Florida: 23-004743
- Rochester, Minnesota: 23-004743
NCT ID: NCT05653388
Sponsor Protocol Number: HUM00216516
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 |
Jacksonville, Fla.
Mayo Clinic principal investigator |
Contact us for the latest status |
Contact information:
Cancer Center Clinical Trials Referral Office
(855) 776-0015
|
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