Localized 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
- Rochester, Minnesota: 22-006849
NCT ID: NCT04925089
Sponsor Protocol Number: HUM00213723
About this study
The purpose of this study is 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 ].
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 localized leiomyosarcoma (LMS) of extremity, body wall or
retroperitoneum.
- Grade 2 or 3, or high-grade LMS.
- Tumor size >5 cm in greatest dimension.
- Primary tumor amenable to complete resection.
- There is no age requirement.
- Participant agrees to receive neoadjuvant doxorubicin and ifosfamide combination
chemotherapy.
- If pre-operative radiation is administered, it must be administered after
chemotherapy. Post-operative radiation may be administered.
- Archival tumor tissue (either frozen sample, tissue block containing tumor, or minimum
of 4 unstained slides and 1 H&E stained slide) from diagnostic or pre-treatment biopsy
available for study research.
Exclusion Criteria:
- Any exception to Inclusion Criteria.
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 12/5/23. 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
|
More information
Publications
Publications are currently not available