LeiomyosarcomaNCT05653388
Metastatic Leiomyosarcoma Biomarker Protocol
An observational study of Leiomyosarcoma, run by University of Michigan Rogel Cancer Center at 11 sites in 2 countries.
Trial summary
Leiomyosarcoma (LMS) is one of the most prevalent soft tissue sarcomas (STS) and can occur in various sites including soft tissue, uterus and retroperitoneal large vessels. Metastatic disease occurs in approximately 50% of patients diagnosed with leiomyosarcoma and prognosis is poor in setting of metastatic disease. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Leiomyosarcoma
- What is being tested?
- Plasma Collection
- How many people
- 200 participants
- Where
- 11 sitesin 2 countries
- Study dates
- 22 Dec 2022to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with unresectable or metastatic leiomyosarcoma
Who may be able to join
- Patients with unresectable or metastatic leiomyosarcoma (LMS). There is no age requirement
- Receiving first-line chemotherapy with doxorubicin- based or gemcitabine/docetaxel
- Target lesions per RECIST 1.1
- Optional archival tumor tissue including 1 H\&E-stained slide and unstained tumor tissue [either tissue block containing tumor, or minimum of 4 unstained slides (preferably 8 unstained slides)-fresh frozen sample may also be used in lieu of FFPE sample] available for study research
Who cannot join
None listed.
Trial locations and contacts
11 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
11 sites in 2 countries
United States9 sites, 9 recruiting
- Recruiting
University of Michigan Cancer Center
Ann Arbor, Michigan, 48109
Scott Schuetze, M.D., PhD., 734-647-8925
Scott Schuetze, M.D., PhD
- Recruiting
Dana- Farber
Boston, Massachusetts, 02215
David Shulman, MD
- Recruiting
Ohio State University
Columbus, Ohio, 43210
Gabriel Tinoco, MD
- Recruiting
MD Anderson
Houston, Texas, 77030
Elise Nassif Haddad, MD, PhD, 281-460-0607, efnassif@mdanderson.org
- Recruiting
University of Miami
Miami, Florida, 33136
Gina D'Amato, MD
Gina D'Amato, MD
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Elizabeth J Davis, MD, 615-322-5000
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Sujana Movva, MD
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55901
Brittany Siontis, MD
- Recruiting
Sarcoma Oncology Research Center
Santa Monica, California, 90403
Allyssa Lingad, 310-552-9999, alingad@sarcomaoncology.com
Sant P Chawla, MD
Australia2 sites, 2 recruiting
- Recruiting
Chris O'Brien Lifehouse
Camperdown, New South Wales, 2050
Peter Grimison, Peter.grimison@lh.org.au
- Recruiting
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000
Stephen Luen, stephen.luen@petermac.org
About this study
Official title: Observational Study of Biomarkers of Disease-related Outcomes in Patients With Metastatic Leiomyosarcoma Receiving Chemotherapy
Leiomyosarcoma (LMS) is one of the most prevalent soft tissue sarcomas (STS) and can occur in various sites including soft tissue, uterus and retroperitoneal large vessels. Metastatic disease occurs in approximately 50% of patients diagnosed with leiomyosarcoma and prognosis is poor in setting of metastatic disease. A minority of patients benefit from treatment with chemotherapy and early biomarkers of benefit from treatment are lacking. 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. Circulating tumor DNA (ctDNA) is present in blood of patients with advanced/metastatic cancer and may serve as biomarker of tumor response to chemotherapy. Blood samples will be collected prior to and during and 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. Study participants will be asked to complete a questionnaire on attitudes and understanding of genetics and genetic testing.
- Conditions
- Leiomyosarcoma
- Being tested
- Plasma Collection
- Keywords
- ctDNA, Biomarker, radiomics
- Medical subject headings
- Leiomyosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasma CollectionOther
Patients will provide tissue and blood samples. No medical intervention will be completed for study purposes
| Study group | Role | What they receive |
|---|---|---|
| Enrolled Subjects | Once enrolled subjects will provide Optional Archival Tissue, Optional Fresh tumor for a biopsy and blood collections at baseline, optional day 8 of cycle 1, day 1 of cycles 2-6 and at progression Receives: Other: Plasma Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ctDNA with RECIST
To examine the correlation of change in ctDNA with objective tumor response per RECIST. Analysis will occur at each subsequent early time-point (pre-cycle 1 and pre-cycle 2).
Measured: 4 years from study start
Change in ctDNA with progression free survival (PFS)
To examine the correlation of change in ctDNA with progression free survival (PFS). Analysis of ctDNA will occur at each subsequent early time-point (pre-cycle 1 and pre-cycle 2). A Cox regression model will determine whether the baseline ctDNA levels are associated with PFS.
Measured: 54 months from study start
Secondary outcomes (1)
Frequency of ctDNA in patients with unresectable or metastatic leiomyosarcoma.
Plasma collections for ctDNA analysis will be collected at each subsequent early time-point (pre-cycle 1 and pre-cycle 2).
Measured: 4 years from study start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2022
- Study start22 Dec 2022
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeiomyosarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Scott Schuetze, Principal investigator, University of Michigan Rogel Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05653388
- Sponsor's protocol ID
- HUM00216516
- Other IDs
- 1P50CA272170-01, HUM00219342, HUM00216516
- Status last verified
- Jun 2026
- First submitted
- 7 Dec 2022
- Last updated
- 24 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share deidentified genetic data on the NIH site, and deidentified imaging data will be shared with the lab at Columbia University. We are not sharing patient identities.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Biomarkers of Disease-related Outcomes in Patients With Metastatic Leiomyosarcoma Receiving Chemotherapy
- ClinicalTrials.gov ID
- NCT05653388
- Acronym / sponsor ID
- HUM00216516
- Conditions
- Leiomyosarcoma
- Keywords
- ctDNA, Biomarker, radiomics
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 22 Dec 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 16 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Leiomyosarcoma (LMS) is one of the most prevalent soft tissue sarcomas (STS) and can occur in various sites including soft tissue, uterus and retroperitoneal large vessels. Metastatic disease occurs in approximately 50% of patients diagnosed with leiomyosarcoma and prognosis is poor in setting of metastatic disease. A minority of patients benefit from treatment with chemotherapy and early biomarkers of benefit from treatment are lacking. 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. Circulating tumor DNA (ctDNA) is present in blood of patients with advanced/metastatic cancer and may serve as biomarker of tumor response to chemotherapy. Blood samples will be collected prior to and during and 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. Study participants will be asked to complete a questionnaire on attitudes and understanding of genetics and genetic testing.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Enrolled Subjects | – | Other: Plasma CollectionOnce enrolled subjects will provide Optional Archival Tissue, Optional Fresh tumor for a biopsy and blood collections at baseline, optional day 8 of cycle 1, day 1 of cycles 2-6 and at progression |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with unresectable or metastatic leiomyosarcoma
Key inclusion criteria (4 listed)
- Patients with unresectable or metastatic leiomyosarcoma (LMS). There is no age requirement
- Receiving first-line chemotherapy with doxorubicin- based or gemcitabine/docetaxel
- Target lesions per RECIST 1.1
- Optional archival tumor tissue including 1 H\&E-stained slide and unstained tumor tissue [either tissue block containing tumor, or minimum of 4 unstained slides (preferably 8 unstained slides)-fresh frozen sample may also be used in lieu of FFPE sample] available for study research
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plasma CollectionPatients will provide tissue and blood samples. No medical intervention will be completed for study purposes | Other | Enrolled Subjects |
Primary outcome
Change in ctDNA with RECIST
Time frame: 4 years from study start
To examine the correlation of change in ctDNA with objective tumor response per RECIST. Analysis will occur at each subsequent early time-point (pre-cycle 1 and pre-cycle 2).
Change in ctDNA with progression free survival (PFS)
Time frame: 54 months from study start
To examine the correlation of change in ctDNA with progression free survival (PFS). Analysis of ctDNA will occur at each subsequent early time-point (pre-cycle 1 and pre-cycle 2). A Cox regression model will determine whether the baseline ctDNA levels are associated with PFS.
1 secondary outcome
Frequency of ctDNA in patients with unresectable or metastatic leiomyosarcoma.
Time frame: 4 years from study start
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Individual participant dataSharing planned: Yes. We will share deidentified genetic data on the NIH site, and deidentified imaging data will be shared with the lab at Columbia University. We are not sharing patient identities.
Related trials for Leiomyosarcoma
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Scott Schuetze principal investigator
University of Michigan Rogel Cancer Center
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leiomyosarcoma, run by University of Michigan Rogel Cancer Center at 11 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Scott Schuetze (734-647-8921, scotschu@med.umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ctDNA with RECIST (time frame: 4 years from study start). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.