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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05653388




Registration number
NCT05653388
Ethics application status
Date submitted
7/12/2022
Date registered
16/12/2022
Date last updated
26/06/2024

Titles & IDs
Public title
Metastatic Leiomyosarcoma Biomarker Protocol
Scientific title
Observational Study of Biomarkers of Disease-related Outcomes in Patients With Metastatic Leiomyosarcoma Receiving Chemotherapy
Secondary ID [1] 0 0
1P50CA272170-01
Secondary ID [2] 0 0
HUM00216516
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Leiomyosarcoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Sarcoma (also see 'Bone') - soft tissue

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - Plasma Collection

Enrolled Subjects - Once enrolled subjects will provide Archival Tissue, Optional Fresh tumor from a biopsy and blood collections at baseline, day 8 of cycle 1, day 1 of cycles 2-6, and at progression.


Other interventions: Plasma Collection
Patients will provide tissue and blood samples. No medical intervention will be completed for study purposes
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in ctDNA with RECIST
Timepoint [1] 0 0
4 years from study start
Primary outcome [2] 0 0
Change in ctDNA with progression free survival (PFS)
Timepoint [2] 0 0
54 months from study start
Secondary outcome [1] 0 0
Frequency of ctDNA in patients with unresectable or metastatic leiomyosarcoma.
Timepoint [1] 0 0
4 years from study start

Eligibility
Key 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
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/12/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2026
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,UNSWVIC
Recruitment hospital [1] 0 0
Chris O'Brien Lifehouse - Camperdown
Recruitment hospital [2] 0 0
Centre for Molecular Oncology - Sydney
Recruitment hospital [3] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2052 - Sydney
Recruitment postcode(s) [3] 0 0
3000 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Massachusetts
Country [2] 0 0
United States of America
State/province [2] 0 0
Michigan
Country [3] 0 0
United States of America
State/province [3] 0 0
Minnesota
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
Ohio
Country [6] 0 0
United States of America
State/province [6] 0 0
Tennessee
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas

Funding & Sponsors
Primary sponsor type
Other
Name
University of Michigan Rogel Cancer Center
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Cancer Institute (NCI)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief 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. 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.
Trial website
https://clinicaltrials.gov/study/NCT05653388
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Scott Schuetze
Address 0 0
University of Michigan Rogel Cancer Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Scott Schuetze
Address 0 0
Country 0 0
Phone 0 0
734-647-8921
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05653388