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Localized Leiomyosarcoma Biomarker Protocol

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ClinicalTrials.gov Identifier: NCT04925089
Recruitment Status : Recruiting
First Posted : June 14, 2021
Last Update Posted : June 14, 2021
Sponsor:
Information provided by (Responsible Party):
Sarcoma Alliance for Research through Collaboration

Brief Summary:
  • Leiomyosarcoma (LMS) is one of the more common soft tissue sarcomas (STS).
  • Patients presenting with large, high-grade, localized LMS are at significant risk of developing metastasis following curative surgery.
  • Clinical trials of neoadjuvant or adjuvant anthracycline and ifosfamide have suggested that patients with localized STS who are at high-risk of metastasis may benefit from chemotherapy, but the magnitude of benefit in unselected patient population is relatively small.
  • Currently, patient age, and tumor size and grade are used to assess risk of metastases and survival
  • Studies evaluating tumor response by imaging and histopathology have not established correlation between tumor characteristics as biomarkers for risk of metastasis or sarcoma recurrence.
  • Circulating tumor DNA (ctDNA) is present in blood of patients with advanced/metastatic LMS and may serve as biomarker of tumor response to chemotherapy.
  • 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.

Condition or disease Intervention/treatment
Leiomyosarcoma Other: Blood and Tissue collection

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pilot Study of ctDNA and Imaging Characteristics as Biomarkers of Disease-related Outcomes in Patients With Localized Leiomyosarcoma Receiving Chemotherapy
Estimated Study Start Date : June 2021
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: Blood and Tissue collection
    Blood and tissue will be collected and analyzed for detection of ctDNA


Primary Outcome Measures :
  1. 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 ]
    Tumor characteristics from imaging will be compared to the presence of circulating tumor DNA , obtained from blood sampels over multiple time points

  2. To evaluate change in ctDNA in patients with localized, high-grade leiomyosarcoma undergoing preoperative doxorubicin/ifosfamide chemotherapy with or without pre-operative radiation [ Time Frame: 2 years ]
    Blood will be collected at multiple timepoints. The presence of ctDNA will be assessed prior to and after treatment with chemotherapy and / or radiation


Secondary Outcome Measures :
  1. To examine the association of change in ctDNA and imaging characteristics with 2-year relapse-free survival [ Time Frame: 2 years ]
    The change in the presence of ctDNA from serial blood collection will be compared to the imaging characterstics in patients with relapse-free survival after 2 years


Biospecimen Retention:   Samples With DNA
Blood will be obtained after enrollment for analysis of germ-line DNA and analyzed for ctDNA. Archival tissue will be collected. Tumor tissue from sarcoma resection will be collected. Digital Images will be collected.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who have been diagnosed with grade 2 or 3, high-grade leiomyosarcoma who have agreed to receive neoadjuvant doxorubicin and ifosfamide combination chemotherapy where the primary tumor is amenable to complete resection
Criteria

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; however, high-grade LMS is exceeding rare in children
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04925089


Contacts
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Contact: SARC 734-930-7600 sarc@sarctrials.org

Locations
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United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Scott Schuetze, MD/PhD    734-647-8925      
United States, Minnesota
Mayo Clinic Not yet recruiting
Rochester, Minnesota, United States, 55901
Contact: Brittany Siontis, MD         
United States, New York
Memorial Sloan Kettering Cancer Center Not yet recruiting
New York, New York, United States, 10065
Contact: Sujana Movva, MD         
United States, Tennessee
Vanderbilt University Medical Center Not yet recruiting
Nashville, Tennessee, United States, 37232
Contact: Elizabeth J Davis, MD    615-322-5000      
Sponsors and Collaborators
Sarcoma Alliance for Research through Collaboration
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Responsible Party: Sarcoma Alliance for Research through Collaboration
ClinicalTrials.gov Identifier: NCT04925089    
Other Study ID Numbers: SARC043
First Posted: June 14, 2021    Key Record Dates
Last Update Posted: June 14, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leiomyosarcoma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Sarcoma