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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

Tracking Information
First Submitted Date June 8, 2021
First Posted Date June 14, 2021
Last Update Posted Date June 14, 2021
Estimated Study Start Date June 2021
Estimated Primary Completion Date June 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 11, 2021)
  • 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
  • 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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: June 11, 2021)
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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Localized Leiomyosarcoma Biomarker Protocol
Official Title Pilot Study of ctDNA and Imaging Characteristics as Biomarkers of Disease-related Outcomes in Patients With Localized Leiomyosarcoma Receiving Chemotherapy
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
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.
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
Condition Leiomyosarcoma
Intervention Other: Blood and Tissue collection
Blood and tissue will be collected and analyzed for detection of ctDNA
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 11, 2021)
40
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2023
Estimated Primary Completion Date June 2023   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: SARC 734-930-7600 sarc@sarctrials.org
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04925089
Other Study ID Numbers SARC043
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Sarcoma Alliance for Research through Collaboration
Study Sponsor Sarcoma Alliance for Research through Collaboration
Collaborators Not Provided
Investigators Not Provided
PRS Account Sarcoma Alliance for Research through Collaboration
Verification Date June 2021