Localized Leiomyosarcoma Biomarker Protocol

Официальное название

Pilot Study of ctDNA and Imaging Characteristics as Biomarkers of Disease-related Outcomes in Patients With Localized Leiomyosarcoma Receiving Chemotherapy

Обзор

* 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. Blood samples will be collected prior to, during and after 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. Patients will be followed for 2 years after study entry for signs of sarcoma recurrence. * 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.

Вмешательства

• Другое Blood and Tissue collection
  Blood and tissue will be collected and analyzed for detection of ctDNA and genetic change

Первичные конечные точки

• 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 [Срок оценки: 2 years]
• To evaluate change in ctDNA in patients with localized, high-grade leiomyosarcoma undergoing preoperative doxorubicin/ifosfamide chemotherapy with or without pre-operative radiation [Срок оценки: 2 years]

Вторичные конечные точки (1)

• To examine the association of change in ctDNA and imaging characteristics with 2-year relapse-free survival [Срок оценки: 2 years]

Критерии участия

Критерии включения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 3 центра

• University of Michigan — Ann Arbor
• Mayo Clinic — Rochester
• Vanderbilt University Medical Center — Nashville

Публикации

• Kasper B, Wilky BA. Sounding the Alarm on Leiomyosarcoma Recurrence: Role of Circulating Tumor DNA. Clin Cancer Res. 2022 Jun 13;28(12):2480-2481. doi: 10.1158/1078-0432.CCR-22-0738. PMID 35412607

Идентификаторы

NCT: NCT04925089 · HUM00219057 · HUM00213723 · 1P50CA272170-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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