LCI-SAR-BSTS-CTDNA-001: Circulating Tumor DNA Liquid Biopsy in Sarcoma Patients

Официальное название

Prospective Clinical Evaluation of Circulating Tumor DNA Liquid Biopsy in Sarcoma Patients

Обзор

The purpose of this research study is to see how well Low Pass Whole Genome Sequencing (LP-WGS) can detect circulating tumor deoxyribonucleic acid (ctDNA) in the blood of participants who have bone or soft tissue sarcoma (type of cancer).

Подробное описание

In this ever-expanding age of precision oncology, the stagnant treatment algorithms and subsequent oncologic outcomes for sarcoma patients highlight the need for novel technologies to help clinicians treat these patients. While countless prognostic and therapeutic molecular biomarkers have been identified for many other cancers, sarcoma practitioners have strikingly few tumor markers to guide treatment. The development of a sarcoma-specific liquid biopsy could greatly help clinicians with diagnosis, prognostication, treatment response, minimal recurrent disease, and recurrence. The purpose of this study is to clinically evaluate ctDNA liquid biopsy approaches in adult and pediatric patients with bone and soft tissue sarcomas.

Вмешательства

• Другое Non-Metastatic and Resectable
  Blood Draw Timepoints: * Before any treatment begins * After Neo-adjuvant therapy (only if you receive this type of therapy) * After local surgery * After Adjuvant therapy (only if you receive this type of therapy) * Follow up after adjuvant therapy: at Months 3, 6, 9, 12, 15, 18, and 24 * After evidence of recurrence or worsening of disease, and then collected at standard of care disease evaluation visits up until 24 months from the last treatment for the initial diagnosis
• Другое Metastatic and Un-resectable
  Blood Draw Timepoints: * Before any treatment begins * During standard of care disease evaluation visits for up to 24 months
• Другое No evidence of disease, under surveillance
  Blood Draw Timepoints: * From completion of treatment- at Months 3, 6, 9, 12, 15, 18, and 24; depending on when you enroll into the study you will start at the next timepoint in this schedule * After evidence of recurrence or worsening of disease, and then collected at standard of care disease evaluation visits up until 24 months from the last treatment for the initial diagnosis
• Другое ALT or WDLS
  Blood Draw Timepoints: • Collect once after surgery (up to six weeks after surgery)

Первичные конечные точки

• Number of participants with ctDNA detected [Срок оценки: Approximately 24 months]

Вторичные конечные точки (1)

• Quantity of ctDNA detected [Срок оценки: Approximately 24 months]

Критерии участия

Критерии включения

• Written informed consent or assent when applicable from the participant, LAR, parent or legal guardian and HIPAA authorization for release of personal health information.
• All ages allowed
• Suspected or confirmed disease (must meet one of the criteria below):

• Suspected bone or soft tissue tumor concerning for sarcoma (pending confirmation of sarcoma diagnosis)

OR

• Suspected lipomatous mass concerning for ALT or WDLS with planned surgery

OR

• Confirmed bone or soft tissue sarcoma meeting one of the criteria below:

• Non-metastatic/Resectable sarcoma with either planned or currently receiving therapy
• Metastatic or unresectable sarcoma, with planned or currently receiving therapy
• Non-metastatic sarcoma under surveillance with no more than 1 year from completion of therapy

Критерии исключения

• none

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 · 2 центра

• Levine Cancer Institute — Charlotte
• Atrium Health Wake Forest Baptist Comprehensive Cancer Center — Winston-Salem

Идентификаторы

NCT: NCT06958107 · IRB00127078 · LCI-SAR-BSTS-CTDNA-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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