This study evaluates the use of liquid biopsies in detecting ctDNA and ctRNA in newly diagnosed, relapsed, or refractory high grade bone or soft tissue sarcoma or malignant renal, thyroid, germ cell, or hepatic tumors.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05068583.
Locations matching your search criteria
United States
California
Los Angeles
Children's Hospital Los AngelesStatus: Active
Contact: Fariba Navid
PRIMARY OBJECTIVES:
I. To determine the feasibility of detecting circulating tumor DNA (ctDNA), circulating tumor cells (CTCs), and circulating tumor RNA (ctRNA) in serial blood samples from patients with newly diagnosed and relapsed/refractory malignant pediatric solid tumors.
II. To evaluate the kinetics of ctDNA and CTCs in patients with newly diagnosed and relapsed/refractory pediatric solid tumors during therapy (including the perioperative period) and after completion of therapy and correlate these findings with response by conventional methods (e.g., imaging studies, histologic tumor response, and serum tumor markers) and outcome.
III. To compare the ctDNA profile with the genetic profile of the primary, metastatic or recurrent tumor, if available.
IV. To compare different assays for the detection of ctDNA in patients with osteosarcoma, Ewing sarcoma, synovial sarcoma, and rhabdomyosarcoma.
V. To explore whether RNA or DNA isolated from tumor-derived exosomes from cancer patients differs from that of healthy controls and correlates with tumor response, relapse, and outcome.
VI. To explore differences in DNA isolated from tumor-derived exosomes from plasma and ctDNA in patients with osteosarcoma.
VII. To bank leftover plasma samples for future studies.
OUTLINE: This is an observational study. Participants are assigned to 1 of 2 groups.
GROUP I (CANCER PATIENTS): Patients undergo blood sample collection and have their medical records reviewed throughout the study.
GROUP II (HEALTHY CONTROL SUBJECTS): Healthy participants undergo a one time blood sample collection on study.
Trial PhaseNo phase specified
Trial Typediagnostic
Lead OrganizationChildren's Hospital Los Angeles
Principal InvestigatorFariba Navid