An observational study in Pediatric Solid Tumor, Unspecified, Protocol Specific, sponsored by Children's Hospital Los Angeles. Recruiting at 1 site in United States. Open to participants aged 6 Months and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-21.
Sponsored by Children's Hospital Los Angeles · Observational
This study is being done to determine if traces of tumor can be found in the blood before, during, and after patients stop treatment. We will analyze the tumor material to see if it is similar to tumor tissue and if the tumor material in blood is helpful in monitoring the disease.
Liquid biopsies, particularly those involving cell-free DNA (cfDNA), are a promising non-invasive, cost effective method of monitoring disease in cancer patients with solid tumors and are being increasingly employed in various adult malignancies to diagnose disease, monitor tumor response, detect relapse and learn more about tumor biology. The utility of liquid biopsies which may include isolation and analysis of tumor derived material such as DNA, RNA, intact cells, proteins, or exosomes from blood or other bodily fluids in pediatric solid tumors has not been established. In this study, we propose to prospectively collect serial blood samples at baseline, during therapy, end of therapy, relapse, and during follow up from patients ≥ 6 months of age with newly diagnosed or relapsed/refractory various pediatric non-CNS malignant solid tumors to determine the feasibility of detecting various tumor-derived material, including exosomes, circulating tumor cells, and circulating tumor nucleic acid (ctDNA and ctRNA). The timing of blood sample collection will be during a routine lab draw around the time of a disease evaluation. The ctDNA and ctRNA as well as DNA and RNA extracted from tumor-derived exosomes will be quantified at each time point and the findings will be correlated with conventional methods for disease evaluation (e.g., imaging studies, histologic tumor response, or serum tumor markers) and outcome (overall survival and event-free survival).
Children's Hospital Los Angeles is the lead sponsor of 152 studies on the registry; 47 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients over the age of 6 months who are newly diagnosed, relapsed, or refractory histologically confirmed high grade bone or soft tissue sarcoma or malignant renal, thyroid, germ cell, or hepatic tumors. Also, healthy individuals with no history of cancer or chronic medical problems who are \< 21 years of age.
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Exclusion Criteria:
Other: Blood Draw
Other: Blood Draw
Other: Blood Draw
Other: Blood Draw
Other: Blood Draw
Other: Blood Draw
Other: Blood Draw
Other: Blood Draw
Other: Blood Draw
Other: Blood Draw
Blood draw at baseline, disease evaluation time point, and pre and post surgery and/or radiation.
To detect circulating tumor DNA (ctDNA) in serial blood samples from patients with pediatric non-CNS solid tumors using low pass whole genome sequencing.
To determine how often circulating tumor DNA (ctDNA), circulating tumor cells (CTCs), and circulating tumor RNA (ctRNA) is detected in serial blood samples from patients with newly diagnosed and relapsed/refractory malignant pediatric solid tumors.
Time frame: 10 years
Plan to share: No — For patients that are alive, we do not plan to share IPD.
No publications or documents are linked to this record.
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