Liquid Biopsies in Pediatric Solid Tumors

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Liquid Biopsies in Non-CNS Malignant Pediatric Solid Tumors

Conditions
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Pediatric Solid Tumor, Unspecified, Protocol Specific

Intervention / Treatment
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* Other: Blood Draw


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Newly diagnosed, relapsed, or refractory histologically confirmed high grade bone or soft tissue sarcoma or malignant renal, thyroid, germ cell, or hepatic tumors, OR Healthy individual with no history of cancer or chronic medical problems and < 21 years of age Exclusion Criteria: CNS Malignancies Individuals < 6 months of age

Ages Eligible for Study
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Minimum Age: 6 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Osteosarcoma<br> | Other: Blood Draw<br>* Blood draw at baseline, disease evaluation time point, and pre and post surgery and/or radiation.<br>|
| Ewing Sarcoma<br> | Other: Blood Draw<br>* Blood draw at baseline, disease evaluation time point, and pre and post surgery and/or radiation.<br>|
| Rhabdomyosarcoma<br> | Other: Blood Draw<br>* Blood draw at baseline, disease evaluation time point, and pre and post surgery and/or radiation.<br>|
| Synovial Sarcoma<br> | Other: Blood Draw<br>* Blood draw at baseline, disease evaluation time point, and pre and post surgery and/or radiation.<br>|
| Non-Rhabdomyosarcoma Soft Tissue Sarcoma<br> | Other: Blood Draw<br>* Blood draw at baseline, disease evaluation time point, and pre and post surgery and/or radiation.<br>|
| Hepatic Tumors<br> | Other: Blood Draw<br>* Blood draw at baseline, disease evaluation time point, and pre and post surgery and/or radiation.<br>|
| Renal Tumors<br> | Other: Blood Draw<br>* Blood draw at baseline, disease evaluation time point, and pre and post surgery and/or radiation.<br>|
| Thyroid Tumors<br> | Other: Blood Draw<br>* Blood draw at baseline, disease evaluation time point, and pre and post surgery and/or radiation.<br>|
| Germ Cell Tumors<br> | Other: Blood Draw<br>* Blood draw at baseline, disease evaluation time point, and pre and post surgery and/or radiation.<br>|
| Healthy Volunteers<br> | Other: Blood Draw<br>* Blood draw at baseline, disease evaluation time point, and pre and post surgery and/or radiation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 10 years |