Liquid Biopsies in Pediatric Solid Tumors

Recruiting

• Conditions: Pediatric Solid Tumor, Unspecified, Protocol Specific
• Interventions: Other: Blood Draw

• Registration Number: NCT05068583
• Lead Sponsor: Children's Hospital Los Angeles

Brief Summary

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

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).

Study Timeline

• Study Start: 2019-05-08
• Study First Submitted: 2021-08-30
• Study First Submitted QC: 2021-09-24
• Study First Posted: 2021-10-06
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-19
• Last Update Posted: 2024-08-21
• Primary Completion: 2029-05-08
• Study Completion: 2034-05-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 320

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

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Exclusion Criteria

• CNS Malignancies
• Individuals < 6 months of age

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-Rhabdomyosarcoma Soft Tissue Sarcoma	Blood Draw	-
Ewing Sarcoma	Blood Draw	-
Hepatic Tumors	Blood Draw	-
Healthy Volunteers	Blood Draw	-
Osteosarcoma	Blood Draw	-
Rhabdomyosarcoma	Blood Draw	-
Synovial Sarcoma	Blood Draw	-
Renal Tumors	Blood Draw	-
Thyroid Tumors	Blood Draw	-
Germ Cell Tumors	Blood Draw	-

Primary Outcome Measures

Name	Time	Method
To detect circulating tumor DNA (ctDNA) in serial blood samples from patients with pediatric non-CNS solid tumors using low pass whole genome sequencing.	10 years	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.

Trial Locations

Locations (1)

Children's Hospital Los Angeles; 🇺🇸 Los Angeles, California, United States