Liquid Biopsies in Pediatric Solid Tumors

Liquid Biopsies in Non-CNS Malignant Pediatric Solid Tumors

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.

Study Overview

• Status: Recruiting
• Conditions: Pediatric Solid Tumor, Unspecified, Protocol Specific
• Intervention / Treatment: Other: Blood Draw

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 Type: Observational
• Enrollment (Estimated): 320

Contacts and Locations

• Study Contact: Name: Fariba Navid, MD; Phone Number: 323-361-2529; Email: fnavid@chla.usc.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90027
      • Recruiting
      • Children's Hospital Los Angeles
      • Contact: Anya Zdanowicz; Phone Number: 323-361-5418

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

10

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Children's Hospital Los Angeles
• Investigators: Principal Investigator: Fariba Navid, MD, Children's Hospital Los Angeles

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2019
• Primary Completion (Estimated): May 8, 2029
• Study Completion (Estimated): May 8, 2034

Study Registration Dates

• First Submitted: August 30, 2021
• First Submitted That Met QC Criteria: September 24, 2021
• First Posted (Actual): October 6, 2021

Study Record Updates

• Last Update Posted (Actual): August 21, 2024
• Last Update Submitted That Met QC Criteria: August 19, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: CHLA-19-00146

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: For patients that are alive, we do not plan to share IPD.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No