Liquid Biopsies in Pediatric Solid Tumors

Children's Hospital Los Angeles

Status: Enrolling

Conditions: Pediatric Solid Tumor, Unspecified, Protocol Specific

Treatments: Other: Blood Draw

Study type: Observational

Funder types: Other

Identifiers

NCT05068583

CHLA-19-00146

Details and patient eligibility

About

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.

Full 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).

Enrollment: 320 estimated patients

Sex: All

Ages: 6+ months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

320 participants in 10 patient groups

Osteosarcoma

Treatment:

Other: Blood Draw

Ewing Sarcoma

Treatment:

Other: Blood Draw

Rhabdomyosarcoma

Treatment:

Other: Blood Draw

Synovial Sarcoma

Treatment:

Other: Blood Draw

Non-Rhabdomyosarcoma Soft Tissue Sarcoma

Treatment:

Other: Blood Draw

Hepatic Tumors

Treatment:

Other: Blood Draw

Renal Tumors

Treatment:

Other: Blood Draw

Thyroid Tumors

Treatment:

Other: Blood Draw

Germ Cell Tumors

Treatment:

Other: Blood Draw

Healthy Volunteers

Treatment:

Other: Blood Draw