Liquid Biopsies in Pediatric Solid Tumors

NCT05068583 | Recruiting

• 1 other identifier: CHLA-19-00146
• Study Type: observational
• Target: 320
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Solid Tumor, Unspecified, Protocol Specific

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (10)

Osteosarcoma

Other: Blood Draw

Ewing Sarcoma

Other: Blood Draw

Rhabdomyosarcoma

Other: Blood Draw

Synovial Sarcoma

Other: Blood Draw

Non-Rhabdomyosarcoma Soft Tissue Sarcoma

Other: Blood Draw

Hepatic Tumors

Other: Blood Draw

Renal Tumors

Other: Blood Draw

Thyroid Tumors

Other: Blood Draw

Germ Cell Tumors

Other: Blood Draw

Healthy Volunteers

Other: Blood Draw

Interventions

Blood Draw OTHER

Blood draw at baseline, disease evaluation time point, and pre and post surgery and/or radiation.

Ewing Sarcoma; Germ Cell Tumors; Healthy Volunteers; Hepatic Tumors; Non-Rhabdomyosarcoma Soft Tissue Sarcoma; Osteosarcoma; Renal Tumors; Rhabdomyosarcoma; Synovial Sarcoma; Thyroid Tumors

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• CNS Malignancies
• Individuals \< 6 months of age

Sponsors & Collaborators

• Children's Hospital Los Angeles: lead

Study Sites (1)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Fariba Navid, MD

  Children's Hospital Los Angeles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fariba Navid, MD

CONTACT

323-361-2529; fnavid@chla.usc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: August 30, 2021
• First Posted: October 6, 2021
• Study Start: May 8, 2019
• Primary Completion (Estimated): May 8, 2029
• Study Completion (Estimated): May 8, 2034
• Last Updated: August 21, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)