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NCT Number: NCT05068583

Liquid Biopsies in 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.

Recruiting

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Key information

Age range

6 month and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location status: Recruiting

Location contact

Anya Zdanowicz

CONTACT

323-361-5418

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood Draw

Other

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

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.

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Fariba Navid, MD

CONTACT

[email protected]

323-361-2529

Sponsors and collaborators

Lead sponsor

Children's Hospital Los Angeles

Other

Registry information

Official study title

Liquid Biopsies in Non-CNS Malignant Pediatric Solid Tumors

Important dates

Study start
2019
Primary completion
2029
Study completion
2034
First posted
Oct 6, 2021
Registry last updated
Aug 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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