Pediatric Solid Tumor, Unspecified, Protocol SpecificNCT05068583
Liquid Biopsies in Pediatric Solid Tumors
An observational study of Pediatric Solid Tumor, Unspecified, Protocol Specific, run by Children's Hospital Los Angeles at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months and olderHealthy volunteers can take part
- Conditions the study is for
- Pediatric Solid Tumor, Unspecified, Protocol Specific
- What is being tested?
- Blood Draw
- How many people
- 320 participants
- Where
- 1 siteUnited States
- Study dates
- 8 May 2019to 8 May 2034
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- CNS Malignancies
- Individuals < 6 months of age
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Children's Hospital Los Angeles
Los Angeles, California, 90027
Anya Zdanowicz, 323-361-5418
About this study
Official title: 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.
Read the 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).
- Being tested
- Blood Draw
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood DrawOther
Blood draw at baseline, disease evaluation time point, and pre and post surgery and/or radiation.
| Study group | Role | What they receive |
|---|---|---|
| Osteosarcoma | Not described Receives: Other: Blood Draw | |
| Ewing Sarcoma | Not described Receives: Other: Blood Draw | |
| Rhabdomyosarcoma | Not described Receives: Other: Blood Draw | |
| Synovial Sarcoma | Not described Receives: Other: Blood Draw | |
| Non-Rhabdomyosarcoma Soft Tissue Sarcoma | Not described Receives: Other: Blood Draw | |
| Hepatic Tumors | Not described Receives: Other: Blood Draw | |
| Renal Tumors | Not described Receives: Other: Blood Draw | |
| Thyroid Tumors | Not described Receives: Other: Blood Draw | |
| Germ Cell Tumors | Not described Receives: Other: Blood Draw | |
| Healthy Volunteers | Not described Receives: Other: Blood Draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2021
- Study start8 May 2019
- Primary completion8 May 2029 (estimated)
- Study completion8 May 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Solid Tumor, Unspecified, Protocol SpecificStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fariba Navid, Children's Hospital Los Angeles
- Investigators
- Fariba Navid, MD, Principal investigator, Children's Hospital Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05068583
- Sponsor's protocol ID
- CHLA-19-00146
- Status last verified
- Aug 2024
- First submitted
- 30 Aug 2021
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: For patients that are alive, we do not plan to share IPD.
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liquid Biopsies in Non-CNS Malignant Pediatric Solid Tumors
- ClinicalTrials.gov ID
- NCT05068583
- Acronym / sponsor ID
- CHLA-19-00146
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Children's Hospital Los AngelesUniversity, hospital or other
- Study start
- 8 May 2019 (actual)
- Primary completion
- 8 May 2029 (estimated)
- Study completion
- 8 May 2034 (estimated)
- First posted
- 6 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- CNS Malignancies
- Individuals < 6 months of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood DrawBlood draw at baseline, disease evaluation time point, and pre and post surgery and/or radiation. | Other | Ewing Sarcoma, Germ Cell Tumors, Healthy Volunteers, Hepatic Tumors, Non-Rhabdomyosarcoma Soft Tissue Sarcoma, Osteosarcoma, Renal Tumors, Rhabdomyosarcoma, Synovial Sarcoma, Thyroid Tumors |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- Individual participant dataSharing planned: No. For patients that are alive, we do not plan to share IPD.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fariba Navid, MD principal investigator
Children's Hospital Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Solid Tumor, Unspecified, Protocol Specific, run by Children's Hospital Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fariba Navid, MD (323-361-2529, fnavid@chla.usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2024.