Pediatric CancerNCT04715178
Beat Childhood Cancer Specimen Banking and Data Registry
An observational study of Pediatric Cancer and Survivorship, run by Giselle Sholler at 18 sites in United States.
Trial summary
This is an observational data registry study of pediatric cancer patients at participating Beat Childhood Cancer Consortium sites involving specimen banking and data collection. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pediatric Cancer, Survivorship
- How many people
- 1,000 participants
- Where
- 18 sitesUnited States
- Study dates
- 2 Feb 2021to Jan 2032
- How long will I take part?
- 10 Years
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Pediatric cancer subjects, survivorship, and healthy volunteers at The Pennsylvania State University and participating Beat Childhood Cancer Research Consortium sites.
Who may be able to join
- No age restrictions
- Subjects that fit into one of the following categories:
- Subjects with suspected or confirmed cancers of childhood, adolescence, or young adulthood.
- Survivors of a cancer of childhood, adolescence, or young adulthood (> 6 months off last therapy for cancer)
- Subjects with a disease-matched condition
- Healthy volunteers- including any participants with medical conditions that are not disease-matched.
- Written informed consent in accordance with institutional and FDA guidelines must be obtained from all subjects (or subjects' legal representative).
Who cannot join
- Subject or his/her legally authorized representative (where applicable) did not consent for specimen banking and data collection for this study.
Trial locations and contacts
18 sites in 1 country. Contact the study team or a site near you to ask about taking part.
18 sites in 1 country
United States18 sites, 17 recruiting
- Recruiting
Dell Children's Blood and Cancer Center
Austin, Texas, 78723
Rhea Robinson, RN, rmrobinson@ascension.org
Michael Mitchell
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Shanta Salzar, MD, salzers@musc.edu
Jaqueline Kraveka
- Completed
Levine Children's Hospital
Charlotte, North Carolina, 28204
- Recruiting
Connecticut Children's Hospital
Hartford, Connecticut, 06106
Adam Barselau, Abarselau@connecticutchildrens.org
Michael Isakoff
- Recruiting
Penn State Milton S. Hershey Medical Center and Children's Hospital
Hershey, Pennsylvania, 17033
Penn State Clinical Trials, ExtractClinicalTrials@pennstatehealth.psu.edu
Valerie Brown
- Recruiting
University of Iowa
Iowa City, Iowa, 52242
Christopher Stamy, chris-stamy@uiowa.edu
Sara Horton
- Recruiting
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, 64108
Nicole Harvey, ndharvey@cmh.edu
Kevin Ginn
- Recruiting
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
Susan Hall, HallSF@archildrens.org
Kevin Bielamowicz
- Recruiting
Norton Children's Research Institute/Affiliated with University of Louisville School of Medicine
Louisville, Kentucky, 40292
Jennifer Miller, Jennifer.Miller4@nortonhealthcare.org
Michael Ferguson
- Recruiting
Nicklaus Children's Miami
Miami, Florida, 33155
Aixa Guadarrama, Aixa.Guadarrama@Nicklaushealth.org
Maggie Fader
- Recruiting
Children's Hospital and Clinics of Minnesota
Minneapolis, Minnesota, 55404
Pauline Mitby, pauline.mitby@childrensmn.org
Jawhar Rawwas
- Recruiting
Children's Hospital of The King's Daughters
Norfolk, Virginia, 23507
Sabrina Wigginton, Sabrina.Wigginton@chkd.org
Wilson File
- Recruiting
Arnold Palmer Hospital for Children
Orlando, Florida, 32806
Marie Frankos, marie.frankos@orlandohealth.com
Jaime Libes-Bander
- Recruiting
Randall Children's Hospital
Portland, Oregon, 97227
Aaron White, AJWHITE@lhs.org
Jason Glover
- Recruiting
Rady Children's Hospital
San Diego, California, 92123
Sarah Hollander, shollander@rchsd.org
William Roberts
- Recruiting
Cardinal Glennon Children's Hospital
St Louis, Missouri, 63104
Gina Martin, gina.martin@health.slu.edu
William Ferguson
- Recruiting
St. Joseph's Children's Hospital
Tampa, Florida, 33614
Jennifer Manns, RN, jennifer.manns@baycare.org
Don Eslin
- Recruiting
AH Wake Forest Baptist - Brenner Children's Hospital
Winston-Salem, North Carolina, 27157
Graham Keyes, grkeyes@wakehealth.edu
Mariah Wright-Nadkarni
About this study
Official title: Specimen Banking With Clinical and Genomic Data Registry With the Establishment of Tumor Models for Pediatric Cancers
This is an observational data registry study of pediatric cancer patients at participating Beat Childhood Cancer Consortium sites involving specimen banking and data collection.
Read the detailed description
This observational registry and banking study is being performed on a large cohort of subjects who have received molecular testing to better understand the relationship between genomic and molecular information and clinical outcomes, and to enable timely and informed treatment decisions by physicians for their cancers. We hypothesize that large gene panels, sequencing (DNA/RNA), and epigenetics of tumors can identify molecular aberrations that can be leveraged to offer more effective treatment. Findings may highlight additional areas of research required to better understand the molecular underpinnings of the relationship between molecular abnormalities and disease. Banked specimens and the creation of tumor cell lines and xenograft models will facilitate further advancement of this research.
- Conditions
- Pediatric Cancer, Survivorship
- Being tested
- No intervention- registry only
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention- registry onlyOther
No intervention- registry only
| Study group | Role | What they receive |
|---|---|---|
| Patients with suspected or confirmed pediatric solid tumors | Patients with suspected or confirmed pediatric solid tumors Receives: Other: No intervention- registry only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Create a data registry of clinical and molecular/genomic data
Create a data registry of clinical and molecular/genomic data from cancer patients who have undergone biopsy or surgical resection for clinical care to better understand the relationship between genomic and molecular information and clinical outcomes.
Measured: 10 Years
Determine number and types of genomic alterations within tumor types/subtypes
Define genomic landscape of pediatric cancers through the determination of the number and types of genomic alterations within tumor types/subtypes, across tumor types, and tumor evolution over time.
Measured: 10 Years
Evaluate the rate of actionable genomic alternations
Evaluate the rate of actionable genomic alternations resulting in associated targeted therapies relative to all actionable genomic alterations.
Measured: 10 Years
Evaluate the correlation of baseline genomic alterations with clinical outcome.
Evaluate the correlation of baseline genomic alterations with clinical outcome.
Measured: 10 Years
Identify biomarkers that predict risk of adverse outcomes that occur following pediatric cancer therapy.
Identify biomarkers that predict risk of adverse outcomes that occur following pediatric cancer therapy.
Measured: 10 Years
Secondary outcomes (4)
Bank additional specimens available for future research projects
Bank additional specimens available for future research projects
Measured: 10 Years
Develop cell line and xenograft models of pediatric cancers for future research
Develop cell line and xenograft models of pediatric cancers for future research
Measured: 10 Years
Identify biomarkers that predict risks of disease states in subject controls that did not receive cancer therapy.
Identify biomarkers that predict risks of disease states in subject controls that did not receive cancer therapy.
Measured: 10 Years
Identify biomarkers that may predict risk of disease dependent on sex, race, ethnicity, or the presence of comorbidities.
Identify biomarkers that may predict risk of disease dependent on sex, race, ethnicity, or the presence of comorbidities.
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 posted20 Jan 2021
- Study start2 Feb 2021
- Primary completionJan 2031 (estimated)
- Study completionJan 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric CancerStudies 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
- 1,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Giselle Sholler
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Giselle Sholler, Milton S. Hershey Medical Center
- Investigators
- Giselle Sholler, MD, Study chair, Beat Childhood Cancer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04715178
- Sponsor's protocol ID
- BCC-BIO-001
- Status last verified
- Jan 2026
- First submitted
- 15 Jan 2021
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Specimen Banking With Clinical and Genomic Data Registry With the Establishment of Tumor Models for Pediatric Cancers
- ClinicalTrials.gov ID
- NCT04715178
- Acronym / sponsor ID
- BCC-BIO-001
- Conditions
- Pediatric Cancer, Survivorship
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Giselle ShollerUniversity, hospital or other
- Study start
- 2 Feb 2021 (actual)
- Primary completion
- Jan 2031 (estimated)
- Study completion
- Jan 2032 (estimated)
- First posted
- 20 Jan 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 is an observational data registry study of pediatric cancer patients at participating Beat Childhood Cancer Consortium sites involving specimen banking and data collection.
Detailed description
This observational registry and banking study is being performed on a large cohort of subjects who have received molecular testing to better understand the relationship between genomic and molecular information and clinical outcomes, and to enable timely and informed treatment decisions by physicians for their cancers. We hypothesize that large gene panels, sequencing (DNA/RNA), and epigenetics of tumors can identify molecular aberrations that can be leveraged to offer more effective treatment. Findings may highlight additional areas of research required to better understand the molecular underpinnings of the relationship between molecular abnormalities and disease. Banked specimens and the creation of tumor cell lines and xenograft models will facilitate further advancement of this research.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with suspected or confirmed pediatric solid tumors | – | Other: No intervention- registry onlyPatients with suspected or confirmed pediatric solid tumors |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pediatric cancer subjects, survivorship, and healthy volunteers at The Pennsylvania State University and participating Beat Childhood Cancer Research Consortium sites.
Key inclusion criteria (7 listed)
- No age restrictions
- Subjects that fit into one of the following categories:
- Written informed consent in accordance with institutional and FDA guidelines must be obtained from all subjects (or subjects' legal representative).
Key exclusion criteria (1 listed)
- Subject or his/her legally authorized representative (where applicable) did not consent for specimen banking and data collection for this study.
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 |
|---|---|---|
| No intervention- registry onlyNo intervention- registry only | Other | Patients with suspected or confirmed pediatric solid tumors |
Primary outcome
Create a data registry of clinical and molecular/genomic data
Time frame: 10 Years
Create a data registry of clinical and molecular/genomic data from cancer patients who have undergone biopsy or surgical resection for clinical care to better understand the relationship between genomic and molecular information and clinical outcomes.
Determine number and types of genomic alterations within tumor types/subtypes
Time frame: 10 Years
Define genomic landscape of pediatric cancers through the determination of the number and types of genomic alterations within tumor types/subtypes, across tumor types, and tumor evolution over time.
Evaluate the rate of actionable genomic alternations
Time frame: 10 Years
Evaluate the rate of actionable genomic alternations resulting in associated targeted therapies relative to all actionable genomic alterations.
Evaluate the correlation of baseline genomic alterations with clinical outcome.
Time frame: 10 Years
Evaluate the correlation of baseline genomic alterations with clinical outcome.
Identify biomarkers that predict risk of adverse outcomes that occur following pediatric cancer therapy.
Time frame: 10 Years
Identify biomarkers that predict risk of adverse outcomes that occur following pediatric cancer therapy.
4 secondary outcomes
Bank additional specimens available for future research projects
Time frame: 10 Years
Develop cell line and xenograft models of pediatric cancers for future research
Time frame: 10 Years
Identify biomarkers that predict risks of disease states in subject controls that did not receive cancer therapy.
Time frame: 10 Years
Identify biomarkers that may predict risk of disease dependent on sex, race, ethnicity, or the presence of comorbidities.
Time frame: 10 Years
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 3 Feb 2026.
- Beat Childhood Cancer Consortium websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Giselle Sholler, MD study chair
Beat Childhood Cancer
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Cancer and Survivorship, run by Giselle Sholler at 18 sites 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 7 inclusion and 1 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 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites 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 BCC Enroll (7175310003, BCCEnroll@pennstatehealth.psu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Create a data registry of clinical and molecular/genomic data (time frame: 10 Years). The study lists 5 primary outcomes in all. 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 3 Feb 2026.