Germ Cell TumorNCT05564026
Molecular Epidemiology of Pediatric Germ Cell Tumors
An observational study of Germ Cell Tumor and Germinoma, run by Children's Oncology Group at 1 site in United States.
Trial summary
A Non-Therapeutic Study that aims to establish a cohort of GCT survivors to understand short term and long-term adverse effects of treatment and to conduct molecular analyses to improve risk stratification. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Germ Cell Tumor, Germinoma, Teratoma
- What is being tested?
- Questionnaire Administration, Tumor Specimen Collection and Germline DNA Samples
- Type of treatment
- Surgery or procedure
- How many people
- 1,151 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Apr 2023to 30 Jun 2027
- 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
- Child, Adult, Older adult
Study population: Pediatric and adolescent Germ Cell Tumor survivors recruited from recently completed Children's Oncology Group (COG) epidemiology study (AEPI10N1) and the COG Project:EveryChild Registry (APEC14B1).
Who may be able to join
- Cases will be eligible for the study if they have a primary diagnosis of GCT including germinoma (ICCC code105 9060-9065), teratoma (9080-9084), embryonal carcinoma (9070-9072), yolk sac tumor (9071), choriocarcinoma (9100, 9103, 9104), and mixed GCT (9085, 9101, 9102, 9105) in all sites including the brain.
- The patient must be enrolled on APEC14B1 with consent to future contact or enrolled in AEPI10N1 with consent for future contact (N=827). Patients enrolled in AEPI10N1 were recruited from ACCRN07. All patients must be registered with COG by a North American member institution. Note: (history of) treatment on a COG therapeutic trial is not required.
- Patients must be diagnosed at < 20 years of age at the time of GCT diagnosis. Study participants will be followed over time in the survivorship study so there is no maximum age for participation.
- Participants must be able to complete study related documents in English or Spanish.
- All patients and/or their parents or legal guardians must provide informed consent. Assent will be obtained for participants between the ages of 8-17 years.
- All institutional, FDA, and NCI requirements for human studies must be met.
Who cannot join
- Participants from AEPI10N1 who did not consent to future contact. Patients who do not meet the eligibility criteria described above or cannot complete study materials in English or Spanish
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
University of Minnesota
Minneapolis, Minnesota, 55455
Jenny Poynter, PhD, 612-625-4232, poynt006@umn.edu
About this study
Official title: Pediatric Germ Cell Tumors: Outcomes, Genomics and Epigenetics
A Non-Therapeutic Study that aims to establish a cohort of GCT survivors to understand short term and long-term adverse effects of treatment and to conduct molecular analyses to improve risk stratification.
Read the detailed description
PRIMARY OBJECTIVES:
- Establish a survivorship cohort for pediatric and adolescent GCT comprised of participants from AEPI10N1 and APEC14B1 to assess short term and long-term adverse events associated with GCT treatment.
II. Compare somatic variation by tumor histology to identify molecular signatures that improve prognostic risk stratification.
III. Identify methylation patterns that predict poor clinical outcomes, including disease relapse and death.
OUTLINE:
Medical records from pediatric and adolescent Germ Cell Tumor (GCT) participants from AEPI10N1 and APEC14B1 will be used to obtain treatment information and validate self-reported outcomes. Paired normal and tumor samples will be used to evaluate single nucleotide variants, indels, copy number variations, and DNA methylation patterns. Ototoxicity will be determined by central review of audiogram files obtained from the treating institutions and self-reported based on questionnaire data.
- Conditions
- Germ Cell Tumor, Germinoma, Teratoma, Embryonal Carcinoma, Yolk Sac Tumor, Choriocarcinoma
- Being tested
- Questionnaire Administration, Tumor Specimen Collection, Germline DNA Samples, Blood Sample Collection
- Medical subject headings
- Neoplasms, Germ Cell and Embryonal, Germinoma, Teratoma, Carcinoma, Embryonal, Endodermal Sinus Tumor, Choriocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire AdministrationOther
Questionnaire provide to participant's about their health and quality of life since treatment
Tumor Specimen CollectionOther
Tumor DNA requested from the Biopathology Center
Germline DNA SamplesOther
Germline DNA specimens requested from the Biopathology Center or newly collected saliva
Blood Sample CollectionProcedure or surgery
Collection and storing of serum/plasma
| Study group | Role | What they receive |
|---|---|---|
| Ancillary-Correlative | Children and adolescents with a germ cell tumor, previously enrolled on APEC14B1 or AEPI10N1 who allow access to medical records (including audiograms), grant permission to: evaluate of all of their DNA, place their genetic and health information in scientific databanks, and collect a blood sample at a routine clinic/home visit, as well as complete a questionnaire about your health and quality of life since treatment. Receives: Other: Questionnaire Administration; Other: Tumor Specimen Collection; Other: Germline DNA Samples; Procedure: Blood Sample Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ototoxicity
Ototoxicity as determined by central review of end of therapy audiograms will serve as the primary outcome variable for analyses. Current ototoxicity will be assessed using an app-based hearing assessment. For the app-based audiometry assessment, unilateral hearing loss will be defined as at least one pure tone threshold greater than 25 decibels across at any one of the frequencies from 2,000 Hz- 8,000 Hz to align with the SIOP Boston guidelines, while bilateral hearing loss will be defined as a pure tone threshold > 25 decibels in both ears at any one of the frequencies.
Measured: Up to 5 years
Somatic Mutations
Compare somatic variation by tumor histology to identify molecular signatures that improve prognostic risk stratification. Somatic mutations will be identified by comparing tumor samples to normal samples. Risk stratification will be based on event free survival, defined as the time from diagnosis to relapse or death.
Measured: Up to 5 years
Methylation
Compare the association between DNA methylation patterns and relapse or death. Mixed-effects regression models will be used to test for association between methylation beta values and poor outcomes. The outcome will be defined as a binary variable with a value of one if the patient experienced a relapse or death event and zero otherwise.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2022
- Study start12 Apr 2023
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Germ Cell TumorStudies of the same condition, open and under way.
- More trials run by Children's Oncology GroupThe sponsor's other registered studies.
- 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
- Family based
- Time perspective
- Prospective
- Enrolment
- 1,151 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Oncology Group
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Jenny Poynter, PhD, Principal investigator, Children's Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05564026
- Sponsor's protocol ID
- AEPI17N3
- Status last verified
- Sep 2025
- First submitted
- 29 Sep 2022
- Last updated
- 24 Oct 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Germ Cell Tumors: Outcomes, Genomics and Epigenetics
- ClinicalTrials.gov ID
- NCT05564026
- Acronym / sponsor ID
- AEPI17N3
- Conditions
- Germ Cell Tumor, Germinoma, Teratoma, Embryonal Carcinoma, Yolk Sac Tumor, Choriocarcinoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,151 participants (estimated)
- Lead sponsor
- Children's Oncology GroupResearch network
- Study start
- 12 Apr 2023 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 3 Oct 2022 (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.
A Non-Therapeutic Study that aims to establish a cohort of GCT survivors to understand short term and long-term adverse effects of treatment and to conduct molecular analyses to improve risk stratification.
Detailed description
PRIMARY OBJECTIVES:
- Establish a survivorship cohort for pediatric and adolescent GCT comprised of participants from AEPI10N1 and APEC14B1 to assess short term and long-term adverse events associated with GCT treatment.
II. Compare somatic variation by tumor histology to identify molecular signatures that improve prognostic risk stratification.
III. Identify methylation patterns that predict poor clinical outcomes, including disease relapse and death.
OUTLINE:
Medical records from pediatric and adolescent Germ Cell Tumor (GCT) participants from AEPI10N1 and APEC14B1 will be used to obtain treatment information and validate self-reported outcomes. Paired normal and tumor samples will be used to evaluate single nucleotide variants, indels, copy number variations, and DNA methylation patterns. Ototoxicity will be determined by central review of audiogram files obtained from the treating institutions and self-reported based on questionnaire data.
Study design
- Observational model
- Family based
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ancillary-Correlative | – | Other: Questionnaire Administration, Other: Tumor Specimen Collection, Other: Germline DNA Samples, Procedure: Blood Sample CollectionChildren and adolescents with a germ cell tumor, previously enrolled on APEC14B1 or AEPI10N1 who allow access to medical records (including audiograms), grant permission to: evaluate of all of their DNA, place their genetic and health information in scientific databanks, and collect a blood sample at a routine clinic/home visit, as well as complete a questionnaire about your health and quality of life since treatment. |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Pediatric and adolescent Germ Cell Tumor survivors recruited from recently completed Children's Oncology Group (COG) epidemiology study (AEPI10N1) and the COG Project:EveryChild Registry (APEC14B1).
Key inclusion criteria (6 listed)
- Cases will be eligible for the study if they have a primary diagnosis of GCT including germinoma (ICCC code105 9060-9065), teratoma (9080-9084), embryonal carcinoma (9070-9072), yolk sac tumor (9071), choriocarcinoma (9100, 9103, 9104), and mixed GCT (9085, 9101, 9102, 9105) in all sites including the brain.
- The patient must be enrolled on APEC14B1 with consent to future contact or enrolled in AEPI10N1 with consent for future contact (N=827). Patients enrolled in AEPI10N1 were recruited from ACCRN07. All patients must be registered with COG by a North American member institution. Note: (history of) treatment on a COG therapeutic trial is not required.
- Patients must be diagnosed at < 20 years of age at the time of GCT diagnosis. Study participants will be followed over time in the survivorship study so there is no maximum age for participation.
- Participants must be able to complete study related documents in English or Spanish.
- All patients and/or their parents or legal guardians must provide informed consent. Assent will be obtained for participants between the ages of 8-17 years.
Key exclusion criteria (1 listed)
- Participants from AEPI10N1 who did not consent to future contact. Patients who do not meet the eligibility criteria described above or cannot complete study materials in English or Spanish
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 |
|---|---|---|
| Questionnaire AdministrationQuestionnaire provide to participant's about their health and quality of life since treatment | Other | Ancillary-Correlative |
| Tumor Specimen CollectionTumor DNA requested from the Biopathology Center | Other | Ancillary-Correlative |
| Germline DNA SamplesGermline DNA specimens requested from the Biopathology Center or newly collected saliva | Other | Ancillary-Correlative |
| Blood Sample CollectionCollection and storing of serum/plasma | Procedure or surgery | Ancillary-Correlative |
Primary outcome
Ototoxicity
Time frame: Up to 5 years
Ototoxicity as determined by central review of end of therapy audiograms will serve as the primary outcome variable for analyses. Current ototoxicity will be assessed using an app-based hearing assessment. For the app-based audiometry assessment, unilateral hearing loss will be defined as at least one pure tone threshold greater than 25 decibels across at any one of the frequencies from 2,000 Hz- 8,000 Hz to align with the SIOP Boston guidelines, while bilateral hearing loss will be defined as a pure tone threshold > 25 decibels in both ears at any one of the frequencies.
Somatic Mutations
Time frame: Up to 5 years
Compare somatic variation by tumor histology to identify molecular signatures that improve prognostic risk stratification. Somatic mutations will be identified by comparing tumor samples to normal samples. Risk stratification will be based on event free survival, defined as the time from diagnosis to relapse or death.
Methylation
Time frame: Up to 5 years
Compare the association between DNA methylation patterns and relapse or death. Mixed-effects regression models will be used to test for association between methylation beta values and poor outcomes. The outcome will be defined as a binary variable with a value of one if the patient experienced a relapse or death event and zero otherwise.
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 24 Oct 2025.
Related trials for Germ Cell Tumor
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 1
IL-17 Blockade to Decrease irAEs (REPLAY)
Metastatic Melanoma
RecruitingPhase 2
A UGT1A1 Genotype-Directed Study of Belinostat Pharmacokinetics and Toxicity
Carcinoma, Neuroendocrine, Tumor, Neuroendocrine
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
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.
Jenny Poynter, PhD principal investigator
Children's Oncology Group
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 Germ Cell Tumor and Germinoma, run by Children's Oncology Group 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 6 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 24 Oct 2025. 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 Jenny Poynter ((612) 625-4232, poynt006@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ototoxicity (time frame: Up to 5 years). The study lists 3 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 24 Oct 2025.