- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05564026
Molecular Epidemiology of Pediatric Germ Cell Tumors
Pediatric Germ Cell Tumors: Outcomes, Genomics and Epigenetics
Study Overview
Status
Conditions
Detailed Description
PRIMARY OBJECTIVES:
I. 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 Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55455
- Recruiting
- University of Minnesota
-
Contact:
- Jenny Poynter, PhD
- Phone Number: 612-625-4232
- Email: poynt006@umn.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Family-Based
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
Questionnaire provide to participant's about their health and quality of life since treatment
Tumor DNA requested from the Biopathology Center
Germline DNA specimens requested from the Biopathology Center or newly collected saliva
Collection and storing of serum/plasma
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Up to 5 years
|
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.
|
Up to 5 years
|
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.
|
Up to 5 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jenny Poynter, PhD, Children's Oncology Group
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Adenocarcinoma
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Pregnancy Complications
- Pregnancy Complications, Neoplastic
- Trophoblastic Neoplasms
- Mesonephroma
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Neoplasms
- Neoplasms, Germ Cell and Embryonal
- Teratoma
- Choriocarcinoma
- Endodermal Sinus Tumor
- Germinoma
- Carcinoma, Embryonal
Other Study ID Numbers
- AEPI17N3
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Teratoma
-
Assistance Publique - Hôpitaux de ParisCompletedSacrococcygeal TeratomaFrance
-
Children's Healthcare of AtlantaTerminated
-
Sohag UniversityRecruitingSacrococcygeal TeratomaEgypt
-
Children's Oncology GroupNational Cancer Institute (NCI)RecruitingChoriocarcinoma | Embryonal Carcinoma | Mixed Germ Cell Tumor | Central Nervous System Nongerminomatous Germ Cell Tumor | Immature Teratoma | Malignant Teratoma | Pineal Region Germ Cell Tumor | Pineal Region Immature Teratoma | Pineal Region Yolk Sac Tumor | Suprasellar Germ Cell TumorUnited States, Australia, Canada, New Zealand
-
Faculdade de Medicina de CatanduvaCompleted
-
Shanghai 10th People's HospitalCompleted
-
Novartis PharmaceuticalsCompletedTeratomaSpain, Netherlands, United States, France
-
University Hospital, MontpellierCompletedVoiding Disorders | Neurogenic Bladder | Sacrococcygeal TeratomaFrance
-
Assistance Publique - Hôpitaux de ParisCompletedCURRARINO Syndrome | Sacrococcygeal Teratoma | Presacral MassFrance
Clinical Trials on Questionnaire Administration
-
Fondazione Don Carlo Gnocchi OnlusUnknown
-
Centre Oscar LambretCentre Hospitalier Universitaire de BesanconTerminated
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI)TerminatedHealth Status UnknownUnited States
-
Istanbul Aydın UniversityCompleted
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingBreast Carcinoma | Fallopian Tube Carcinoma | Endometrial Carcinoma | Ovarian Carcinoma | Primary Peritoneal Carcinoma | Deleterious CDH1 Gene Mutation | Deleterious DICER1 Gene Mutation | Deleterious SMARCA4 Gene Mutation | Deleterious STK11 Gene MutationUnited States
-
Hospital Clínico Universitario de ValladolidRed Centinela Sanitaria de Castilla y León (RCSCYL); Centro Nacional de Gripe... and other collaboratorsRecruitingMigraine | Headache Disorders | Viral Infection | Influenza -Like Illness | Head PainSpain
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RecruitingBreast Ductal Carcinoma In Situ | Invasive Breast Carcinoma | COVID-19 Infection | Hereditary Breast CarcinomaUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingAdvanced Malignant Solid Neoplasm | Recurrent Lymphoma | Recurrent Malignant Solid Neoplasm | Metastatic Malignant Solid Neoplasm | Recurrent Plasma Cell Myeloma | Caregiver | Recurrent LeukemiaUnited States
-
I.M. Sechenov First Moscow State Medical UniversityAgency of Social Information St. PetersburgActive, not recruiting
-
I.M. Sechenov First Moscow State Medical UniversityActive, not recruitingShoulder ArthropathyRussian Federation