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Molecular Epidemiology of Pediatric Germ Cell Tumors

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ClinicalTrials.gov Identifier: NCT05564026
Recruitment Status : Recruiting
First Posted : October 3, 2022
Last Update Posted : December 12, 2023
Sponsor:
Information provided by (Responsible Party):
Children's Oncology Group

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Germ Cell Tumor Germinoma Teratoma Embryonal Carcinoma Yolk Sac Tumor Choriocarcinoma Mixed Germ Cell Tumor Late Effects Pediatric Germ Cell Tumor Other: Questionnaire Administration Other: Tumor Specimen Collection Other: Germline DNA Samples Procedure: Blood Sample Collection

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 Design
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Study Type : Observational
Estimated Enrollment : 1151 participants
Observational Model: Family-Based
Time Perspective: Prospective
Official Title: Pediatric Germ Cell Tumors: Outcomes, Genomics and Epigenetics
Actual Study Start Date : April 12, 2023
Estimated Primary Completion Date : June 30, 2027
Estimated Study Completion Date : June 30, 2027

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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.
 Other: Questionnaire Administration
Questionnaire provide to participant's about their health and quality of life since treatment

Other: Tumor Specimen Collection
Tumor DNA requested from the Biopathology Center

Other: Germline DNA Samples
Germline DNA specimens requested from the Biopathology Center or newly collected saliva

Procedure: Blood Sample Collection
Collection and storing of serum/plasma


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Biospecimen Retention:   Samples With DNA
  • Tumor Specimen Collection
  • Germline DNA Samples (saliva)
  • Blood Sample Collection (serum/plasma)

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
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).
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05564026


Locations
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United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Jenny Poynter, PhD    612-625-4232    poynt006@umn.edu   
Sponsors and Collaborators
Children's Oncology Group
Investigators
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Principal Investigator: Jenny Poynter, PhD Children's Oncology Group
More Information
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Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT05564026    
Other Study ID Numbers: AEPI17N3
First Posted: October 3, 2022    Key Record Dates
Last Update Posted: December 12, 2023
Last Verified: December 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms
Neoplasms, Germ Cell and Embryonal
Teratoma
Carcinoma, Embryonal
Endodermal Sinus Tumor
Choriocarcinoma
Germinoma
Neoplasms by Histologic Type
Mesonephroma
 Trophoblastic Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Pregnancy Complications, Neoplastic
Pregnancy Complications
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases