Molecular Epidemiology of Pediatric Germ Cell Tumors

Trial Title: Molecular Epidemiology of Pediatric Germ Cell Tumors

NCT ID: NCT05564026

Condition: Germ Cell Tumor
Germinoma
Teratoma
Embryonal Carcinoma
Yolk Sac Tumor
Choriocarcinoma
Mixed Germ Cell Tumor
Late Effects
Pediatric Germ Cell Tumor

Conditions: Official terms:
Neoplasms
Neoplasms, Germ Cell and Embryonal
Teratoma
Endodermal Sinus Tumor
Carcinoma, Embryonal
Choriocarcinoma
Germinoma

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Other
Intervention name: Questionnaire Administration
Description: Questionnaire provide to participant's about their health and quality of life since treatment
Arm group label: Ancillary-Correlative

Intervention type: Other
Intervention name: Tumor Specimen Collection
Description: Tumor DNA requested from the Biopathology Center
Arm group label: Ancillary-Correlative

Intervention type: Other
Intervention name: Germline DNA Samples
Description: Germline DNA specimens requested from the Biopathology Center or newly collected saliva
Arm group label: Ancillary-Correlative

Intervention type: Procedure
Intervention name: Blood Sample Collection
Description: Collection and storing of serum/plasma
Arm group label: Ancillary-Correlative

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.

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.

Criteria for eligibility:

Study pop:
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).

Sampling method: Non-Probability Sample
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

Gender: All

Minimum age: N/A

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: University of Minnesota

Address:
City: Minneapolis
Zip: 55455
Country: United States

Status: Recruiting

Contact:
Last name: Jenny Poynter, PhD

Phone: (612) 625-4232
Email: poynt006@umn.edu

Start date: April 12, 2023

Completion date: June 30, 2027

Lead sponsor:
Agency: Children's Oncology Group
Agency class: Other

Source: Children's Oncology Group

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05564026