RECRUITING

Molecular Epidemiology of Pediatric Germ Cell Tumors

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Conditions

Germ Cell TumorGerminomaTeratomaEmbryonal CarcinomaYolk Sac TumorChoriocarcinomaMixed Germ Cell TumorLate EffectsPediatric Germ Cell Tumor

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Pediatric Germ Cell Tumors: Outcomes, Genomics and Epigenetics

Quick Facts

Study Start:2023-04-12
Study Completion:2027-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05564026

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * 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.
  3. * 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.
  4. * Participants must be able to complete study related documents in English or Spanish.
  5. * 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.
  6. * All institutional, FDA, and NCI requirements for human studies must be met.
  1. * 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

Study Contact

Jenny Poynter
CONTACT
(612) 625-4232
poynt006@umn.edu

Principal Investigator

Jenny Poynter, PhD
PRINCIPAL_INVESTIGATOR
Children's Oncology Group

Study Locations (Sites)

University of Minnesota
Minneapolis, Minnesota, 55455
United States

Collaborators and Investigators

Sponsor: Children's Oncology Group

  • Jenny Poynter, PhD, PRINCIPAL_INVESTIGATOR, Children's Oncology Group

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-12
Study Completion Date2027-06-30

Study Record Updates

Study Start Date2023-04-12
Study Completion Date2027-06-30

Terms related to this study

Additional Relevant MeSH Terms

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