Molecular Epidemiology of Pediatric Germ Cell Tumors

Launched by CHILDREN'S ONCOLOGY GROUP · Sep 29, 2022

Keywords

ClinConnect Summary

This clinical trial, titled "Molecular Epidemiology of Pediatric Germ Cell Tumors," is focused on understanding the effects of treatment on children who have survived germ cell tumors (GCT). GCTs are a type of tumor that can develop in different parts of the body, including the brain, and can come in various forms, such as germinoma, teratoma, and yolk sac tumors. The study aims to gather information about both the short-term and long-term challenges that survivors may face after treatment. By analyzing biological samples from these patients, researchers hope to improve how we assess the risk of these tumors and their treatments in the future.

To be eligible for this study, participants must have been diagnosed with a germ cell tumor before the age of 20 and be enrolled in specific previous studies. Those who can participate include anyone who can fill out study-related documents in English or Spanish. Participants, along with their parents or guardians, will need to give consent to join the study, and younger participants between 8 and 17 years old will also need to agree with their parents' approval. Throughout the study, survivors will be monitored over time, allowing researchers to gather valuable information about their health and well-being. This trial is currently recruiting participants, and it is an important step in understanding how to better support young patients who have faced these challenging tumors.

Gender

ALL

Eligibility 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