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Search / Trial NCT06618703

Brain Irradiation for Childhood Cancer - Endocrine Monitoring During the First Years

Launched by UNIVERSITY HOSPITAL, ANGERS · Sep 27, 2024

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Hypothalamic Pituitary Axis Deficiency Cerebral Radiotherapy Brain Tumours Endocrine Monitoring Follow Up Protocol

ClinConnect Summary

The BICHE-1 trial is a study focusing on children and teenagers who have received radiation treatment to their brains for cancer. The main goal of the study is to monitor for potential hormone-related health issues that can arise after such treatment. This is important because radiation can affect the brain areas that control hormones, which are essential for growth, development, and overall well-being. The trial will involve about 100 to 150 patients who are in remission from their cancer and are between the ages of 4 and 18, specifically those who had brain radiation before they turned 16 and are still within five years of completing their treatment.

If your child is eligible, they will participate in regular check-ups with a pediatric endocrinologist, who specializes in hormone-related health. During these visits, doctors will look for any signs of hormone deficiencies and measure fatigue levels using a simple questionnaire. The information gathered will help improve how doctors monitor and support young patients after brain radiation, ultimately aiming to enhance their quality of life. Your consent will be needed for participation, and if you have any questions or concerns, the medical team will be there to help you every step of the way.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Patient aged 4 years or more (≥4) and less than 18 years (\<18) at inclusion
  • Treated with radiotherapy to part or all of the brain for cancer or hematological malignancy before age 16 (≤15)
  • Post-radiotherapy time less than or equal to 5 years (≤5)
  • In remission of this pathology at the end of oncological treatments, or, with stable residual disease without treatment for 2 years or more (≥2)
  • Signature of informed consent from parents or legal guardian
  • Patient affiliated to the social security system or beneficiary of such a system
  • Exclusion Criteria:
  • Patients who have relapsed or developed a second cancer with a post-treatment delay of \< 1 year
  • Patient in palliative situation
  • Brain irradiation with dosimetric data showing sparing of the hypothalamic-pituitary axis (Dmax hypothalamic-pituitary axis \< 15 Gy)
  • Patient with a known hypothalamic-pituitary axis endocrine deficit prior to radiotherapy
  • Refusal of child or parents

About University Hospital, Angers

The University Hospital of Angers is a leading academic medical institution dedicated to advancing healthcare through innovative research and clinical trials. As a prominent sponsor of clinical studies, the hospital leverages its multidisciplinary expertise and state-of-the-art facilities to investigate new therapeutic approaches and improve patient outcomes. Committed to excellence in patient care and medical education, the University Hospital of Angers collaborates with a network of researchers and healthcare professionals to facilitate groundbreaking studies across various medical fields, ensuring rigorous adherence to ethical standards and regulatory compliance. Through its clinical trial initiatives, the institution aims to contribute significantly to the advancement of medical knowledge and the development of effective treatments.

Locations

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported