Actively Recruiting

Phase Not Applicable
Age: 4Years - 18Years
All Genders
ID06618703

Endocrine Follow-up After Cerebral Radiotherapy Performed Before Age 16 (Direct Cerebral Field or Following Facial, Cervical or High Ear, Nose, and Throat Radiotherapy)

Led by University Hospital, Angers · Updated on 2026-04-06

230

Participants Needed

3

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying endocrine monitoring in children and adolescents who have undergone cerebral radiotherapy for cancer before age 16. The study focuses on patients aged 4 to 18 years who are in remission or have stable residual disease, aiming to improve detection of hormone deficiencies affecting the hypothalamic-pituitary axis and to establish follow-up recommendations that enhance quality of life and health. The trial also explores chronic fatigue as a possible consequence of pituitary deficiencies using an annual fatigue questionnaire. Participants will undergo specific tests including insulin level checks every two years. For children under 8 years old, additional hormone levels such as testosterone, luteinizing hormone, follicle-stimulating hormone, estradiol, inhibin B, and Anti-Müllerian hormone are measured during routine blood tests. Urine tests will be conducted at 2 and 4 years after radiotherapy, and bone density scans will be done twice for patients aged 12 and older, even if the first scan is normal. During the study, patients will be regularly monitored with blood and urine samples and bone densitometry to assess endocrine health and treatment effects over four years, within a maximum of five years post-radiotherapy. Researchers will evaluate hormone deficiencies, fatigue, and cognitive disorders. The study aims to better understand risk factors for pituitary insufficiency and to improve medium-term follow-up care for these patients.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 4Years - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient aged 4 years or more and less than 18 years at inclusion
  • Treated with radiotherapy to part or all of the brain for cancer or hematological malignancy before age 16
  • Time since radiotherapy is less than or equal to 5 years
  • In remission of the disease at the end of oncological treatments, or stable residual disease without treatment for 2 years or more
  • Signed informed consent from parents or legal guardian
  • Patient affiliated with the social security system or beneficiary of such a system
Not Eligible

You will not qualify if you...

  • Patients who have relapsed or developed a second cancer with less than 1 year since treatment
  • Patient in palliative care
  • Brain irradiation that spared the hypothalamic-pituitary axis (maximum dose less than 15 Gy)
  • Known hypothalamic-pituitary axis endocrine deficit before radiotherapy
  • Refusal to participate by the child or parents

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - Up to 5 years post-radiotherapy

Participants undergo endocrine monitoring after cerebral radiotherapy with blood and urine samples and bone density assessments based on age and time since treatment.

Blood tests including insulin every 2 years; urinary check-ups at 2 and 4 years post-radiotherapy; bone densitometry at start and end of follow-up for participants aged 12 and over

Trial Site Locations

Total: 3 locations

1

CHU Angers

Angers, France, 49033

Actively Recruiting

2

Hospices Civils de Lyon

Bron, France, 69500

Actively Recruiting

3

CHU Rennes

Rennes, France, 35023

Actively Recruiting

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Research Team

C

Charlotte Demoor-Goldschmidt, Dr

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

PREVENTION

Number of Arms

1

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