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New treatment option for Endocrine; Deficiency
Official title Brain Irradiation for Childhood Cancer - Endocrine Monitoring During the First Years
ClinicalTrials.gov ID: NCT06618703
What this study is testing
- What it's testing
- BICHE- 1: Brain Irradiation for Childhood cancer - Endocrine monitoring during the first five years is a study of endocrine monitoring after cerebral radiotherapy. The study concerns patients in remission at the end of oncological treatment aged between 4 and 18 years at the time of inclusion and who have had radiotherapy before the age of 16, irradiating all or part of the brain, with a delay between the end of radiotherapy and inclusion of less than 5 years.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 4 to 18
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Angers, France
- Bron, France
- Rennes, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 4 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Angers, France; Bron, France; Rennes, France. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.