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New treatment option for Obese Patients
Official title KETO-TUMOR: a Study on Brain Tumors and Central Obesity
ClinicalTrials.gov ID: NCT07396896
What this study is testing
- What it's testing
- Hypothalamic-chiasmatic tumours account for 5-10% of CNS tumours in children and can compromise hypothalamic function, causing alterations in energy balance and weight gain. In inoperable cases, chemotherapy and radiotherapy are used; the latter, although the gold standard, is associated with significant neurocognitive and endocrine-metabolic side effects, proportional to the hypothalamic damage.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 7 to 30
You may be able to join if
- Diagnosis of hypothalamic-chiasmatic tumour according to the WHO 2021 classification
- Diagnosis of hypothalamic obesity: after 5 years of age, BMI \>97th percentile in the WHO 2007 curves
- Males and females aged between 7 and 30 years
- Performance status: Lansky score \> 40 for patients aged \ 40 for patients aged between 18 and 30 years
- Signature of informed consent to participate in the study
You likely can't join if
- 1\. Deficiencies of:
- Primary carnitine
- Carnitine palmitoyltransferase 2 (CPT 2)
- Carnitine acylcarnitine translocase (CACT)
- Beta-oxidation
- Medium-chain acyl-CoA dehydrogenase (MCAD)
See the full eligibility criteria
- Diagnosis of hypothalamic-chiasmatic tumour according to the WHO 2021 classification
- Diagnosis of hypothalamic obesity: after 5 years of age, BMI \>97th percentile in the WHO 2007 curves
- Males and females aged between 7 and 30 years
- Performance status: Lansky score \> 40 for patients aged \ 40 for patients aged between 18 and 30 years
- Signature of informed consent to participate in the study
- Signature of consent by the minor patient to participate in the study (7-13 years and 14-17 years).
- 1\. Deficiencies of:
- Primary carnitine
- Carnitine palmitoyltransferase 2 (CPT 2)
- Carnitine acylcarnitine translocase (CACT)
- Beta-oxidation
- Medium-chain acyl-CoA dehydrogenase (MCAD)
- long-chain acyl-CoA dehydrogenase (LCAD)
- short-chain acyl-CoA dehydrogenase (SCAD)
- porphyria
- pyruvate carboxylase
- long-chain 3-hydroxyacyl-CoA dehydrogenase.
The study team makes the final eligibility decision.
Where it's taking place
- Florence, Florence, Italy
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, 7 years to 30 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Florence, Florence, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
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.