Study of Coronary Calcium Score as a Marker of Post-radiation Vascular Dysplasia in Adults Treated During Childhood for Cancer With Mediastinal Irradiation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Coronal calcium score measurement.
- Who it may be relevant to
- Registry conditions: Childhood Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
To measure coronary calcium score in adults treated during childhood or adolescence for irradiation cancer in the heart and / or anthracycline area and compare them to determine whether irradiation of the heart area is associated with increased calcium score after adjustment for other cardiovascular risk factors (age, sex, smoking, dyslipidemia, obesity, diabetes, high blood pressure and renal failure).
Interventions
- Other Coronal calcium score measurement
A medical interview with clinical examination by a cardiologist for screening cardiovascular risk factors, including smoking, and looking for symptoms of heart disease as part of routine care. In accordance with routine care, a fasting and fasting blood test will be performed performed on exam day at Bichat Hospital or at another time, close to the patient's home according to his availability. The biological blood test will include the measurement of plasma triglyceride concentrations, total ch
Primary outcome measures
- Incidence of a calcium score [Time frame: Up to 24 months]
Eligibility criteria
Inclusion criteria
- Patients 18 years of age or older,
- Treated for cancer during childhood, adolescence or young adulthood (≤25 years),
- Treated with irradiation of the heart area (≥20% of ≥5Gy heart rate) and / or anthracycline (cumulative dose of doxorubicin equivalent ≥300mg/m\^²),
- In complete remission of their pediatric cancer for at least 10 years,
- Patient affiliated to a social security scheme or beneficiary of such a scheme,
- Patient Information and Signed Informed Consent.
Exclusion criteria
- Perspective less than 10 years,
- Persons deprived of liberty or guardianship (including trusteeship),
- Impossibility of submitting to the medical follow-up of the test for geographical, social or psychological reasons,
- Pregnant women.
Inclusion criteria for extension cohort:
- Patients 30 years of age or older,
- Treated for cancer during childhood, adolescence or young adulthood (≤25 years),
- Treated with irradiation of the heart area (≥20% of ≥5Gy heart rate),
- In complete remission of their pediatric cancer for at least 10 years,
- Patient affiliated to a social security scheme or beneficiary of such a scheme,
- Patient Information and Signed Informed Consent.
Exclusion criteria for extension cohort:
- Persons deprived of liberty or guardianship (including trusteeship),
- Impossibility of submitting to the medical follow-up of the test for geographical, social or psychological reasons,
- Pregnant women.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
France · 3 centers
- Gustave Roussy — Villejuif
- Hôpital Bichat — Paris
- Hôpital Trousseau — Paris
Identifiers
NCT: NCT03604627 · 2017-A02256-47 · 2017/2610