Study of Coronary Calcium Score as a Marker of Post-radiation Vascular Dysplasia in Adults Treated During Childhood for Cancer With Mediastinal Irradiation

NCT03604627 · tracked via the Priya Life Science France tracker

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Phase

Not applicable

Started

2018-06-14

Last updated

2024-05-29

Condition(s) studied

Childhood Cancer

Investigational drug(s) / intervention(s)

Coronal calcium score measurement

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 cholesterol and its HDL and LDL fractions, blood glucose, glycated hemoglobin and serum creatinine with estimated glomerular filtration rate according to the CKD-EPI formula. Sample urinalysis will include measurement of creatinine, proteinuria, and microalbuminuria. An electrocardiogram (ECG) rest, a cardiac ultrasound, a test and respiratory function tests (EFR) will be performed as part of routine care. Coronal calcium score measurement will be performed as part of the research.

Study summary

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).

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: 1. Patients 18 years of age or older, 2. Treated for cancer during childhood, adolescence or young adulthood (≤25 years), 3. Treated with irradiation of the heart area (≥20% of ≥5Gy heart rate) and / or anthracycline (cumulative dose of doxorubicin equivalent ≥300mg/m\^²), 4. In complete remission of their pediatric cancer for at least 10 years, 5. Patient affiliated to a social security scheme or beneficiary of such a scheme, 6. Patient Information and Signed Informed Consent. Exclusion Criteria: 1. Perspective less than 10 years, 2. Persons deprived of liberty or guardianship (including trusteeship), 3. Impossibility of submitting to the medical follow-up of the test for geographical, social or psychological reasons, 4. Pregnant women. Inclusion criteria for extension cohort: 1. Patients 30 years of age or older, 2. Treated for cancer during childhood, adolescence or young adulthood (≤25 years), 3. Treated with irradiation of the heart area (≥20% of ≥5Gy heart rate), 4. In complete remission of their pediatric cancer for at least 10 years, 5. Patient affiliated to a social security scheme or beneficiary of such a scheme, 6. Patient Information and Signed Informed Consent. Exclusion criteria for extension cohort: 1. Persons deprived of liberty or guardianship (including trusteeship), 2. Impossibility of submitting to the medical follow-up of the test for geographical, social or psychological reasons, 3. Pregnant women.

Primary outcome measure(s)

Incidence of a calcium score — Up to 24 months
Incidence of a calcium score measured by the Agatston score\> 0 in the study population of adults treated during childhood or adolescence for cancer with irradiation of the heart area and / or treatment with anthracyclines

Trial sites (3)

Facility	City	Region	Status
Gustave Roussy	Villejuif	Val De Marne	Recruiting
Hôpital Bichat	Paris	France	Recruiting
Hôpital Trousseau	Paris	France	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03604627 on ClinicalTrials.gov ↗ ← All trials in France