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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03604627
Acronym
COROCAN
Enrollment
500
Registered
2018-07-27
Start date
2018-06-14
Completion date
2028-09-30
Last updated
2024-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Childhood Cancer

Brief 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).

Interventions

OTHERCoronal 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.

Sponsors

Gustave Roussy, Cancer Campus, Grand Paris
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Incidence of a calcium scoreUp to 24 monthsIncidence 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

Countries

France

Contacts

Primary ContactBrice FRESNEAU, MD
brice.fresneau@gustaveroussy.fr+33 (0)1 42 11 42 11

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026