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

Gustave Roussy

Status: Enrolling

Conditions: Childhood Cancer

Treatments: Other: Coronal calcium score measurement

Study type: Interventional

Funder types: Other

Identifiers

NCT03604627

2017/2610 (Other Identifier)

2017-A02256-47

Details and patient eligibility

About

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).

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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500 participants in 1 patient group

Patients treated for cancer during childhood or adolescence

Other group

Description:

Patients over the age of 18 treated during childhood or adolescence for cancer with irradiation affecting the heart area (≥20% of ≥5Gy heart volume) and / or anthracyclines (≥ 300mg/m\^²)

Treatment:

Other: Coronal calcium score measurement