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

Not Applicable

Recruiting

• Conditions: Childhood Cancer
• Interventions: Other: Coronal calcium score measurement

• Registration Number: NCT03604627
• Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-14
• Study First Submitted: 2018-07-20
• Study First Submitted QC: 2018-07-20
• Study First Posted: 2018-07-27
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-28
• Last Update Posted: 2024-05-29
• Primary Completion: 2028-09
• Study Completion: 2028-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients treated for cancer during childhood or adolescence	Coronal calcium score measurement	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)

Primary Outcome Measures

Name	Time	Method
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 Locations

Locations (3)

Hôpital Bichat; 🇫🇷 Paris, France

Gustave Roussy; 🇫🇷 Villejuif, Val De Marne, France

Hôpital Trousseau; 🇫🇷 Paris, France