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

Childhood Cancer Clinical Trial

— COROCAN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03604627
• Other study ID #: 2017-A02256-47
• Secondary ID: 2017/2610
• Status: Recruiting
• Phase: N/A
• Start date: June 14, 2018
• Est. completion date: September 2028

Study information

• Verified date: May 2024
• Source: Gustave Roussy, Cancer Campus, Grand Paris
• Contact: Brice FRESNEAU, MD
• Phone: +33 (0)1 42 11 42 11
• Email: brice.fresneau[@]gustaveroussy.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: September 2028
• Est. primary completion date: September 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Childhood Cancer

Intervention

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 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.

Locations

Country	Name	City	State
France	Hôpital Bichat	Paris
France	Hôpital Trousseau	Paris
France	Gustave Roussy	Villejuif	Val De Marne

Sponsors (1)

Lead Sponsor	Collaborator
Gustave Roussy, Cancer Campus, Grand Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of a calcium score	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	Up to 24 months