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

NCT ID: NCT03604627

Last Updated: 2024-05-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-14
• Study Completion Date: 2028-09-30

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).

Conditions

Childhood Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Patients treated for cancer during childhood or adolescence

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)

Group Type: OTHER

Coronal calcium score measurement

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

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

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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gustave Roussy, Cancer Campus, Grand Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Gustave Roussy

Villejuif, Val De Marne, France

Site Status: RECRUITING

Hôpital Bichat

Paris, , France

Site Status: RECRUITING

Hôpital Trousseau

Paris, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Brice FRESNEAU, MD

Role: CONTACT

brice.fresneau@gustaveroussy.fr

+33 (0)1 42 11 42 11

Facility Contacts

Brice FRESNEAU, MD

Role: primary

brice.fresneau@gustaveroussy.fr

+33 (0)1 42 11 42 11

Florence Arnoult, MD

Role: primary

florence.arnoult@aphp.fr

+33 (0)1 40 25 84 01

Marie-Dominique Tabone, MD

Role: primary

marie-dominique.tabone@trs.aphp.fr

+33 (0)1 44 73 68 46

Other Identifiers

2017/2610

Identifier Type: OTHER

Identifier Source: secondary_id

2017-A02256-47

Identifier Type: -

Identifier Source: org_study_id