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

NCT03604627 | Recruiting

• 2 other identifiers: 2017-A02256-472017/2610
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Patients treated for cancer during childhood or adolescence

OTHER

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)

Other: Coronal calcium score measurement

Interventions

Coronal calcium score measurement 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.

Patients treated for cancer during childhood or adolescence

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 18 years of age or older,
• Treated for cancer during childhood, adolescence or young adulthood (≤25 years),
• Treated with irradiation of the heart area (≥20% of ≥5Gy heart rate) and / or anthracycline (cumulative dose of doxorubicin equivalent ≥300mg/m\^²),
• In complete remission of their pediatric cancer for at least 10 years,
• Patient affiliated to a social security scheme or beneficiary of such a scheme,
• Patient Information and Signed Informed Consent.

You may not qualify if:

• Perspective less than 10 years,
• Persons deprived of liberty or guardianship (including trusteeship),
• Impossibility of submitting to the medical follow-up of the test for geographical, social or psychological reasons,
• Pregnant women.
• Patients 30 years of age or older,
• Treated for cancer during childhood, adolescence or young adulthood (≤25 years),
• Treated with irradiation of the heart area (≥20% of ≥5Gy heart rate),
• In complete remission of their pediatric cancer for at least 10 years,
• Patient affiliated to a social security scheme or beneficiary of such a scheme,
• Patient Information and Signed Informed Consent.
• Persons deprived of liberty or guardianship (including trusteeship),
• Impossibility of submitting to the medical follow-up of the test for geographical, social or psychological reasons,
• Pregnant women.

Sponsors & Collaborators

• Gustave Roussy, Cancer Campus, Grand Paris: lead

Study Sites (3)

Gustave Roussy

Villejuif, Val De Marne, 94805, France

RECRUITING

Hôpital Bichat

Paris, France

RECRUITING

Hôpital Trousseau

Paris, France

RECRUITING

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Brice FRESNEAU, MD

CONTACT

+33 (0)1 42 11 42 11; brice.fresneau@gustaveroussy.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2018
• First Posted: July 27, 2018
• Study Start: June 14, 2018
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: May 29, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)