Recruiting

NCT Number: NCT03604627

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

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).

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Childhood Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gustave Roussy, Villejuif, Val De Marne, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Inclusion criteria

for extension cohort:

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.

Exclusion criteria

for extension cohort:

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.

Treatment and study plan

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.

Primary outcomes

Incidence of a calcium score

Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Brice FRESNEAU, MD

CONTACT

[email protected]

+33 (0)1 42 11 42 11

Sponsors and collaborators

Lead sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Other

Registry information

Acronym: COROCAN

Important dates

Study start: 2018
Primary completion: 2028
Study completion: 2028
First posted: Jul 27, 2018
Registry last updated: May 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting