Measuring heart calcium levels in adults treated for childhood cancer

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

This study is testing if adults who had radiation therapy for childhood cancer have higher heart calcium levels compared to others, to see if the treatment affects their heart health.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 500 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris (Academic / other)
• Drugs / interventions: doxorubicin
• Locations: 3 sites (Villejuif, Val De Marne and 2 other locations)
• Trial ID: NCT03604627 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the coronary calcium score in adults who received radiation therapy to the heart area during childhood or adolescence for cancer treatment. It will compare the calcium scores of these individuals to assess whether radiation exposure is linked to increased calcium levels, while adjusting for other cardiovascular risk factors such as age, sex, and pre-existing conditions. The study focuses on patients who have been in complete remission for at least 10 years and are now adults. The primary intervention involves measuring the coronary calcium score using imaging techniques.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who were treated for cancer during childhood with heart irradiation or anthracycline therapy and have been in remission for at least 10 years.

Not a fit: Patients who have not been in remission for at least 10 years or those who have not received heart irradiation or anthracycline treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could help identify cardiovascular risks in survivors of childhood cancer, leading to better monitoring and preventive strategies.

How similar studies have performed: Other studies have indicated potential links between radiation therapy and cardiovascular issues, suggesting that this approach may yield valuable insights.

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.

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.

Where this trial is running

Villejuif, Val De Marne and 2 other locations

• Gustave Roussy — Villejuif, Val De Marne, France (Recruiting)
• Hôpital Bichat — Paris, France (Recruiting)
• Hôpital Trousseau — Paris, France (Recruiting)

Study contacts

• Study coordinator: Brice FRESNEAU, MD

Conditions Childhood Cancer