NCT03604627 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 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Gustave Roussy, Cancer Campus, Grand Paris |
| Condition | Childhood Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 500 participants |
| Start Date | 2018-06-14 |
| Primary Completion | 2028-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 500 participants in total. It began in 2018-06-14 with a primary completion date of 2028-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT03604627 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Childhood Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03604627 currently recruiting?
Yes, NCT03604627 is actively recruiting participants. Contact the research team at brice.fresneau@gustaveroussy.fr for enrollment information.
Where is the NCT03604627 trial being conducted?
This trial is being conducted at Villejuif, France, Paris, France, Paris, France.
Who is sponsoring the NCT03604627 clinical trial?
NCT03604627 is sponsored by Gustave Roussy, Cancer Campus, Grand Paris. The trial plans to enroll 500 participants.
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