NCT03711110 Cardiovascular Prevention Strategies in Elderly Patients With Cancer (CARTIER Clinical Trial)
| NCT ID | NCT03711110 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León |
| Condition | Cancer (Colon Cancer, Breast Cancer, Lymphoma, Chronic Lymphoma Leukemia, Multiple Myeloma) |
| Study Type | INTERVENTIONAL |
| Enrollment | 514 participants |
| Start Date | 2019-08-02 |
| Primary Completion | 2024-08-02 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
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 514 participants in total. It began in 2019-08-02 with a primary completion date of 2024-08-02.
⚠ 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
The CARTIER study is a randomized, multicenter, open-label clinical trial comparing, in elderly patients with cancer under anti-tumoral treatment, two different cardiotoxicity prevention strategies: primary (intensive cardiovascular monitoring focused on prevention and early diagnosis and treatment of cardiotoxicity based in cardio-onco-hematology teams involved in cancer patient care) vs. secondary (current clinical practice where intensive cardiovascular monitoring is not routinely performed and cardiotoxicity patient care is based on the onco-hematologist criteria). The primary endpoint is to determine whether this primary prevention englobing cardiovascular monitoring plus intensive multidisciplinary management is superior to the current clinical practice in reducing all cause mortality. Other secondary objectives of the study are to analyze the impact of this intensive cardiovascular monitoring strategy on the incidence of cardiovascular mortality, oncological mortality, hospitalization and/or urgent care due to cardiovascular complications, hospitalization and/or urgent oncological care due to cancer complications, tumor progression and cost-effectiveness analysis. A total of 514 patients ≥ 65 years old diagnosed with any of the following onco-hematological cancers, colon, breast, lymphoma, chronic lymphoma leukemia, chronic myeloid leukemia or myeloma, undergoing standardized anti-tumoral treatment, will be recruited. The incidence of primary and secondary outcomes will be measured at 2 and 5 years
Eligibility Criteria
Inclusion Criteria: * \> 65 years old * Expected survival \>1 year * Colon cancer, breast cancer, lymphoma, chronic lymphoma leukemia, chronic myeloid leukemia, myeloma * Signature on the informed consent Exclusion Criteria: * Patients included in clinical trials will be excluded if they interfere with the CARTIER follow-up protocol. If they do not interfere they can be included * Patients who had received previous potentially cardiotoxic anticancer treatment
Contact & Investigator
Pedro L Sánchez, Ph. D.
STUDY DIRECTOR
IBSAL-Instituto de Investigación Biomédica de Salamanca
Frequently Asked Questions
Who can join the NCT03711110 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Cancer (Colon Cancer, Breast Cancer, Lymphoma, Chronic Lymphoma Leukemia, Multiple Myeloma). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03711110 currently recruiting?
Yes, NCT03711110 is actively recruiting participants. Contact the research team at plsanchez@saludcastillayleon.es for enrollment information.
Where is the NCT03711110 trial being conducted?
This trial is being conducted at Santiago de Compostela, Spain, Galdakao, Spain, Barcelona, Spain, Córdoba, Spain and 10 additional locations.
Who is sponsoring the NCT03711110 clinical trial?
NCT03711110 is sponsored by Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León. The principal investigator is Pedro L Sánchez, Ph. D. at IBSAL-Instituto de Investigación Biomédica de Salamanca. The trial plans to enroll 514 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.