Cardiovascular Prevention Strategies in Elderly Patients With Cancer (CARTIER Clinical Trial) (CARTIER)

  • STATUS
    Recruiting
  • End date
    Nov 30, 2025
  • participants needed
    514
  • sponsor
    Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León
Updated on 17 June 2022
cancer
lymphoma
early detection
breast cancer
primary cancer

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

Details
Condition Cancer (Colon Cancer, Breast Cancer, Lymphoma, Chronic Lymphoma Leukemia, Multiple Myeloma), Elderly, Antineoplastic Agents, Cardiotoxicity
Treatment No intervention, Intensive cardiovascular monitoring
Clinical Study IdentifierNCT03711110
SponsorFundación Instituto de Estudios de Ciencias de la Salud de Castilla y León
Last Modified on17 June 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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