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| Name | Class |
|---|---|
| Instituto de Investigación Biomédica de Salamanca | OTHER |
| Instituto de Salud Carlos III | OTHER_GOV |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Primary prevention strategy | Experimental | Intensive cardiovascular monitoring focused on prevention and early diagnosis and treatment of cardiotoxicity based in cardio-onco-hematology teams involved in cancer patient care. |
|
| Secondary prevention strategy (control) | Other | Current clinical practice: cardiac care is based on the onco-hematologist criteria. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intensive cardiovascular monitoring | Other | Schedule of visits: Evaluation before starting chemotherapy, at three and six months and annually for five years (eight visits: baseline, 3rd and 6th month, 1st, 2nd, 3rd, 4th and 5th years). Assessment protocol: Anamnesis and physical examination; EKG; Echocardiogram; Biomarkers (troponin and natriuretic peptide); Structured counselling on healthy cardiac practices; Treatment optimization of cardiovascular risk factors and heart diseases; Quality of life (ECOG Performance status and Minnesota questionnaires); Interaction and management of patient care by the cardio-onco-hematology team. Moreover, cardiac MRI in centers participating in the CARTIER-MR sub-study. |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality | Cumulative incidence of all-cause mortality | Two (mid-term analysis) and five years of follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Oncological mortality | Cumulative incidence of oncological mortality | Two and five years of follow-up |
| Cardiovascular mortality | Cumulative incidence of cardiovascular mortality |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pedro L Sánchez, Ph. D. | Contact | 923 291100 | 55356 | plsanchez@saludcastillayleon.es |
| Ana Martín-García, Ph. D. | Contact | 923 291100 | 55356 | amartingarcia@usal.es |
| Name | Affiliation | Role |
|---|---|---|
| Pedro L Sánchez, Ph. D. | IBSAL-Instituto de Investigación Biomédica de Salamanca | Study Director |
| Ana Martín-García, Ph. D. | IBSAL-Instituto de Investigación Biomédica de Salamanca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clínico Universitario de Santiago de Compostela | Not yet recruiting | Santiago de Compostela | A Coruña | 15706 | Spain |
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Randomized, multicenter, open-label clinical trial comparing, in elderly patient with cancer under anti-tumoral treatment, two different cardiotoxicity prevention strategies
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|
| No intervention | Other | Schedule of visits: Evaluation before starting chemotherapy, at three and six months and annually for five years (eight visits: baseline, 3rd and 6th month, 1st, 2nd, 3rd, 4th and 5th years). Assessment protocol: Anamnesis and physical examination; ECOG Performance status; cardiac patient care based on the onco-hematologist criteria |
|
| Two and five years of follow-up |
| Hospitalization | Cumulative incidence of hospitalization | Two and five years of follow-up |
| Hospitalization/emergency cardiovascular cause | Cumulative incidence of hospitalization and/or emergency care for cardiovascular cause | Two and five years of follow-up |
| Hospitalization/emergency cancer cause | Cumulative incidence of hospitalization and/or emergency care for cancer cause | Two and five years of follow-up |
| Tumor recurrence or progression | Incidence of tumoral recurrence or progression | Two and five years of follow-up |
| Hospital de Galdakao-Usansolo | Not yet recruiting | Galdakao | Vizcaya | 48960 | Spain |
|
| Hospital Universitario Vall d´Hebron | Not yet recruiting | Barcelona | 08035 | Spain |
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| Hospital Universitario Reina Sofía | Not yet recruiting | Córdoba | 14004 | Spain |
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| Hospital Universitario de La Princesa | Not yet recruiting | Madrid | 28006 | Spain |
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| Hospital G. Universitario Gregorio Marañón | Not yet recruiting | Madrid | 28009 | Spain |
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| Hospital Universitario Ramón y Cajal | Not yet recruiting | Madrid | 28034 | Spain |
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| Hospital Universitario Fundación Jiménez Díaz | Not yet recruiting | Madrid | 28040 | Spain |
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| Hospital Universitario 12 de Octubre | Not yet recruiting | Madrid | 28041 | Spain |
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| Hospital Universitario Puerta de Hierro | Not yet recruiting | Madrid | 28222 | Spain |
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| Hospital Universitario Virgen de la Victoria | Not yet recruiting | Málaga | 29010 | Spain |
|
| Complejo Asistencial Universitario de Salamanca | Recruiting | Salamanca | 37007 | Spain |
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| Hospital Universitario Virgen del Rocío | Not yet recruiting | Seville | 41013 | Spain |
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| Hospital Universitario Río Hortega | Not yet recruiting | Valladolid | 47012 | Spain |
|
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D003110 | Colonic Neoplasms |
| D001943 | Breast Neoplasms |
| D008223 | Lymphoma |
| D009101 | Multiple Myeloma |
| D066126 | Cardiotoxicity |
| D064419 | Chemically-Induced Disorders |
| D011832 | Radiation Injuries |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D009370 | Neoplasms by Histologic Type |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006474 | Hemorrhagic Disorders |
| D006331 | Heart Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014947 | Wounds and Injuries |
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