Clinical trial NCT05598879: Global Cardio Oncology Registry
Official title: Global Cardio Oncology Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Hematologic Malignancy
Immune Checkpoint Inhibitor-Related Myocarditis
Cardiotoxicity
Cardiovascular Diseases
Keywords: cardiotoxicity
Cancer related cardiovascular diseases
prospective registry
international collaboration
social determinants of health
health care disparities
real world data
cardiology-oncology team work
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2022-10-28
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: As above

Brief summary: G-COR is the first Global Prospective Cardio-Oncology Registry. It is a multinational, multicenter prospective observational cohort registry, with the goal of collecting clinical, laboratory, imaging, demographic, and socioeconomic data to identify risk factors associated with increased incidence of cancer therapy related cardiovascular toxicity (CTR-CVT) in different settings and to derive and validate risk scores for cardio oncology patients treated in different geographic locations throughout the world.

Detailed description: G-COR is the first Global Prospective Cardio-Oncology Registry. It is a multinational, multicenter prospective observational cohort registry, with the goal of collecting clinical, laboratory, imaging, demographic, and socioeconomic data to identify risk factors associated with increased incidence of cancer therapy related cardiovascular toxicity (CTR-CVT) in different settings and to derive and validate risk scores for cardio oncology patients treated in different geographic locations throughout the world.

G-COR will involve the collaboration from 124 hospitals from 24 countries that completed survey with sites demographics. It will evaluate cardiovascular disease in three distinct populations of cancer patients (hematological malignancies: lymphomas, leukemias, multiple myeloma; breast cancer patients; and patients treated with check point inhibitors immunotherapy).

G-COR will evaluate the cardiovascular impact of different cancer treatments in the above-described patients, and similarities and differences in diagnostic and treatment modalities as well as outcomes and the impact of socioeconomic factors and risk factors for toxicities in a large worldwide population.

G-COR will study the impact of cancer in CV disease in cancer patients treated at academic centers as well as in patients treated at community hospitals, through a systematic prospective data collection in a global digital platform.

G-COR is an IRB approved prospective registry, conducted with the logistical support of C5 Clinical Research Division and the Cardiovascular Outcomes Registries and Research (CORR) group at the Cleveland Clinic and have developed eCRFs with an extensive Red Cap Cloud platform.

G-COR Executive, Scientific and topic committees are led by North American, European, Latin American, Australian and Asian representatives from both academic and community centers.

The pilot phase of G-COR enrolls breast cancer patients only, and the global phase will include all three cohorts of patients (breast, Hem and ICIs).

The investigators have started enrolling patients for G-COR pilot phase with US centers, and will start the global international phase in 2023.

Eligibility criteria: Inclusion Criteria:

* New cardio-oncology consultation for breast cancer patients, or
* New cardio-oncology consultation for Hodgkin's or non-Hodgkin's lymphoma patients, or
* New cardio-oncology consultation for acute or chronic leukemia patients, or
* New cardio-oncology consultation for multiple myeloma or AL amyloidosis, or
* New cardio-oncology consultations for immune check-point inhibitors cardiac evaluation.
* All patients have to be 18 years old or older

Exclusion Criteria:

* Cardio-oncology patients who have previously had cardio-oncology evaluation and follow up by the investigators.
* Minors less than 18 years old.
* Inability or unwillingness to consent to participate

Primary outcomes:
measure: Cardiotoxicity
timeFrame: 18 months of prospective follow up
measure: New cardiovascular events
timeFrame: 18 months of prospective follow up
measure: Cardiovascular death.
timeFrame: 18 months of prospective follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Weston
country: United States
facility: Cleveland Clinic Florida
state: Florida
Study officials:
affiliation: The Cleveland Clinic
name: Diego Sadler, MD FACC
role: PRINCIPAL_INVESTIGATOR
References: