Global Cardio Oncology Registry (G-COR)

NeuroTherapia, Inc.

Status: Enrolling

Conditions: Immune Checkpoint Inhibitor-Related Myocarditis; Cardiotoxicity; Hematologic Malignancy; Breast Cancer; Cardiovascular Diseases

Treatments: Other: anonymized data collection during programmed surveillance clinical follow up

Study type: Observational

Funder types: Other

Identifiers

NCT05598879

IRB 22-211

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

5,000 participants in 3 patient groups

Breast cancer

Description:

Patients with breast cancer who present for initial cardio-oncology consultation. Clinical follow up for 18 months.

Treatment:

Other: anonymized data collection during programmed surveillance clinical follow up

Hematological malignancies

Description:

Patients with lymphomas, leukemias, multiple myeloma, and AL amyloidosis who present for initial cardio-oncology consultation. Clinical follow up for 18 months.

Treatment:

Other: anonymized data collection during programmed surveillance clinical follow up

Immune check point inhibitors

Description:

Patients with any type of cancer treated with immune check point inhibitors who present for initial cardio-oncology consultation. Clinical follow for 18 months

Treatment:

Other: anonymized data collection during programmed surveillance clinical follow up