Global Cardio Oncology Registry

Breast Cancer Clinical Trial

— G-COR  

Official title:

Global Cardio Oncology Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05598879
• Other study ID #: IRB 22-211
• Status: Recruiting
• Start date: July 1, 2022
• Est. completion date: July 1, 2027

Study information

• Verified date: October 2022
• Source: The Cleveland Clinic
• Contact: Diego Sadler, MD FACC
• Phone: 5613898833
• Email: sadlerd[@]ccf.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: July 1, 2027
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Cardiotoxicity
• Cardiovascular Diseases
• Hematologic Malignancy
• Hematologic Neoplasms
• Myocarditis

Intervention

Other:
• anonymized data collection during programmed surveillance clinical follow up
anonymized data entry of demographic, clinical, imaging, laboratory, cancer treatment, and cardiovascular events into a RedCap Cloud platform

Locations

Country	Name	City	State
United States	Cleveland Clinic Florida	Weston	Florida

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiotoxicity	Any new cardiac event occurring during or after cancer treatment	18 months of prospective follow up
Primary	New cardiovascular events	Heart failure, myocardial infarction, cardiac arrhythmias, syncope, coronary revascularization, heart transplant, cerebrovascular accident, peripheral arterial disease, hypertension, pulmonary hypertension. All events will be adjudicated according to standard clinical definitions.	18 months of prospective follow up
Primary	Cardiovascular death.	Death during or after cancer treatment, adjudicated to cardiovascular causes by treating physicians.	18 months of prospective follow up