Global Cardio Oncology Registry (G-COR)

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases; Breast Cancer; Cardiotoxicity; Hematologic Malignancy; Immune Checkpoint Inhibitor-Related Myocarditis
• Intervention / Treatment: Other: anonymized data collection during programmed surveillance clinical follow up

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.

G-COR Pilot US, was completed (phase 1) with breast cancer patients from 18 US Centers and enrolled 700 patients.

G-COR Global Phase 2, has now started enrolling patients from the three pillars (-breast cancer, -hematological malignancies, and -patients treated with immune check point inhibitors (ICI). Enrollment of phase 2 started in early 2026 and will continue with enrollment and follow up until July 2029.

G-COR Global International will start in 2026 with centers from Europe, Latin America, Australia, Asia and Africa.

• Study Type: Observational
• Enrollment (Estimated): 5000

Contacts and Locations

• Study Contact: Name: Diego Sadler, MD FACC; Phone Number: 5613898833; Email: sadlerd@ccf.org
• Study Contact Backup: Name: Rohit Moudgil, MD PhD; Phone Number: 216-445-1932; Email: moudgir@ccf.org

Study Locations

• United States
  • Florida
    • Weston, Florida, United States, 33331
      • Recruiting
      • Cleveland Clinic Florida
      • Contact: Diego Sadler, MD FACC; Phone Number: 561-389-8833; Email: sadlerd@ccf.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

As above

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Breast cancer; Patients with breast cancer who present for initial cardio-oncology consultation. Clinical follow up for 18 months.	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
Hematological malignancies; Patients with lymphomas, leukemias, multiple myeloma, and AL amyloidosis who present for initial cardio-oncology consultation. Clinical follow up for 18 months.	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
Immune check point inhibitors; Patients with any type of cancer treated with immune check point inhibitors who present for initial cardio-oncology consultation. Clinical follow for 18 months	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiotoxicity	Any new cardiac event occurring during or after cancer treatment	18 months of prospective follow up
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
Cardiovascular death.	Death during or after cancer treatment, adjudicated to cardiovascular causes by treating physicians.	18 months of prospective follow up

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Principal Investigator: Diego Sadler, MD FACC, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): July 1, 2029

Study Registration Dates

• First Submitted: October 25, 2022
• First Submitted That Met QC Criteria: October 27, 2022
• First Posted (Actual): October 28, 2022

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: cardiotoxicity; Cancer related cardiovascular diseases; prospective registry; international collaboration; social determinants of health; health care disparities; real world data; cardiology-oncology team work
• Additional Relevant MeSH Terms: Wounds and Injuries; Pathologic Processes; Neoplasms by Site; Neoplasms; Heart Diseases; Hematologic Diseases; Chemically-Induced Disorders; Skin Diseases; Breast Diseases; Drug-Related Side Effects and Adverse Reactions; Radiation Injuries; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Hemic and Lymphatic Diseases; Cardiovascular Diseases; Hematologic Neoplasms; Breast Neoplasms; Cardiotoxicity
• Other Study ID Numbers: IRB 22-211

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: To be established by the Scientific committee

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No