Global Cardio Oncology Registry

NCT ID: NCT05598879

Last Updated: 2022-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

5000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-01

Study Completion Date

2027-07-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Breast cancer

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

anonymized data collection during programmed surveillance clinical follow up

Intervention Type OTHER

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.

anonymized data collection during programmed surveillance clinical follow up

Intervention Type OTHER

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

anonymized data collection during programmed surveillance clinical follow up

Intervention Type OTHER

anonymized data entry of demographic, clinical, imaging, laboratory, cancer treatment, and cardiovascular events into a RedCap Cloud platform

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The Cleveland Clinic

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Sadler,Diego

MD FACC Associate Professor of Medicine. CCLCM CWRU

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Diego Sadler, MD FACC

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Cleveland Clinic Florida

Weston, Florida, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Diego Sadler, MD FACC

Role: CONTACT

5613898833

Rohit Moudgil, MD PhD

Role: CONTACT

216-445-1932

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Diego Sadler, MD FACC

Role: primary

561-389-8833

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IRB 22-211

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Cardiology Biobank Registry
NCT00378924 RECRUITING