Breast CancerG-CORNCT05598879
Global Cardio Oncology Registry
An observational study of Breast Cancer and Hematologic Malignancy, run by The Cleveland Clinic at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Hematologic Malignancy, Immune Checkpoint Inhibitor-Related Myocarditis
- What is being tested?
- anonymized data collection during programmed surveillance clinical follow up
- How many people
- 5,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2022to 1 Jul 2029
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: As above
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cleveland Clinic Florida
Weston, Florida, 33331
Diego Sadler, MD FACC, 561-389-8833, sadlerd@ccf.org
About this study
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.
Read the 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.
- Conditions
- Breast Cancer, Hematologic Malignancy, Immune Checkpoint Inhibitor-Related Myocarditis, Cardiotoxicity, Cardiovascular Diseases
- Being tested
- anonymized data collection during programmed surveillance clinical follow up
- Keywords
- cardiotoxicity, Cancer related cardiovascular diseases, prospective registry, international collaboration, social determinants of health, health care disparities, real world data, cardiology-oncology team work
- Medical subject headings
- Breast Neoplasms, Hematologic Neoplasms, Cardiotoxicity, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anonymized data collection during programmed surveillance clinical follow upOther
anonymized data entry of demographic, clinical, imaging, laboratory, cancer treatment, and cardiovascular events into a RedCap Cloud platform
| Study group | Role | What they receive |
|---|---|---|
| Breast cancer | Patients with breast cancer who present for initial cardio-oncology consultation. Clinical follow up for 18 months. Receives: Other: anonymized data collection during programmed surveillance clinical follow up | |
| Hematological malignancies | Patients with lymphomas, leukemias, multiple myeloma, and AL amyloidosis who present for initial cardio-oncology consultation. Clinical follow up for 18 months. Receives: Other: anonymized data collection during programmed surveillance clinical follow up | |
| 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 Receives: Other: anonymized data collection during programmed surveillance clinical follow up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiotoxicity
Any new cardiac event occurring during or after cancer treatment
Measured: 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.
Measured: 18 months of prospective follow up
Cardiovascular death.
Death during or after cancer treatment, adjudicated to cardiovascular causes by treating physicians.
Measured: 18 months of prospective follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2022
- Study start1 Jul 2022
- Primary completion1 Jul 2029 (estimated)
- Study completion1 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sadler,Diego MD, The Cleveland Clinic
- Investigators
- Diego Sadler, MD FACC, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05598879
- Sponsor's protocol ID
- IRB 22-211
- Acronym
- G-COR
- Status last verified
- May 2026
- First submitted
- 25 Oct 2022
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To be established by the Scientific committee
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Global Cardio Oncology Registry
- ClinicalTrials.gov ID
- NCT05598879
- Acronym / sponsor ID
- G-COR / IRB 22-211
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 Jul 2029 (estimated)
- Study completion
- 1 Jul 2029 (estimated)
- First posted
- 28 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Breast cancer | – | Other: anonymized data collection during programmed surveillance clinical follow upPatients with breast cancer who present for initial cardio-oncology consultation. Clinical follow up for 18 months. |
| Hematological malignancies | – | Other: anonymized data collection during programmed surveillance clinical follow upPatients with lymphomas, leukemias, multiple myeloma, and AL amyloidosis who present for initial cardio-oncology consultation. Clinical follow up for 18 months. |
| Immune check point inhibitors | – | Other: anonymized data collection during programmed surveillance clinical follow upPatients with any type of cancer treated with immune check point inhibitors who present for initial cardio-oncology consultation. Clinical follow for 18 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- As above
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anonymized data collection during programmed surveillance clinical follow upanonymized data entry of demographic, clinical, imaging, laboratory, cancer treatment, and cardiovascular events into a RedCap Cloud platform | Other | Breast cancer, Hematological malignancies, Immune check point inhibitors |
Primary outcome
Cardiotoxicity
Time frame: 18 months of prospective follow up
Any new cardiac event occurring during or after cancer treatment
New cardiovascular events
Time frame: 18 months of prospective follow up
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.
Cardiovascular death.
Time frame: 18 months of prospective follow up
Death during or after cancer treatment, adjudicated to cardiovascular causes by treating physicians.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Individual participant dataSharing planned: No. To be established by the Scientific committee
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Diego Sadler, MD FACC principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Hematologic Malignancy, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Diego Sadler, MD FACC (5613898833, sadlerd@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiotoxicity (time frame: 18 months of prospective follow up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026; AzTrials last refreshed its copy on 30 Oct 2026.