## Protocol Section
### Identification Module
**NCT ID:** NCT05598879

**Acronym:** G-COR

**Brief Title:** Global Cardio Oncology Registry

**Official Title:** Global Cardio Oncology Registry

#### Organization Study ID Info
**ID:** IRB 22-211
#### Organization
**Class:** OTHER
**Full Name:** The Cleveland Clinic
### Status Module
#### Completion Date
**Date:** 2027-07-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-10-28

**Type:** ACTUAL

**Last Update Submit Date:** 2022-10-27

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-07-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2022-07-01

**Type:** ACTUAL

**Status Verified Date:** 2022-10

#### Study First Post Date
**Date:** 2022-10-28
**Type:** ACTUAL
**Study First Submit Date:** 2022-10-25
**Study First Submit QC Date:** 2022-10-27
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** The Cleveland Clinic

#### Responsible Party

**Investigator Affiliation:** The Cleveland Clinic

**Investigator Full Name:** Sadler,Diego

**Investigator Title:** MD FACC Associate Professor of Medicine. CCLCM CWRU

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief 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.

**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.

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 Module

**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

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 5000

**Type:** ESTIMATED

**Patient Registry:** True

**Study Type:** OBSERVATIONAL

**Target Duration:** 18 Months

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

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

**Label:** Breast cancer

#### Arm Group 2

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

**Intervention Names:**

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

**Label:** Hematological malignancies

#### Arm Group 3

**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

**Intervention Names:**

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

**Label:** Immune check point inhibitors

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Breast cancer

- Hematological malignancies

- Immune check point inhibitors

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

**Name:** anonymized data collection during programmed surveillance clinical follow up

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Any new cardiac event occurring during or after cancer treatment

**Measure:** Cardiotoxicity

**Time Frame:** 18 months of prospective follow up

**Description:** 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.

**Measure:** New cardiovascular events

**Time Frame:** 18 months of prospective follow up

**Description:** Death during or after cancer treatment, adjudicated to cardiovascular causes by treating physicians.

**Measure:** Cardiovascular death.

**Time Frame:** 18 months of prospective follow up

### Eligibility Module

**Eligibility Criteria:** 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 Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** As above

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** sadlerd@ccf.org

**Name:** Diego Sadler, MD FACC

**Phone:** 5613898833

**Role:** CONTACT

**Contact 2:**

**Email:** moudgir@ccf.org

**Name:** Rohit Moudgil, MD PhD

**Phone:** 216-445-1932

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Weston

**Contacts:**

***Contact 1:***

- **Email:** sadlerd@ccf.org

- **Name:** Diego Sadler, MD FACC

- **Phone:** 561-389-8833

- **Role:** CONTACT

**Country:** United States

**Facility:** Cleveland Clinic Florida

**State:** Florida

**Status:** RECRUITING

**Zip:** 33331

#### Overall Officials

**Official 1:**

**Affiliation:** The Cleveland Clinic

**Name:** Diego Sadler, MD FACC

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Description:** To be established by the Scientific committee

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009369

- Term: Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000006402

- Term: Hematologic Diseases

- ID: D000006331

- Term: Heart Diseases

- ID: D000010335

- Term: Pathologic Processes

- ID: D000064420

- Term: Drug-Related Side Effects and Adverse Reactions

- ID: D000064419

- Term: Chemically-Induced Disorders

- ID: D000011832

- Term: Radiation Injuries

- ID: D000014947

- Term: Wounds and Injuries

- ID: D000009202

- Term: Cardiomyopathies

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC25

- Name: Substance Related Disorders

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: BC15

- Name: Blood and Lymph Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M5220

- Name: Breast Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M30670

- Name: Cardiotoxicity

- Relevance: HIGH

- As Found: Cardiotoxicity

- ID: M21314

- Name: Hematologic Neoplasms

- Relevance: HIGH

- As Found: Hematologic Malignancies

- ID: M12157

- Name: Myocarditis

- Relevance: HIGH

- As Found: Myocarditis

- ID: M9490

- Name: Hematologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M30303

- Name: Drug-Related Side Effects and Adverse Reactions

- Relevance: LOW

- As Found: Unknown

- ID: M30302

- Name: Chemically-Induced Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14679

- Name: Radiation Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M17685

- Name: Wounds and Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M12154

- Name: Cardiomyopathies

- Relevance: LOW

- As Found: Unknown

- ID: T4005

- Name: Myocarditis

- Relevance: HIGH

- As Found: Myocarditis

### Condition Browse Module - Meshes

- ID: D000019337

- Term: Hematologic Neoplasms

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000066126

- Term: Cardiotoxicity

- ID: D000009205

- Term: Myocarditis

### Intervention Browse Module - Browse Branches

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M2342

- Name: Immune Checkpoint Inhibitors

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
