Global Cardio Oncology Registry

NCT05598879 | Recruiting DMC

• 1 other identifier: IRB 22-211
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

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

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

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

Interventions

anonymized data collection during programmed surveillance clinical follow up OTHER

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

Breast cancer; Hematological malignancies; Immune check point inhibitors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

As above

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic Florida

Weston, Florida, 33331, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Hematologic Neoplasms; Cardiotoxicity; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries

Study Officials

• Diego Sadler, MD FACC

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Diego Sadler, MD FACC

CONTACT

5613898833; sadlerd@ccf.org

Rohit Moudgil, MD PhD

CONTACT

216-445-1932; moudgir@ccf.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 18 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD FACC Associate Professor of Medicine. CCLCM CWRU

Study Record Dates

• First Submitted: October 25, 2022
• First Posted: October 28, 2022
• Study Start: July 1, 2022
• Primary Completion: July 1, 2025
• Study Completion (Estimated): July 1, 2027
• Last Updated: October 28, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)