Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
5000 participants
OBSERVATIONAL
2022-07-01
2027-07-01
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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
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
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
anonymized data entry of demographic, clinical, imaging, laboratory, cancer treatment, and cardiovascular events into a RedCap Cloud platform
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* Minors less than 18 years old.
* Inability or unwillingness to consent to participate
18 Years
ALL
No
Sponsors
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The Cleveland Clinic
OTHER
Responsible Party
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Sadler,Diego
MD FACC Associate Professor of Medicine. CCLCM CWRU
Principal Investigators
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Diego Sadler, MD FACC
Role: PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Locations
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Cleveland Clinic Florida
Weston, Florida, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IRB 22-211
Identifier Type: -
Identifier Source: org_study_id
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