Prospective Investigation of Cardiovascular Risk Factors in Tumor Patients

In this study, prospective cohort study was used to collect the general information of patients' sex, age, previous history, family history, electrocardiogram, echocardiography, cardiac biomarkers TnT, BNP, biochemical examination, and clinical treatment of the patients who diagnosed cancer by pathology in National Cancer Center/ Cancer Hospital , Chinese Academy of Medical Sciences and Peking Union Medical College from January 2018 to December 2020. This study intends to evaluate and screen the cardiovascular risk of tumor patients during antitumor therapy and to establish a model of cardiovascular risk assessment for tumor patients, providing clinical evidence for the prevention of cardiovascular disease risk associated with cancer patients.

Study Overview

• Status: Unknown
• Conditions: Cardioncology
• Intervention / Treatment: Other: Record general information

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100021
      • Recruiting
      • Fei Ma
      • Contact: Fei Ma, MD; Phone Number: +86-10-87787652; Email: mafei@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Diagnosed cancer by pathology in National Cancer Center/ Cancer Hospital , Chinese Academy of Medical Sciences and Peking Union Medical College from January 2018 to December 2020

Description

Inclusion Criteria:

1. Diagnosis of malignant tumor by pathology or cytology
2. Age 18-80, KPS > 70
3. Epidemiological information, clinical diagnosis and treatment and key information of medication are not missing.
4. The liver and kidney function were in the normal range.
5. All selected patients signed informed consent.

Exclusion Criteria:

1. patients diagnosed with congenital heart disease, cardiomyopathy, heart failure, arrhythmia, myocardial ischemia and myocardial infarction within 6 months before enrollment.
2. Severe impairment of liver and kidney function.
3. Left ventricular ejection fraction < 50% by echocardiographic examination.
4. Diagnosis of more than one kind of tumor at the same time.
5. History of surgery and trauma within 3 months before enrollment.
6. Poor compliance

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Observation; Record general information of patients' sex, age, previous history, family history, electrocardiogram, echocardiography, cardiac biomarkers TnT, BNP, biochemical examination, and clinical treatment and so on	Other: Record general information; Record general information of patients' sex, age, previous history, family history, electrocardiogram, echocardiography, cardiac biomarkers TnT, BNP, biochemical examination, and clinical treatment of the patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events (AEs) related to Cardio-oncology	Adverse events (AEs) and laboratory tests graded according to the NCI CTCAE (version 4.0) recorded by ECGs,UCGs and myocardial enzyme	January 2018 to December 2020.

Collaborators and Investigators

• Sponsor: Peking Union Medical College

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Anticipated): September 30, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: May 15, 2018
• First Submitted That Met QC Criteria: May 15, 2018
• First Posted (Actual): May 25, 2018

Study Record Updates

• Last Update Posted (Actual): June 27, 2018
• Last Update Submitted That Met QC Criteria: June 25, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: NCC201712029

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No