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Trial record 11 of 121 for:    Recruiting, Not yet recruiting, Available Studies | "family history"

Prospective Investigation of Cardiovascular Risk Factors in Tumor Patients

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ClinicalTrials.gov Identifier: NCT03537339
Recruitment Status : Recruiting
First Posted : May 25, 2018
Last Update Posted : June 27, 2018
Sponsor:
Information provided by (Responsible Party):
Fei Ma, Peking Union Medical College

Brief Summary:
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.

Condition or disease Intervention/treatment
Cardioncology Other: Record general information

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Prospective Investigation of Cardiovascular Risk Factors in Tumor Patients
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : December 31, 2020

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




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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03537339


Locations
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China, Beijing
Fei Ma Recruiting
Beijing, Beijing, China, 100021
Contact: Fei Ma, MD    +86-10-87787652    mafei@126.com   
Sponsors and Collaborators
Peking Union Medical College

Additional Information:

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Responsible Party: Fei Ma, Deputy director of medical oncology, Peking Union Medical College
ClinicalTrials.gov Identifier: NCT03537339     History of Changes
Other Study ID Numbers: NCC201712029
First Posted: May 25, 2018    Key Record Dates
Last Update Posted: June 27, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No