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Time to Initiated Antitumor Therapy for Tumor Patients With COVID19 Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06006845
Recruitment Status : Recruiting
First Posted : August 23, 2023
Last Update Posted : August 23, 2023
Sponsor:
Information provided by (Responsible Party):
Wang Bo, The Seventh Affiliated Hospital of Sun Yat-sen University

Study Description
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Brief Summary:

The goal of this observational study is to study the safety of initiation of antitumor therapy early after nucleic acid test turn negativity in tumor patients infected with COVID-19. The main questions aims to answer are:

  • Whether initiation of antitumor therapy early after nucleic acid test turn negativity in tumor patients infected with COVID-19 increases adverse events related to antitumor therapy.
  • Whether initiation of antitumor therapy early after nucleic acid test turn negativity in tumor patients infected with COVID-19 increases risk of re-infection of COVID-19.
  • How initiation of antitumor therapy early after nucleic acid test turn negativity in tumor patients infected with COVID-19 affects QoL of tumor patients

Participants will be asked to answer the question about:

  • the severity and duration of COVID-19 symptoms
  • the date of diagnosis of COVID-19
  • the date of negative nucleic acid test
  • the QoL of life before infection with COVID-19, during infection of COVID-19, after nucleic acid test negativity and receiving antitumor therapy

Condition or disease
Tumor COVID-19

Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: When to Initiation Antitumor Therapy for Tumor Patients With COVID19 Infection
Actual Study Start Date : December 1, 2022
Actual Primary Completion Date : February 1, 2023
Estimated Study Completion Date : August 31, 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
A
Tumor patients infected with COVID-19


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of adverse events after antitumor therapy [ Time Frame: 28 days after antitumor therapy ]
    Incidence of adverse events after antitumor therapy, including hematologic toxicity,gastrointestinal adverse event, hepatobiliary adverse events, etc.

  2. Re-infection of COVID-19 [ Time Frame: 28 days after antitumor therapy ]
    Antigen testing or nucleic acid testing positive for COVID-19


Secondary Outcome Measures :
  1. Clinical manifestations of COVID-19 in tumor patients [ Time Frame: Until nucleic acid testing turn negative ]
    Symptoms and lab abnormality of COVID-19 in tumor patients


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Tumor patients infected with COVID-19 from December 1, 2022 to May 31, and received systemic antitumor therapy after infected with COVID-19.
Criteria

Inclusion Criteria:

  • Tumor patients diagnosed with COVID-19 infection at our center from December 1, 2022 to May 31.
  • COVID-19 was confirmed by antigen testing or nucleic acid testing.
  • Tumor was confirmed by pathology.
  • Patients received systemic antitumor therapy after infected with COVID-19.

Exclusion Criteria:

  • COVID-19 was not confirmed by antigen testing or nucleic acid testing
  • Tumor was not confirmed by pathology
  • Patients did not receive systemic antitumor therapy
  • Patients died before receiving systemic antitumor therapy
Contacts and Locations
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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): NCT06006845


Contacts
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Contact: Xiaofen Pan, MD +8618124671750 panxf8@mail.sysu.edu.cn
Contact: Bo Wang, MD 0755-81206796 wangb68377@sina.com

Locations
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China, Guangdong
Seventh Affiliated Hospital, Sun Yat-sen University Recruiting
Shenzhen, Guangdong, China, 518107
Contact: Xiaofen Pan, MD    +8618124671750    panxf8@mail.sysu.edu.cn   
Contact: Bo Wang, MD    0755-81206796    wangb68377@sina.com   
Sponsors and Collaborators
The Seventh Affiliated Hospital of Sun Yat-sen University
Investigators
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Principal Investigator: Bo Wang The Seventh Affiliated Hospital of Sun Yat-sen University
More Information
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Responsible Party: Wang Bo, Professor, The Seventh Affiliated Hospital of Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT06006845    
Other Study ID Numbers: pan-01
First Posted: August 23, 2023    Key Record Dates
Last Update Posted: August 23, 2023
Last Verified: August 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wang Bo, The Seventh Affiliated Hospital of Sun Yat-sen University:
Tumor patients
COVID-19
antitumor therapy
Additional relevant MeSH terms:
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COVID-19
Infections
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases