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Time to Initiated Antitumor Therapy for Tumor Patients With COVID19 Infection

Sponsor
The Seventh Affiliated Hospital of Sun Yat-sen University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06006845
Collaborator
(none)
100
Enrollment
1
Location
21
Anticipated Duration (Months)
4.8
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated 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 :
    Dec 1, 2022
    Actual Primary Completion Date :
    Feb 1, 2023
    Anticipated Study Completion Date :
    Aug 31, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    A

    Tumor patients infected with COVID-19

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of adverse events after antitumor therapy [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 [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 [Until nucleic acid testing turn negative]

      Symptoms and lab abnormality of COVID-19 in tumor patients

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Seventh Affiliated Hospital, Sun Yat-sen University Shenzhen Guangdong China 518107

    Sponsors and Collaborators

    • The Seventh Affiliated Hospital of Sun Yat-sen University

    Investigators

    • Principal Investigator: Bo Wang, The Seventh Affiliated Hospital of Sun Yat-sen University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    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:
    Aug 23, 2023
    Last Update Posted:
    Aug 23, 2023
    Last Verified:
    Aug 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Wang Bo, Professor, The Seventh Affiliated Hospital of Sun Yat-sen University
    Tumor patients
    COVID-19
    antitumor therapy
    Additional relevant MeSH terms:
    COVID-19

    Study Results

    No Results Posted as of Aug 23, 2023