Time to Initiated Antitumor Therapy for Tumor Patients With COVID19 Infection

August 22, 2023 updated by: Wang Bo, The Seventh Affiliated Hospital of Sun Yat-sen University

When to Initiation Antitumor Therapy for Tumor Patients With COVID19 Infection

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

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Shenzhen, Guangdong, China, 518107
        • Recruiting
        • Seventh Affiliated Hospital, Sun Yat-sen University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
A
Tumor patients infected with COVID-19

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
28 days after antitumor therapy
Re-infection of COVID-19
Time Frame: 28 days after antitumor therapy
Antigen testing or nucleic acid testing positive for COVID-19
28 days after antitumor therapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Until nucleic acid testing turn negative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Seventh Affiliated Hospital of Sun Yat-sen University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2022

Primary Completion (Actual)

February 1, 2023

Study Completion (Estimated)

August 31, 2024

Study Registration Dates

First Submitted

August 22, 2023

First Submitted That Met QC Criteria

August 22, 2023

First Posted (Actual)

August 23, 2023

Study Record Updates

Last Update Posted (Actual)

August 23, 2023

Last Update Submitted That Met QC Criteria

August 22, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • pan-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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