Time to Initiated Antitumor Therapy for Tumor Patients With COVID19 Infection

NCT06006845 | Unknown

• 1 other identifier: pan-01
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Tumor; COVID-19

Keywords

Tumor patients; COVID-19; antitumor therapy

Outcome Measures

Primary Outcomes (2)

• Incidence of adverse events 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

  Antigen testing or nucleic acid testing positive for COVID-19

  28 days after antitumor therapy

Secondary Outcomes (1)

• Clinical manifestations of COVID-19 in tumor patients

  Until nucleic acid testing turn negative

Study Arms (1)

A

Tumor patients infected with COVID-19

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The Seventh Affiliated Hospital of Sun Yat-sen University: lead

Study Sites (1)

Seventh Affiliated Hospital, Sun Yat-sen University

Shenzhen, Guangdong, 518107, China

RECRUITING

MeSH Terms

Conditions

Neoplasms; COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Bo Wang

  The Seventh Affiliated Hospital of Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaofen Pan, MD

CONTACT

+8618124671750; panxf8@mail.sysu.edu.cn

Bo Wang, MD

CONTACT

0755-81206796; wangb68377@sina.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 22, 2023
• First Posted: August 23, 2023
• Study Start: December 1, 2022
• Primary Completion: February 1, 2023
• Study Completion: August 31, 2024
• Last Updated: August 23, 2023

Record last verified: 2023-08

Locations

CN (1)