Time to Initiated Antitumor Therapy for Tumor Patients With COVID19 Infection

COVID-19 Clinical Trial

Official title:

When to Initiation Antitumor Therapy for Tumor Patients With COVID19 Infection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06006845
• Other study ID #: pan-01
• Status: Recruiting
• Start date: December 1, 2022
• Est. completion date: August 31, 2024

Study information

• Verified date: August 2023
• Source: The Seventh Affiliated Hospital of Sun Yat-sen University
• Contact: Xiaofen Pan, MD
• Phone: +8618124671750
• Email: panxf8[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 31, 2024
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Tumor

Locations

Country	Name	City	State
China	Seventh Affiliated Hospital, Sun Yat-sen University	Shenzhen	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
The Seventh Affiliated Hospital of Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Re-infection of COVID-19	Antigen testing or nucleic acid testing positive for COVID-19	28 days after antitumor therapy
Secondary	Clinical manifestations of COVID-19 in tumor patients	Symptoms and lab abnormality of COVID-19 in tumor patients	Until nucleic acid testing turn negative