Time to Initiated Antitumor Therapy for Tumor Patients Wi... | NCT06006845

Studies
Time to Initiated Antitumor Therapy for Tumor Patients With COVID19 Infection

NCT06006845

Sponsor

The Seventh Affiliated Hospital of Sun Yat-sen University

Status

Unknown status

Last Update Posted

Aug 23, 2023Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Tumor
COVID-19

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2022Actual

Primary Completion Date

Feb 1, 2023Actual

Completion Date

Aug 31, 2024Estimated

First Submitted Date

Aug 22, 2023

First Submission Date that Met QC Criteria

Aug 22, 2023

First Posted Date

Aug 23, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 22, 2023

Last Update Posted Date

Aug 23, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Wang Bo, Professor, The Seventh Affiliated Hospital of Sun Yat-sen UniversityPrincipal Investigator

Lead Sponsor

The Seventh Affiliated Hospital of Sun Yat-sen UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Label	Type	Description	Intervention Names
A		Tumor patients infected with COVID-19

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Clinical manifestations of COVID-19 in tumor patients	Symptoms and lab abnormality of COVID-19 in tumor patients	Until nucleic acid testing turn negative

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xiaofen Pan, MD	Contact	+8618124671750		panxf8@mail.sysu.edu.cn
Bo Wang, MD	Contact	0755-81206796		wangb68377@sina.com

Overall Officials

Name	Affiliation	Role
Bo Wang	The Seventh Affiliated Hospital of Sun Yat-sen University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seventh Affiliated Hospital, Sun Yat-sen University	Recruiting	Shenzhen	Guangdong	518107	China

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms
D000086382	COVID-19

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

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Browse Branches

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