TumorNCT06006845
Time to Initiated Antitumor Therapy for Tumor Patients With COVID19 Infection
An observational study of Tumor and COVID-19, run by The Seventh Affiliated Hospital of Sun Yat-sen University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2022to 31 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older 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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Seventh Affiliated Hospital, Sun Yat-sen University
Shenzhen, Guangdong, 518107
Xiaofen Pan, MD, +8618124671750, panxf8@mail.sysu.edu.cn
Bo Wang, MD, 0755-81206796, wangb68377@sina.com
About this study
Official title: 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
Read more
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
- Keywords
- Tumor patients, COVID-19, antitumor therapy
- Medical subject headings
- Neoplasms, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| A | Tumor patients infected with COVID-19 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events after antitumor therapy
Incidence of adverse events after antitumor therapy, including hematologic toxicity,gastrointestinal adverse event, hepatobiliary adverse events, etc.
Measured: 28 days after antitumor therapy
Re-infection of COVID-19
Antigen testing or nucleic acid testing positive for COVID-19
Measured: 28 days after antitumor therapy
Secondary outcomes (1)
Clinical manifestations of COVID-19 in tumor patients
Symptoms and lab abnormality of COVID-19 in tumor patients
Measured: Until nucleic acid testing turn negative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start1 Dec 2022
- Primary completion1 Feb 2023
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Seventh Affiliated Hospital of Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang Bo, The Seventh Affiliated Hospital of Sun Yat-sen University
- Investigators
- Bo Wang, Principal investigator, The Seventh Affiliated Hospital of Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06006845
- Sponsor's protocol ID
- pan-01
- Status last verified
- Aug 2023
- First submitted
- 22 Aug 2023
- Last updated
- 23 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- When to Initiation Antitumor Therapy for Tumor Patients With COVID19 Infection
- ClinicalTrials.gov ID
- NCT06006845
- Acronym / sponsor ID
- pan-01
- Keywords
- Tumor patients, COVID-19, antitumor therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The Seventh Affiliated Hospital of Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 23 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | – | –Tumor patients infected with COVID-19 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Re-infection of COVID-19
Time frame: 28 days after antitumor therapy
Antigen testing or nucleic acid testing positive for COVID-19
1 secondary outcome
Clinical manifestations of COVID-19 in tumor patients
Time frame: Until nucleic acid testing turn negative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bo Wang principal investigator
The Seventh Affiliated Hospital of Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tumor and COVID-19, run by The Seventh Affiliated Hospital of Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaofen Pan, MD (+8618124671750, panxf8@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events after antitumor therapy (time frame: 28 days after antitumor therapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2023.