Malignant LymphomaNCT05827341
A Real-World Study of COVID-19 Infection in Patients With Malignant Lymphomas Participating in Clinical Trials
An observational study of Malignant Lymphoma and Clinical Trial, run by Sun Yat-sen University at 1 site in China.
Trial summary
This study focuses on the population of malignant lymphoma patients who are also in clinical research. Through a real world cross-sectional survey of infection and death risk during the COVID-19 pandemic in Guangzhou from December 2022 to January 2023, this study aims to clarify the risk, level and mortality of… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Malignant Lymphoma, Clinical Trial, COVID-19
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2022to 15 May 2023
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study focuses on the population of malignant lymphoma patients who are also in clinical research. Through a real world cross-sectional survey of infection and death risk during the COVID-19 pandemic in Sun Yat-Sen University Cancer Center from December 2022 to January 2023, this study aims to clarify the risk, level and mortality of lymphoma patients infected with COVID-19 during their clinical research, and provide necessary research data for Chinese lymphoma patients during the COVID-19 pandemic. We also aimed to identify risk factors of moderate/severe COVID-19 infection and hospital admission.
Who may be able to join
- the diagnosis of lymphoma was confirmed by pathology according to World Health Organization (WHO)-criteria; (2) diagnosed with COVID-19 based on a positive polymerase chain reaction (PCR) test result for SARS-CoV-2 from oropharyngeal swabs, or on a positive detection of covid-19 antigen from nasopharyngeal swabs and typical clinical history; (3) participated in registered clinical trials and received anti-lymphoma treatment within four weeks before COVID-19 infection; (4) complete data on clinico-pathological characteristics, treatment approaches and follow-up were available.
Who cannot join
- Patients who could not provide detailed information about COVID-19 infection.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Medical Oncology, Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, 510060
About this study
This study focuses on the population of malignant lymphoma patients who are also in clinical research. Through a real world cross-sectional survey of infection and death risk during the COVID-19 pandemic in Guangzhou from December 2022 to January 2023, this study aims to clarify the risk, level and mortality of lymphoma patients infected with COVID-19 during their clinical research, and provide necessary research data for Chinese lymphoma patients during the COVID-19 pandemic,
- Conditions
- Malignant Lymphoma, Clinical Trial, COVID-19
- Being tested
- No intervention
- Medical subject headings
- Lymphoma, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention needed
What is being measured
The primary outcome is the main question the study is designed to answer.
The severity of COVID-19
The severity of COVID-19 infection in maligant lymphoma patients evaluated by investigators
Measured: 2 months
Hospital admission rate of COVID-19 infection
The percentage of malignant lymphoma patients who were admitted into hospital
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2023
- Study start1 Dec 2022
- Primary completion31 Jan 2023
- Study completion15 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant LymphomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Zhiming, Sun Yat-sen University
- Investigators
- Zhiming Li, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05827341
- Sponsor's protocol ID
- B2023-075-01
- Status last verified
- Jun 2023
- First submitted
- 22 Apr 2023
- Last updated
- 18 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-World Study of COVID-19 Infection in Patients With Malignant Lymphomas Participating in Clinical Trials
- ClinicalTrials.gov ID
- NCT05827341
- Acronym / sponsor ID
- B2023-075-01
- Conditions
- Malignant Lymphoma, Clinical Trial, COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 15 May 2023 (actual)
- First posted
- 25 Apr 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.
This study focuses on the population of malignant lymphoma patients who are also in clinical research. Through a real world cross-sectional survey of infection and death risk during the COVID-19 pandemic in Guangzhou from December 2022 to January 2023, this study aims to clarify the risk, level and mortality of lymphoma patients infected with COVID-19 during their clinical research, and provide necessary research data for Chinese lymphoma patients during the COVID-19 pandemic,
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study focuses on the population of malignant lymphoma patients who are also in clinical research. Through a real world cross-sectional survey of infection and death risk during the COVID-19 pandemic in Sun Yat-Sen University Cancer Center from December 2022 to January 2023, this study aims to clarify the risk, level and mortality of lymphoma patients infected with COVID-19 during their clinical research, and provide necessary research data for Chinese lymphoma patients during the COVID-19 pandemic. We also aimed to identify risk factors of moderate/severe COVID-19 infection and hospital admission.
Key inclusion criteria (1 listed)
- the diagnosis of lymphoma was confirmed by pathology according to World Health Organization (WHO)-criteria; (2) diagnosed with COVID-19 based on a positive polymerase chain reaction (PCR) test result for SARS-CoV-2 from oropharyngeal swabs, or on a positive detection of covid-19 antigen from nasopharyngeal swabs and typical clinical history; (3) participated in registered clinical trials and received anti-lymphoma treatment within four weeks before COVID-19 infection; (4) complete data on clinico-pathological characteristics, treatment approaches and follow-up were available.
Key exclusion criteria (1 listed)
- Patients who could not provide detailed information about COVID-19 infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention needed | Other | – |
Primary outcome
The severity of COVID-19
Time frame: 2 months
The severity of COVID-19 infection in maligant lymphoma patients evaluated by investigators
Hospital admission rate of COVID-19 infection
Time frame: 2 months
The percentage of malignant lymphoma patients who were admitted into hospital
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- Individual participant dataSharing planned: No
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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.
Zhiming Li principal investigator
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 Malignant Lymphoma and Clinical Trial, run by 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 18 Jun 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The severity of COVID-19 (time frame: 2 months). 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 18 Jun 2023.