SARS CoV 2 InfectionNCT05240378
Mortality of Cancer Surgery During SARS CoV2 Pandemic
An observational study of SARS CoV 2 Infection and Cancer, run by Banaras Hindu University at 1 site in India.
Trial summary
The impact of cancer surgery during covid epidemic is not clear. The published reports show contradictory findings that extend from no change in mortality to increased mortality, further no data on exposure and outcome of health care worker is available. This study is designed to address the above questions Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- SARS CoV 2 Infection, Cancer
- What is being tested?
- Surgery
- How many people
- 1,576 participants
- Where
- 1 siteIndia
- Study dates
- 29 Oct 2021to 15 Jan 2022
- 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 99 years
- All sexes
- Adult, Older adult
Study population: All cases of cancer operated between April 2019 to May 2021
Who may be able to join
- All patients operated during the study period
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preoperative Screening for COVID-19 and Strict COVID Cancer Protocol Helps to Reduce Postoperative Infection, Mortality and Morbidity in Cancer Patients Undergoing Surgery. A Comparative Study
The impact of cancer surgery during covid epidemic is not clear. The published reports show contradictory findings that extend from no change in mortality to increased mortality, further no data on exposure and outcome of health care worker is available. This study is designed to address the above questions
Read the detailed description
This is a retrospective study from the prospectively collected data that is extracted from the electronic database of Department of Surgical Oncology, IMS, BHU The data is inform of two cohorts one extending from April 2019-April 2020 and other from May 2020 to May 2021 i.e. pre covid and during covid pandemic
- Conditions
- SARS CoV 2 Infection, Cancer
- Being tested
- Surgery
- Medical subject headings
- COVID-19, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgeryOther
Surgery for cancer as per the stage of the disease and protocol
| Study group | Role | What they receive |
|---|---|---|
| Pre covid | Cases operated one year prior to the date of declaration of corona pandemic in India Receives: Other: Surgery | |
| post covid | cases operated from the date of declaration of corona pandemic to one year after Receives: Other: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
30 day mortality
post operative deaths within one year
Measured: 30 days
number of participants developing major or minor complications
Surgical complications classified as per Clavien Dindo classification
Measured: 30 days
Secondary outcomes (1)
number of health care worker with SARS CoV2 infection
Covid infection in health care workers
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2022
- Study start29 Oct 2021
- Primary completion31 Dec 2021
- Study completion15 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS CoV 2 InfectionStudies 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
- 1,576 participants (actual)
Sponsor and investigators
- Lead sponsor
- Banaras Hindu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manoj Pandey, Banaras Hindu University
- Investigators
- Manoj Pandey, MS, PhD, Principal investigator, Banaras Hindu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05240378
- Sponsor's protocol ID
- Dean/2021/EC/3004
- Status last verified
- Feb 2022
- First submitted
- 12 Feb 2022
- Last updated
- 3 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD will be shared on reasonable request as per Indian law
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Screening for COVID-19 and Strict COVID Cancer Protocol Helps to Reduce Postoperative Infection, Mortality and Morbidity in Cancer Patients Undergoing Surgery. A Comparative Study
- ClinicalTrials.gov ID
- NCT05240378
- Acronym / sponsor ID
- Dean/2021/EC/3004
- Conditions
- SARS CoV 2 Infection, Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,576 participants (actual)
- Lead sponsor
- Banaras Hindu UniversityUniversity, hospital or other
- Study start
- 29 Oct 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 15 Jan 2022 (actual)
- First posted
- 15 Feb 2022 (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 impact of cancer surgery during covid epidemic is not clear. The published reports show contradictory findings that extend from no change in mortality to increased mortality, further no data on exposure and outcome of health care worker is available. This study is designed to address the above questions
Detailed description
This is a retrospective study from the prospectively collected data that is extracted from the electronic database of Department of Surgical Oncology, IMS, BHU The data is inform of two cohorts one extending from April 2019-April 2020 and other from May 2020 to May 2021 i.e. pre covid and during covid pandemic
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre covid | – | Other: SurgeryCases operated one year prior to the date of declaration of corona pandemic in India |
| post covid | – | Other: Surgerycases operated from the date of declaration of corona pandemic to one year after |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All cases of cancer operated between April 2019 to May 2021
Key inclusion criteria (1 listed)
- All patients operated during the study period
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| SurgerySurgery for cancer as per the stage of the disease and protocol | Other | Pre covid, post covid |
Primary outcome
30 day mortality
Time frame: 30 days
post operative deaths within one year
number of participants developing major or minor complications
Time frame: 30 days
Surgical complications classified as per Clavien Dindo classification
1 secondary outcome
number of health care worker with SARS CoV2 infection
Time frame: 1 year
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 3 Mar 2022.
- Individual participant dataSharing planned: Undecided. IPD will be shared on reasonable request as per Indian law
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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.
Manoj Pandey, MS, PhD principal investigator
Banaras Hindu 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 SARS CoV 2 Infection and Cancer, run by Banaras Hindu University at 1 site in India.
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 3 Mar 2022. 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 India. 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?
30 day mortality (time frame: 30 days). 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 3 Mar 2022.