SepsisNCT06619535
Sepsis As a Cause of Death Among Elderly Cancer Patients
An observational study of Sepsis and Cancer, run by asmaa salama ibrahim at 1 site in Egypt.
Trial summary
The goal of this retrospective study is to explore the association between sepsis and morality among the elderly cancer patients. Data were extracted from the Surveillance, Epidemiology and End Results( SEER) database using SEER*stat software. Read more about this study
- Who is it for?
- Ages 65 years and older
- How many people
- 5,239,194 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2000to 30 Dec 2021
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: elderly cancer patients
Who may be able to join
- cancer patients
- age 65 year or more
- latency exclusion period of 0 months.
Who cannot join
- Death certificate only and autopsy only cases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sepsis As a Cause of Death Among Elderly Cancer Patients: an Updated SEER Database Analysis 2000-2021
The goal of this retrospective study is to explore the association between sepsis and morality among the elderly cancer patients. Data were extracted from the Surveillance, Epidemiology and End Results( SEER) database using SEER*stat software. The study included patients aged 65 years or more who were diagnosed with cancer from 2000 to 2021. The extracted data included age, race, marital status, sex, stage, surgery, chemotherapy and radiotherapy. Multiple primary session was used to calculate the standardized Mortality ratio (SMR) as Observed/Expected with excess risk/10,000 and significance was achieved at 0.05.
- Keywords
- sepsis, Cancer, mortality, SMR, SEER
- Medical subject headings
- Sepsis, Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
SMR for sepsis as a cause of death among elderly cancer patients
Patients were followed up from the time of diagnosis and the risk was assessed across different time intervals: 1 year, 5 years and +10 years after cancer diagnosis from 2000 to 2021
Measured: from Jan, 2000 till Dec, 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start1 Jan 2000
- Primary completion30 Dec 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies 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
- 5,239,194 participants (actual)
Sponsor and investigators
- Lead sponsor
- asmaa salama ibrahim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, asmaa salama ibrahim, Suez Canal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06619535
- Sponsor's protocol ID
- A273
- Status last verified
- Sep 2024
- First submitted
- 21 Sep 2024
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sepsis As a Cause of Death Among Elderly Cancer Patients: an Updated SEER Database Analysis 2000-2021
- ClinicalTrials.gov ID
- NCT06619535
- Acronym / sponsor ID
- A273
- Keywords
- sepsis, Cancer, mortality, SMR, SEER
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,239,194 participants (actual)
- Lead sponsor
- asmaa salama ibrahimUniversity, hospital or other
- Study start
- 1 Jan 2000 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 1 Oct 2024 (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 retrospective study is to explore the association between sepsis and morality among the elderly cancer patients. Data were extracted from the Surveillance, Epidemiology and End Results( SEER) database using SEER*stat software. The study included patients aged 65 years or more who were diagnosed with cancer from 2000 to 2021. The extracted data included age, race, marital status, sex, stage, surgery, chemotherapy and radiotherapy. Multiple primary session was used to calculate the standardized Mortality ratio (SMR) as Observed/Expected with excess risk/10,000 and significance was achieved at 0.05.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- elderly cancer patients
Key inclusion criteria (3 listed)
- cancer patients
- age 65 year or more
- latency exclusion period of 0 months.
Key exclusion criteria (1 listed)
- Death certificate only and autopsy only cases
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
SMR for sepsis as a cause of death among elderly cancer patients
Time frame: from Jan, 2000 till Dec, 2021
Patients were followed up from the time of diagnosis and the risk was assessed across different time intervals: 1 year, 5 years and +10 years after cancer diagnosis from 2000 to 2021
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 1 Oct 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Sepsis and Cancer, run by asmaa salama ibrahim at 1 site in Egypt.
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 3 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 1 Oct 2024. 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 Egypt. 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?
SMR for sepsis as a cause of death among elderly cancer patients (time frame: from Jan, 2000 till Dec, 2021). 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 1 Oct 2024.