Sepsis As a Cause of Death Among Elderly Cancer Patients | NCT06619535

Studies
Sepsis As a Cause of Death Among Elderly Cancer Patients

NCT06619535

Sponsor

asmaa salama ibrahim

Status

Completed

Last Update Posted

Oct 1, 2024Actual

Enrollment

5,239,194Actual

Phase

Not provided

Conditions

Sepsis
Cancer

Interventions

Not provided

Countries

Egypt

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

Sep 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2000Actual

Primary Completion Date

Dec 30, 2021Actual

Completion Date

Dec 30, 2021Actual

First Submitted Date

Sep 21, 2024

First Submission Date that Met QC Criteria

Sep 27, 2024

First Posted Date

Oct 1, 2024Actual

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

Sep 27, 2024

Last Update Posted Date

Oct 1, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

asmaa salama ibrahim, Resident physician of gastroenterology, Suez Canal UniversitySponsor-Investigator

Lead Sponsor

asmaa salama ibrahimOTHER

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

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

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

5,239,194Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	from Jan, 2000 till Dec, 2021

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

cancer patients
age 65 year or more
latency exclusion period of 0 months.

Exclusion Criteria:

- Death certificate only and autopsy only cases

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

elderly cancer patients

Sampling Method

Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D018805	Sepsis
D009369	Neoplasms

Ancestor Terms

ID	Term
D007239	Infections
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided