Evaluating the Risk of Postoperative Venous Thromboemboli... | NCT06556953

Studies
Evaluating the Risk of Postoperative Venous Thromboembolism in Cervical Cancer Patients

NCT06556953

Sponsor

Haike Lei

Status

Completed

Last Update Posted

Aug 16, 2024Actual

Enrollment

1,174Actual

Phase

Not provided

Conditions

Venous Thromboembolism

Interventions

Not provided

Countries

China

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

Aug 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, 2019Actual

Primary Completion Date

Dec 31, 2023Actual

Completion Date

Dec 31, 2023Actual

First Submitted Date

Aug 6, 2024

First Submission Date that Met QC Criteria

Aug 15, 2024

First Posted Date

Aug 16, 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

Aug 15, 2024

Last Update Posted Date

Aug 16, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of this study is to develop a machine learning model to accurately predict the risk of venous thromboembolism in patients with cervical cancer after surgery.

Detailed Description

Venous thromboembolism (VTE) is a common and life-threatening complication in patients with cervical cancer following surgery. The objective of this study is to develop a machine learning model with the potential to predict the risk of VTE in these patients postoperatively. We plan to employ partial dependence (PD) curves, breakdown (BD) curves, Ceteris-paribus (CP), and SHapley additive exPlanations (SHAP) values for a comprehensive analysis. The goal is to explore how different machine learning algorithms can be utilized as tools for personalized postoperative VTE risk assessment in cervical cancer patients.

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

1,174Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Whether the patient has developed VTE is determined based on the diagnostic criteria in the "Guidelines for the Prevention and Treatment of Tumor-Associated Venous Thromboembolism (2019 Edition)."	The diagnosis of VTE primarily includes the diagnosis of DVT and PE. According to the guidelines, DVT is diagnosed using venous compression ultrasound or venography, while PE is diagnosed using CT pulmonary angiography (CTPA) or nuclear lung ventilation/perfusion imaging.	December 31, 2023

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Confirmation of cervical cancer through pathological examination.
Receipt of surgical treatment for cervical cancer at Chongqing University Cancer Hospital in China.
Provision of comprehensive case information.

Exclusion Criteria:

Patients under the age of 18.
History of VTE caused by other reasons before surgery.
Secondary cervical cancer or accompanying primary malignant tumor.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

89 Years

Standard Ages

AdultOlder Adult

Study Population

Our data was collected from electronic case of the cervical cancer patients who underwent surgical treatment at the Cancer Hospital affiliated with Chongqing University between January 2019 and December 2022

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chongqing University Cancer Hospital		Chongqing	Chongqing Municipality	400030	China

Condition Browse Module

MeSH Terms

ID	Term
D054556	Venous Thromboembolism
D002583	Uterine Cervical Neoplasms

Ancestor Terms

ID	Term
D013923	Thromboembolism
D016769	Embolism and Thrombosis
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided