A Comparative Analysis of Ultrasound's Accuracy in Diagno... | NCT06748755

Studies
A Comparative Analysis of Ultrasound's Accuracy in Diagnosing HC Using Histopathology as Gold Standard

NCT06748755

Sponsor

Superior University

Status

Active, not recruiting

Last Update Posted

Dec 27, 2024Actual

Enrollment

90Actual

Phase

Not provided

Conditions

Hepatocellular Carcinoma

Interventions

Group 1

Countries

Pakistan

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

Dec 2024

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2024Actual

Primary Completion Date

Sep 1, 2024Actual

Completion Date

Feb 20, 2025Estimated

First Submitted Date

Dec 19, 2024

First Submission Date that Met QC Criteria

Dec 19, 2024

First Posted Date

Dec 27, 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

Dec 19, 2024

Last Update Posted Date

Dec 27, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 study aims to evaluate the accuracy of ultrasound in diagnosing hepatocellular carcinoma (HCC), using histopathology as the gold standard. It addresses HCC's high global incidence and the utility of ultrasound as a non-invasive, cost-effective screening tool. Despite ultrasound's accessibility, its diagnostic limitations necessitate further investigation to improve clinical outcomes.

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

90Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Group 1	Radiation	To determine the sensitivity of ultrasound in detecting HCC

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
ultrasound	Sensitivity and Specificity analysis of Ultrasound as diagnostic tool, with histopathology as gold standard.	12 Months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinically suspected liver cancer patients undergoing ultrasound examination.
Patients undergoing histopathological examination (liver biopsy or resection) for definitive diagnosis.

Exclusion Criteria:

- Patients with history of liver cancer treatment or inadequate data."

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

aim is to check the accuracy of Ultrasound's in Diagnosing Hepatocellular Carcinoma Using Histopathology as Gold Standard

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medcare International Hospital		Guiranwala	Punjab Province		Pakistan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006528	Carcinoma, Hepatocellular

Ancestor Terms

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided