Pathological Characteristics of Basal Cell Carcinoma | NCT05267691

Studies
Pathological Characteristics of Basal Cell Carcinoma

NCT05267691

Sponsor

Al-Azhar University

Status

Unknown status

Last Update Posted

Jul 20, 2022Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Dermatological Tumors

Interventions

Excision

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

Jul 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2017Actual

Primary Completion Date

Mar 20, 2022Actual

Completion Date

Oct 20, 2022Estimated

First Submitted Date

Feb 24, 2022

First Submission Date that Met QC Criteria

Feb 24, 2022

First Posted Date

Mar 4, 2022Actual

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

Jul 18, 2022

Last Update Posted Date

Jul 20, 2022Actual

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

A hospital based cross-sectional study was conducted from 2017 to February 2021. Clinical history, examination and histopathological variants were collected from medical files and pathology reports. Confirmation of pathology was done in all the patients visiting skin and plastic surgery department with suspected lesions.

Detailed Description

Some cases may be tested for immunohistochemistry on the tissue block

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

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
sun-protected		All patients with basal cell carcinoma in a sun protected body site	Procedure: Excision
sun-exposed		All patients with basal cell carcinoma in a sun exposed body site	Procedure: Excision

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Excision	Procedure	Surgical excision of the lesion and histopathology evaluation using Hematoxylin and Eosin stains	sun-exposed sun-protected

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Healing	Complete removal of the lesion	1 day

Secondary Outcomes

Measure	Description	Time Frame
Recurrence	Occurrence of recurrence	1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Excised lesion
Confirmed basal cell carcinoma pathologically

Exclusion Criteria:

Incision biopsy
Incomplete follow up

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

100 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Visiting dermatology or surgery clinics in the tertiary hospital

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Abdulkarim Hasan, MD	Contact			doctorabdulkarim7@gmail.com

Overall Officials

Name	Affiliation	Role
Abdulkarim Hasan	Al-Azhar University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Abdulkarim Hasan	Recruiting	Cairo		11884	Egypt

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
D012878	Skin Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

Browse Leaves

Not provided

Browse Branches

Not provided