Exploring the Risk Factors for Colorectal Cancer in Our G... | NCT05617378

Studies
Exploring the Risk Factors for Colorectal Cancer in Our General Population Using Asian Pacific Screening Score: a Survey From Pakistan

NCT05617378

Sponsor

Sindh Institute of Urology and Transplantation

Status

Completed

Last Update Posted

Apr 22, 2024Actual

Enrollment

558Actual

Phase

Not provided

Conditions

Colorectal Cancer
Colorectal Neoplasms

Interventions

Not provided

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

Apr 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

Nov 1, 2022Actual

Primary Completion Date

Oct 31, 2023Actual

Completion Date

Dec 31, 2023Actual

First Submitted Date

Nov 7, 2022

First Submission Date that Met QC Criteria

Nov 7, 2022

First Posted Date

Nov 15, 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

Apr 19, 2024

Last Update Posted Date

Apr 22, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Murk Niaz, Medical Officer, Sindh Institute of Urology and TransplantationPrincipal Investigator

Lead Sponsor

Sindh Institute of Urology and TransplantationOTHER

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

In Pakistan, due to the lack of a National based cancer registry exact number of CRC cases is unknown. However, minimal data that is present in literature shows an increase in CRC cases with a concerning increase in incidence in younger age groups11. This makes it pertinent to understand current pattern of CRC and its risk factors from a local perspective. This will direct future strategies in an attempt to reduce the incidence and mortality associated with CRC in our general population.

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

558Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Risk factor	evaluate internationally validated risk factors for colorectal cancer in our general population using a questionnaire based on the modified Asian Pacific Colorectal Screening score.	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Individuals visiting SIUT as attendants to the patients visiting outpatient department or admitted in hospital.

Exclusion Criteria:

Attendants / whose patients visit GI, colon and oncology OPD outpatient department or admitted in GI wards.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

attendants to the patients visiting outpatient department or admitted in hospital.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Muhammad Shadab Khan	Sindh Institute of Urology and Transplantation	Principal Investigator
Bushra Shirazi	Sindh Institute of Urology and Transplantation	Study Chair
Muhammad Arsalan Khan	Sindh Institute of Urology and Transplantation	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sindh Institute of Urology and Transplantation		Karachi	Sindh		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
D015179	Colorectal Neoplasms

Ancestor Terms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided