Web-Mediated Risk Assessment for Endoscopic Screening of... | NCT03750617

Studies
Web-Mediated Risk Assessment for Endoscopic Screening of Colorectal Polyps

NCT03750617

Sponsor

State Key Laboratory of Cancer Biology

Status

Unknown status

Last Update Posted

Nov 23, 2018Actual

Enrollment

1,000Estimated

Phase

Not Applicable

Conditions

Colorectal Polyp

Interventions

pre-endoscopic screening risk assessment

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

Nov 2018

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

Dec 1, 2017Actual

Primary Completion Date

Dec 1, 2019Estimated

Completion Date

Dec 1, 2020Estimated

First Submitted Date

Mar 27, 2018

First Submission Date that Met QC Criteria

Nov 20, 2018

First Posted Date

Nov 23, 2018Actual

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

Nov 20, 2018

Last Update Posted Date

Nov 23, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dake Chu, Principal Investigator, State Key Laboratory of Cancer BiologyPrincipal Investigator

Lead Sponsor

State Key Laboratory of Cancer BiologyNETWORK

Collaborators

Name	Class
Xijing Hospital	OTHER
Tang-Du Hospital	OTHER

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

Colorectal polyps are risk factors for cancer. Early detection of polyps is critical for colorectal cancer management. However, the diagnosis rate of patients with colorectal polyps is still low. Therefore, we design this study to access whether pre-endoscopic screening risk assessment of genetic and environmental risk factors could improve diagnosis rate of colorectal polyps.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
pre-endoscopic screening risk assessment	Experimental		Diagnostic Test: pre-endoscopic screening risk assessment
routine screening	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
pre-endoscopic screening risk assessment	Diagnostic Test	pre-endoscopic screening risk assessment	pre-endoscopic screening risk assessment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Diagnostic rate of patients with polyps	Diagnostic rate of patients with polyps	2 year

Secondary Outcomes

Measure	Description	Time Frame
Number and characteristics of polyps detected	Characterization of types of polyps	2 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18-65.
Signed informed consent

Exclusion Criteria:

Severe back ground disease including malignancy.
State after gastric surgery.
COPD, CHF, CRF and any disease with respiratory disturbances.
Deviation of the nasal septum, lack of venous access at the dorsum of the hand or any other technical problem prevents gastric acid collection or base excess evaluation.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Dake Chu, M.D.	Contact	86-29-85323922		chudake@hotmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
State Key laboratory of Cancer Biology	Recruiting	Xi'an	Shaanxi	710032	China