NCT03750617

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 27, 2018

Completed
8 months until next milestone

First Posted

Study publicly available on registry

November 23, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

November 23, 2018

Status Verified

November 1, 2018

Enrollment Period

2 years

First QC Date

March 27, 2018

Last Update Submit

November 20, 2018

Conditions

Colorectal Polyp

Keywords

Colorectal PolypScreeningRisk assessment

Outcome Measures

Primary Outcomes (1)

  • Diagnostic rate of patients with polyps

    Diagnostic rate of patients with polyps

    2 year

Secondary Outcomes (1)

  • Number and characteristics of polyps detected

    2 year

Study Arms (2)

pre-endoscopic screening risk assessment

EXPERIMENTAL
Diagnostic Test: pre-endoscopic screening risk assessment

routine screening

NO INTERVENTION

Interventions

pre-endoscopic screening risk assessmentDIAGNOSTIC_TEST

pre-endoscopic screening risk assessment

pre-endoscopic screening risk assessment

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-65.
  • Signed informed consent

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

State Key laboratory of Cancer Biology

Xi'an, Shaanxi, 710032, China

RECRUITING

Central Study Contacts

Dake Chu, M.D.

CONTACT

86-29-85323922chudake@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 27, 2018

First Posted

November 23, 2018

Study Start

December 1, 2017

Primary Completion

December 1, 2019

Study Completion

December 1, 2020

Last Updated

November 23, 2018

Record last verified: 2018-11

Locations

CN(1)