NCT03064828

Brief Summary

This preliminary clinical trial aims to evaluate the performance of the low-dose CT colonoscopy (CTC) with computer aided detection (CAD) on polyps detection compared with optical colonoscopy (OC), and explore the possible clinical routine for integrated use of CT colonoscopy and optical colonoscopy OC in colorectal cancer screening.

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
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 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

January 1, 2017

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

January 24, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 27, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

July 20, 2018

Status Verified

November 1, 2017

Enrollment Period

1.9 years

First QC Date

January 24, 2017

Last Update Submit

July 18, 2018

Conditions

PolypsColorectal Neoplasm

Outcome Measures

Primary Outcomes (1)

  • Sensitivity and specificity of low-dose CTC for the polyp detection

    return the number of polyps detected by low-dose CTC for each participant, sensitivity and specificity of low-dose CTC for the polyp detection can be derive from it with OC results as reference.

    within the first 30 days (plus or minus 3 days) after the completion of the first part of the trial

Secondary Outcomes (3)

  • CT radiation

    within the first 3 days after each examination.

  • Sensitivity and specificity of CTC for the detection of polyps with different shapes

    within the first 30 days after the completion of the trial.

  • Sensitivity and specificity of CTC for the detection of poly malignancy

    within the first 30 days after the completion of the trial.

Study Arms (2)

CT colonoscopy(normal dose)

ACTIVE COMPARATOR

Perform CT colonoscopy with full bowel preparation and inflated colon, CT Scans on subjects with normal-dose protocol by setting scanning parameters as 120-140 kilovolts peak (kVp), 100-200mA

Radiation: CT colonoscopy(normal dose)

CT colonoscopy(low dose)

EXPERIMENTAL

Perform CT colonoscopy with full bowel preparation and inflated colon, CT Scans on subjects with normal-dose protocol by setting scanning parameters as 120-140 kVp, 20-100mA

Radiation: CT colonoscopy (low dose)

Interventions

CT colonoscopy(normal dose)RADIATION

Perform CT colonoscopy with full bowel preparation and inflated colon,CT Scans on subjects with normal-dose protocol by setting scanning parameters as 120-140 kVp, 100-200mA

CT colonoscopy(normal dose)
CT colonoscopy (low dose)RADIATION

Perform CT colonoscopy with full bowel preparation and inflated colon,CT Scans on subjects with normal-dose protocol by setting scanning parameters as 120-140 kVp, 20-100mA

CT colonoscopy(low dose)

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects with gastrointestinal symptoms potentially suggestive of colorectal cancer, such as diarrhea, constipation, abdominal pain or discomfort, rectal bleeding, iron-deficiency anemia, and unintended weight loss.
  • Subjects with pathological confirmed colorectal cancer or polyps that need follow-up examination.
  • Subjects with written consents

You may not qualify if:

  • Subjects with acute colitis
  • Acute diverticulitis
  • Inguinal hernia including colon
  • Colorectal surgery or endoscopic biopsy or resection of polyps within 6 months
  • Known or suspected as colon perforated
  • Complete intestinal obstruction
  • Pregnant or lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xi jing Hospital

Xi'an, Shaanxi, 710032, China

RECRUITING

MeSH Terms

Conditions

PolypsColorectal Neoplasms

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Shuhui Liang, MD

    Air Force Military Medical University, China

    STUDY DIRECTOR

  • Jiang Meng, MS

    Air Force Military Medical University, China

    PRINCIPAL INVESTIGATOR

  • Xiaofeng Zhang, MD

    Air Force Military Medical University, China

    PRINCIPAL INVESTIGATOR

  • Hong Yin, MD

    Air Force Military Medical University, China

    PRINCIPAL INVESTIGATOR

  • Hainan Sang, MS

    Air Force Military Medical University, China

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shuhui Liang, MD

CONTACT

liangsh@fmmu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2017

First Posted

February 27, 2017

Study Start

January 1, 2017

Primary Completion

December 1, 2018

Study Completion

December 1, 2019

Last Updated

July 20, 2018

Record last verified: 2017-11

Locations

CN(1)