NCT05440552

Brief Summary

A large-scale randomized controlled trial was conducted to compare different colorectal neoplasms screening strategies in China.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2022

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

First Submitted

Initial submission to the registry

June 23, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 1, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

July 1, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

July 1, 2022

Status Verified

June 1, 2022

Enrollment Period

1.2 years

First QC Date

June 23, 2022

Last Update Submit

June 29, 2022

Conditions

Colorectal Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Detection rate

    Detection of intestinal lesions

    up to 30 months

Study Arms (2)

Risk score1

PLACEBO COMPARATOR
Diagnostic Test: Qualitative Fecal immunochemical test + APCS score

Risk score2

ACTIVE COMPARATOR
Diagnostic Test: Quantitative Fecal immunochemical test

Interventions

Qualitative Fecal immunochemical test + APCS scoreDIAGNOSTIC_TEST

Risk stratification using Qualitative Fecal immunochemical test and APCS score

Risk score1
Quantitative Fecal immunochemical testDIAGNOSTIC_TEST

Use Quantitative Fecal immunochemical only for risk stratification

Risk score2

Eligibility Criteria

Age50 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old
  • Informed consent is available

You may not qualify if:

  • Previous colorectal cancer
  • Previous colorectal resection
  • Previous received cancer-related treatment (except non-melanoma skin cancer)
  • Colonoscopy, sigmoidoscopy, CT colonoscopy, and barium enema were performed within 5 years
  • Fecal occult blood or fecal DNA was performed within one year
  • Symptoms of lower digestive tract diseases requiring colonoscopy include: (1) rectal bleeding occurred more than once in the past 6 months, (2) recorded iron deficiency anemia, and (3) recorded significant weight loss within 6 months (\> 10% of baseline weight - Suffering from other diseases that affect the benefit of screening or intolerance to colonoscopy (for example, severe pulmonary disease, end-stage renal disease, end-stage liver disease, severe heart failure or recently diagnosed cancer, except non-melanoma skin cancer)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice President of Qilu Hospital

Study Record Dates

First Submitted

June 23, 2022

First Posted

July 1, 2022

Study Start

July 1, 2022

Primary Completion

September 1, 2023

Study Completion

December 1, 2023

Last Updated

July 1, 2022

Record last verified: 2022-06