NCT06785714

Brief Summary

The primary objective of this study is to evaluate the sensitivity of the fecal protein dual-index test reagent for the detection of colorectal cancer (CRC).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

September 1, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2025

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 21, 2025

Completed
Last Updated

January 21, 2025

Status Verified

January 1, 2025

Enrollment Period

5 months

First QC Date

January 15, 2025

Last Update Submit

January 15, 2025

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (2)

  • Sensitivity of colorectal cancer detection

    Sensitivity of colorectal cancer detection

    180 days

  • Specificity of advanced neoplasia detection

    Specificity of advanced neoplasia detection

    180 days

Secondary Outcomes (3)

  • Positive predictive value of colorectal cancer detection

    180 days

  • Negative predictive value of colorectal cancer detection

    180 days

  • Sensitivity and specificity of advanced adenoma detection

    180 days

Eligibility Criteria

Age45 Years - 74 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Single cohort of patients aged between 45 and 84, with no known high risk features, undergoing routine colorectal cancer screening as standard of care.

You may qualify if:

  • Subjects aged 45-74 years at time of consent
  • Have not had gastrointestinal resection

You may not qualify if:

  • Previous history of colorectal cancer
  • Patients who have been confirmed to have other malignant neoplastic diseases of the digestive system
  • Patients with severe heart, brain, lung disease or liver and kidney dysfunction or insufficiency
  • Those with severe mental disorders and language communication disorders
  • History of contraindications to colonoscopy
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Xinxiang Medical University

Xinxiang, Henan, 453100, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Residual stool samples will be used to develop and evaluate the performance of biomarker assays to detect cancers and advanced precancerous lesions. Samples may be stored for up to 20 years. These stool samples will be deidentified.

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
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2025

First Posted

January 21, 2025

Study Start

September 1, 2024

Primary Completion

January 15, 2025

Study Completion

January 15, 2025

Last Updated

January 21, 2025

Record last verified: 2025-01

Locations

CN(1)