Evaluation of a Point-of-care Testing Instrument for Fecal Immunochemical Test

NCT05232721 | Unknown

• 1 other identifier: 2022SDU-QILU-105
• Study Type: observational
• Target: 275
• Locations: 1 country
• Sites: 1

Brief Summary

Early detecting and removing of colorectal advanced adenomas can reduce incidence of colorectal cancer.Use of the fecal immunochemical test (FIT) for colorectal cancer (CRC) prevention is supported by previous studies.However existing instruments have low portability.The purpose of this study is to test the performance of a Point-of-care testing instrument for fecal Immunochemical test(FIT) .

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Diagnostic performance of advanced neoplasms

  The study is committed to test the diagnostic efficacy of the new instrument to advanced neoplasms.We will measure the sensitivity and specificity of the instrument

  4 months

Secondary Outcomes (1)

• Diagnostic performance of Colorectal Cancer

  4 months

Study Arms (1)

Fecal Immunochemical Test

People in this group will detect hemoglobin in stool before colonoscopy by the new instrument

Diagnostic Test: The new instrument and colonoscopy with pathological examination

Interventions

The new instrument and colonoscopy with pathological examination DIAGNOSTIC_TEST

Detect hemoglobin in stool by the point-of-care testing instrument before colonoscopy, detect colon lesion using colonoscopy and pathological examination.

Fecal Immunochemical Test

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

People who use the new instrument for Fecal Immunochemical Test.

You may qualify if:

• People who use the new instrument for fecal immunochemical test(FIT)
• People sign an "informed consent form"

You may not qualify if:

• People with history of surgery in any part of the large bowel;
• People with symptoms including visible rectal bleeding, hematuria, hemorrhoid bleeds, severe and acute diarrhea and 7th type stool (Bristol feces score);

Sponsors & Collaborators

• Shandong University: lead

Study Sites (1)

Qilu Hospital

Jinan, Shandong, 250014, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

stool samples

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Colonoscopy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Li yanqing, Professor

  Qilu Hospital of Shandong University

  STUDY CHAIR

Central Study Contacts

Song yihao, BD

CONTACT

15098739370; 1019038804@qq.com

Zhou ruchen, MD

CONTACT

15949702165; sdlwzrc@126.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: January 6, 2022
• First Posted: February 10, 2022
• Study Start: February 20, 2022
• Primary Completion: April 1, 2022
• Study Completion: April 20, 2022
• Last Updated: February 10, 2022

Record last verified: 2022-02

Locations

CN (1)