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A Multicenter Clinical Trial of Stool-based DNA Testing for Early Detection of Colon Cancer in China

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ClinicalTrials.gov Identifier: NCT04722055
Recruitment Status : Recruiting
First Posted : January 25, 2021
Last Update Posted : June 10, 2021
Sponsor:
Information provided by (Responsible Party):
Creative Biosciences (Guangzhou) Co., Ltd.

Study Description
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Brief Summary:

According to data from Global Cancer Statistics 2018, colorectal cancer (CRC) ranks second in incidence and fifth in mortality among all cancers in China. The underlying neoplastic progression from adenoma to CRC endures up to 10 years, providing an extended window for CRC detection and screening. Currently, fecal occult blood test (FOBT) and colonoscopy are the main diagnostic and screening methods for CRC in Chinese clinical practice. However, due to low patients' compliance with colonoscopy and poor sensitivity of FOBT, a large proportion of CRC could not be effectively diagnosed and treated at early stage. Therefore, noninvasive fecal DNA detection approach with enhanced performance is urgently needed in clinic.

The aim of this trial is to evaluate effectiveness of the Human Multigene Methylation Detection Kit (Fluorescent PCR) for auxiliary diagnosis of colorectal cancer. By assessing the level of DNA methylation of certain genes in human stool, the test can indicate whether cancerous and precancerous lesions exist in the areas of colon and rectum.


Condition or disease Intervention/treatment
Colorectal Cancer Advanced Adenocarcinoma Hyperplastic Polyp Colorectal Neoplasms Digestive System Neoplasm Neoplasms Diagnostic Test: Multigene Methylation Detection Kit

Detailed Description:
The multicenter clinical trial will be conducted using a single-blind method. Stool samples provided by participants will be evaluated by Human Multigene Methylation Detection Kit (Fluorescent PCR). The kit will be used to qualitatively detect methylation levels of multiple genes in human stool samples in vitro by using Quantitative Methylation Specific PCR (qMSP). The principle of the method is as follows. First, the target DNA in human stool is extracted by magnetic bead-capture technology and then treated with sodium bisulfite. The sequence of unmethylated DNA will be changed while that of the methylated DNA remains the same after sodium bisulfite treatment. Subsequently, qMSP is employed to detect methylation levels of target genes in addition to ACTB gene (a reference gene). Controls of ACTB gene with and without methylation are tested simultaneously. Result of qMSP is dichotomized as positive and negative based on Ct value obtained. The test result is then verified by Sanger sequencing and compared with that from colonoscopy examination and pathology report. The main evaluation indexes for test performance are sensitivity, specificity, consistency rate, kappa coefficient.
Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1113 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Months
Official Title: A Multicenter Clinical Trial of Human Multigene Methylation Detection Kit (Fluorescent PCR)
Actual Study Start Date : January 26, 2021
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Groups and Cohorts
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Group/Cohort Intervention/treatment
Study group
Single arm of continuously enrolled participants. All eligible participants will be included in the study according to the inclusion criteria. In addition to giving stool samples for multigene methylation test, eligible participants need to undergo colonoscopy examination and have their biopsies taken when necessary (gold standard).
 Diagnostic Test: Multigene Methylation Detection Kit
Eligible participants are required to take stool samples for multigene methylation detection and gene sequencing, undergo colonoscopy examination, and have a biopsy when necessary (gold standard).
Other Name: Colosafe 2.0


Outcome Measures
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Primary Outcome Measures :
  1. Sensitivity [ Time Frame: Two years ]
    Sensitivity is the true positive fraction of participants with colorectal cancer.

  2. Specificity [ Time Frame: Two years ]
    Specificity is the true negative fraction of participants without colorectal cancer.

  3. Consistency rate [ Time Frame: Two years ]
    Consistency rate is the fraction of both true positive and negative diagnostic test results among all participants.

  4. Kappa coefficient [ Time Frame: Two years ]
    Kappa coefficient is the consistency analysis of the extent of agreement between the test results of Colosafe 2.0 and reference colonoscopy.


Biospecimen Retention:   Samples With DNA
Isolated human DNA from stool samples

Eligibility Criteria
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Ages Eligible for Study:   40 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Participants aged 40-79 years old, regardless of gender or region, and those who meet the inclusion criteria for this clinical trial, are eligible to enroll at the designated clinical sites. Up to 1113 participants will be enrolled.
Criteria

Inclusion Criteria:

  • Participants must also meet the following three criteria to be included in this study:

    1. To be 40 to 79 years old, regardless of gender;
    2. To participate voluntarily and sign Informed Consent Form;

    3. To satisfy any of the following three conditions:

      1. Patients with colorectal cancer confirmed or suspected by colonoscopy or pathological biopsy;
      2. Patients with gastrointestinal disease or normal population to be examined by colonoscopy;
      3. Patients who are planning to undergo colonoscopy or have colonoscopy results from other interfering diseases.

Exclusion Criteria:

  • Patients with any of the following conditions shall be excluded:

    1. To have had radical resection of colorectal cancer before enrollment in this study;
    2. To have been deemed ineligible to participate in the study by the principal investigator due to various other reasons.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04722055


Contacts
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Contact: Chunhua Chan +86 13560141654 chenchunhua@creativebio.cn
Contact: Xianshu Wang, PhD +86 18819269978 xianshuwang@creativebio.cn

Locations
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China, Shandong
Shandong Cancer Hospital and Institute Recruiting
Jinan, Shandong, China
Contact: Xianrang Song, PhD    +86-0531-67626289    sxr@vip.163.com   
Sponsors and Collaborators
Creative Biosciences (Guangzhou) Co., Ltd.
Investigators
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Principal Investigator: Xianrang Song, PhD Shandong Cancer Hospital and Institute
More Information
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Responsible Party: Creative Biosciences (Guangzhou) Co., Ltd.
ClinicalTrials.gov Identifier: NCT04722055    
Other Study ID Numbers: KLM2020-02
First Posted: January 25, 2021    Key Record Dates
Last Update Posted: June 10, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We are carefully considering all applicable regulations and laws governing sharing of patients' data from China online with the global public.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Creative Biosciences (Guangzhou) Co., Ltd.:
Colorectal Cancer
Colon Cancer
Stool DNA test
fecal DNA test
 Methylation Biomarkers
Colonoscopy
Cancer Screening
Additional relevant MeSH terms:
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Neoplasms
Colorectal Neoplasms
Digestive System Neoplasms
Gastrointestinal Neoplasms
Intestinal Neoplasms
Neoplasms by Site
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases