Effectiveness of Multi-target FIT-DNA Analysis as a Colorectal Cancer Screening Test

December 8, 2019 updated by: Dr. Dominic C.C. Foo, The University of Hong Kong

Colorectal cancer is one of the most common cancer in Hong Kong. In 2018, CRC accounted for 17.4%, 5,780 cases, of the total new cancers. CRC claimed 2,279 lives (15.8%) making it the second most deadly killer in the population.

Since 2010, the Cancer Expert Working Group (CEWG) has recommended that asymptomatic average-risk individuals aged 50 to 75 years should consider one of the screening methods: fecal occult blood test (FOBT) every one to two years; OR flexible sigmoidoscopy every 5 years; OR colonoscopy every 10 years. However, it poses great challenges for large scale CRC screening using colonoscopy, such as bowel preparation difficulties, complications of procedure and poor compliance.

ColoClear® is intended for use as an adjunctive screening test for the detection of colorectal neoplasia associated DNA markers and for the presence of occult hemoglobin in human stool. It has the potential of increasing the sensitivity of detecting CRC as compared to FOBT or faecal immunochemical test (FIT), which detects the presence of hemoglobin in stool alone. A positive result may indicate the presence of colorectal cancer or pre-malignant colorectal neoplasia. ColoClear® is not intended as a replacement for diagnostic colonoscopy. A positive result in ColoClear®, as with any screening test, should be followed by colonoscopy. ColoClear® is intended for colorectal cancer screening in average risk individuals: adults of either sex, 40 years or older, who are at high risk for colorectal cancer.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The objective of this study is to evaluate the clinical performance of ColoClear test in early screening of colorectal cancer in Hong Kong. Other outcomes to analyze include, but are not limited to the point estimate of the sensitivity of ColoClear for the detection of advanced adenoma (AA) in Hong Kong.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Dominic CC Foo, MBBS
  • Phone Number: 85222554389
  • Email: ccfoo@hku.hk

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

300 subjects (assume 20% drop out rate)

Description

Inclusion Criteria:

  • Subject is at average risk for development of CRC.
  • Subject is male or female (all Asian), 40-74 years of age.
  • Subject is able to comprehend, sign and date the written informed consent form to participate in this study, undergo study procedures described in the informed consent form and authorizes release of relevant protected health information through signing an informed consent form.

Exclusion Criteria:

  • Subject undergone colonoscopy and removal of lesions within 5 years.
  • Subject with Familial Adenomatous Polyposis (FAP) and Inflammatory Bowel Disease (IBD) including chronic ulcerative colitis (CUC) and Crohn's disease.
  • Subject with overt rectal bleeding, e.g., hematochezia or melena, within the previous 30 days.
  • Any condition which, in the opinion of the investigator should preclude participation in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Cancer
Case subjects (at least 50) will be men and women age 40-74 who are recently diagnosed, through colonoscopy, with different stages of colorectal cancer and have not yet had surgical intervention.
Diagnostic test: multi-target FIT-DNA analysis
ColoClear® is intended for use as an adjunctive screening test for the detection of colorectal neoplasia associated DNA markers and for the presence of occult hemoglobin in human stool. It has the potential of increasing the sensitivity of detecting CRC as compared to FOBT or faecal immunochemical test (FIT), which detects the presence of hemoglobin in stool alone. A positive result may indicate the presence of colorectal cancer or pre-malignant colorectal neoplasia. ColoClear® is not intended as a replacement for diagnostic colonoscopy. A positive result in ColoClear®, as with any screening test, should be followed by colonoscopy. ColoClear® is intended for colorectal cancer screening in average risk individuals: adults of either sex, 40 years or older, who are at high risk for colorectal cancer.
Other Names:
  • Coloclear
Negative
Approximately 250 prospectively enrolled subjects will be men and women age 40-74 who are at average risk of developing colorectal cancer and eligible for colonoscopy. About 150 Control subjects will be enrolled prospectively, who have no colorectal neoplasia detected on colonoscopy, including cancer, advanced adenoma, sessile serrated lesions and small, non-advanced adenoma.
Diagnostic test: multi-target FIT-DNA analysis
ColoClear® is intended for use as an adjunctive screening test for the detection of colorectal neoplasia associated DNA markers and for the presence of occult hemoglobin in human stool. It has the potential of increasing the sensitivity of detecting CRC as compared to FOBT or faecal immunochemical test (FIT), which detects the presence of hemoglobin in stool alone. A positive result may indicate the presence of colorectal cancer or pre-malignant colorectal neoplasia. ColoClear® is not intended as a replacement for diagnostic colonoscopy. A positive result in ColoClear®, as with any screening test, should be followed by colonoscopy. ColoClear® is intended for colorectal cancer screening in average risk individuals: adults of either sex, 40 years or older, who are at high risk for colorectal cancer.
Other Names:
  • Coloclear

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Sensitivity & specificity of colorectal cancer detection
Time Frame: within 3 months
The primary endpoint is the point estimate of sensitivity and specificity of ColoClear for screening of CRC.
within 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Hong Kong

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dominic CC Foo, MBBS, The University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 8, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 8, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 11, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 11, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 8, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UW 19-784

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

The data could be stored in a public repository for other researchers after completion

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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