Clinical Validation of ColonAiQ (a Blood-based Assay Targeting ctDNA Methylation) for Colorectal Cancer Detection

May 31, 2024 updated by: Singlera Genomics Inc.

Clinical Validation of ColonAiQ (a Blood-based Assay Targeting Circulating Tumor DNA Methylation) for Colorectal Cancer Detection

The DNA methylation targets in preoperative plasma samples of the subjects will be detected by the multi-gene methylation test (ColonAiQ), and the test accuracy will be evaluated by compared with the clinical diagnosis evidence.

Study Overview

Status

Status

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

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 accuracy of ColonAiQ test in clinical testing will be evaluated in the multicenter, prospective study. Patients with colorectal cancer, intestinal polyps, adenomas and other non-neoplastic diseases of the digestive system, and patients with non-colorectal cancer such as gastric cancer, esophageal cancer, breast cancer and lung cancer will be enrolled. In this study, all cfDNA will be tested by fluorescence quantitative PCR, and some samples will be tested by NGS to verify the effectiveness of ColonAiQ test. Clinical diagnosis reports and methylation test results will be blinded to the lab tester and clinician respectively.

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 (Actual)

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.
1965

Contacts and Locations

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

Study Locations

  • China
      • Shanghai, China, 200032
        • Fudan University Shanghai Cancer Center
    • Jiangsu
      • Xuzhou, Jiangsu, China, 221000
        • The Affiliated Hospital of Xuzhou Medical University
    • Shandong
      • Jinan, Shandong, China, 250000
        • Cancer Hospital Affiliated to Shandong First Medical University (Shandong Institute of Cancer Prevention and Control, Shangdong Cancer Hospital)
    • Shanxi
      • Taiyuan, Shanxi, China, 030012
        • Shanxi Provincial People's Hospital
      • Xi'an, Shanxi, China, 710000
        • Xi'an Daxing Hospital
      • Xi'an, Shanxi, China, 710000
        • Xi'an Gaoxin Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Zhejiang Provincial People's Hospital

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Subjects 18 years of age and older who are eligible for colorectal cancer diagnosis and scheduled for a screening colonoscopy. more than 1000 subjects are targeted to enroll.

Description

Inclusion Criteria:

  1. Age ≥18 years old, gender is not limited;

  2. meet one of the following conditions: 1) Suspected colorectal cancer (CRC); 2) Diagnosed with CRC according to clinical diagnostic criteria; 3) Do not have CRC and have interfering diseases:

    1. Confirmed non-CRC digestive tract cases: colorectal polyps, adenomas, and other benign diseases of the digestive system;
    2. Confirmed cases of other cancers other than CRC: gastric, esophageal, breast, and lung cancer;
    3. diseases where the same gene methylation may be present (non-rheumatoid arthritis, etc.);
  3. The subject or his/her guardian is able to understand the purpose of the study, demonstrate sufficient adherence to the study protocol, and sign the informed consent.

Exclusion Criteria:

  1. People who cannot tolerate relevant tests for clinical diagnosis;
  2. Pregnant women;
  3. Patients who have previously received colorectal cancer surgery, tumor drug therapy, neoadjuvant therapy, or radiotherapy;
  4. Other conditions deemed unsuitable for inclusion by the investigator.

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

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.
Colorectal cancer group
Patients who are 18 years of age and older and diagnosed with colorectal cancer.
Diagnostic test: ColonAiQ test and Colonoscopy
Diagnostic Test
Control group
Patients with other non-neoplastic diseases of the digestive system, and patients with non-colorectal cancer such as gastric cancer, esophageal cancer, breast cancer and lung cancer, etc. as well as Individuals without any diseases checked by colonoscopy.
Diagnostic test: ColonAiQ test and Colonoscopy
Diagnostic Test

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 for colorectal cancer with ColonAiQ test
Time Frame: Up to 32 months
The proportion of participants with colorectal cancer who have positive test results
Up to 32 months
Specificity for colorectal cancer with ColonAiQ test
Time Frame: Up to 32 months
The proportion of negative test results among participants without CRC and other diseases
Up to 32 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
PPV for colorectal cancer with ColonAiQ test
Time Frame: Up to 32 months
Positive Predictive Value: the proportion of positive test participants who are colorectal cancer patients.
Up to 32 months
NPV for colorectal cancer with ColonAiQ test
Time Frame: Up to 32 months
Negative Predictive Value: the proportion of negative test participants who have no disease checked by colonoscopy.
Up to 32 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.
Singlera Genomics Inc.

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: Guoxiang Cai, M.D. Ph.D., Fudan University

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 (Actual)

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.
May 31, 2021

Primary Completion (Actual)

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.
January 16, 2024

Study Completion (Actual)

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.
January 16, 2024

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).
March 27, 2024

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.
April 2, 2024

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.
April 4, 2024

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.
June 3, 2024

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.
May 31, 2024

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.
March 1, 2024

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.
  • SGI-PCR-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Individual participant data that underlie the results reported in publications of the study may be shared after de-identification.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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