Colorectal CancerNCT06347887
Clinical Validation of ColonAiQ (a Blood-based Assay Targeting ctDNA Methylation) for Colorectal Cancer Detection
An observational study of Colorectal Cancer, run by Singlera Genomics Inc. at 7 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- ColonAiQ test and Colonoscopy
- How many people
- 1,965 participants
- Where
- 7 sitesChina
- Study dates
- 31 May 2021to 16 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Age ≥18 years old, gender is not limited;
- 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:
- Confirmed non-CRC digestive tract cases: colorectal polyps, adenomas, and other benign diseases of the digestive system;
- Confirmed cases of other cancers other than CRC: gastric, esophageal, breast, and lung cancer;
- diseases where the same gene methylation may be present (non-rheumatoid arthritis, etc.);
- 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.
Who cannot join
- People who cannot tolerate relevant tests for clinical diagnosis;
- Pregnant women;
- Patients who have previously received colorectal cancer surgery, tumor drug therapy, neoadjuvant therapy, or radiotherapy;
- Other conditions deemed unsuitable for inclusion by the investigator.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites
Zhejiang provincial people's hospital
Hangzhou, Zhejiang, 310000
Cancer Hospital Affiliated to Shandong First Medical University (Shandong Institute of Cancer Prevention and Control, Shangdong Cancer Hospital)
Jinan, Shandong, 250000
Fudan University Shanghai Cancer Center
Shanghai, 200032
Shanxi Provincial People's Hospital
Taiyuan, Shanxi, 030012
Xi'an Daxing Hospital
Xi’an, Shanxi, 710000
Xi'an Gaoxin Hospital
Xi’an, Shanxi, 710000
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221000
About this study
Official title: 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.
Read the 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.
- Conditions
- Colorectal Cancer
- Being tested
- ColonAiQ test and Colonoscopy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColonAiQ test and ColonoscopyDiagnostic test
Diagnostic Test
| Study group | Role | What they receive |
|---|---|---|
| Colorectal cancer group | Patients who are 18 years of age and older and diagnosed with colorectal cancer. Receives: Diagnostic Test: ColonAiQ test and Colonoscopy | |
| 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. Receives: Diagnostic Test: ColonAiQ test and Colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity for colorectal cancer with ColonAiQ test
The proportion of participants with colorectal cancer who have positive test results
Measured: Up to 32 months
Specificity for colorectal cancer with ColonAiQ test
The proportion of negative test results among participants without CRC and other diseases
Measured: Up to 32 months
Secondary outcomes (2)
PPV for colorectal cancer with ColonAiQ test
Positive Predictive Value: the proportion of positive test participants who are colorectal cancer patients.
Measured: Up to 32 months
NPV for colorectal cancer with ColonAiQ test
Negative Predictive Value: the proportion of negative test participants who have no disease checked by colonoscopy.
Measured: Up to 32 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2024
- Study start31 May 2021
- Primary completion16 Jan 2024
- Study completion16 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,965 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singlera Genomics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Guoxiang Cai, M.D. Ph.D., Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06347887
- Sponsor's protocol ID
- SGI-PCR-01
- Status last verified
- Mar 2024
- First submitted
- 27 Mar 2024
- Last updated
- 3 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data that underlie the results reported in publications of the study may be shared after de-identification.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validation of ColonAiQ (a Blood-based Assay Targeting Circulating Tumor DNA Methylation) for Colorectal Cancer Detection
- ClinicalTrials.gov ID
- NCT06347887
- Acronym / sponsor ID
- SGI-PCR-01
- Conditions
- Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,965 participants (actual)
- Lead sponsor
- Singlera Genomics Inc.Industry (pharma, biotech, devices)
- Study start
- 31 May 2021 (actual)
- Primary completion
- 16 Jan 2024 (actual)
- Study completion
- 16 Jan 2024 (actual)
- First posted
- 4 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colorectal cancer group | – | Diagnostic Test: ColonAiQ test and ColonoscopyPatients who are 18 years of age and older and diagnosed with colorectal cancer. |
| Control group | – | Diagnostic Test: ColonAiQ test and ColonoscopyPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- Age ≥18 years old, gender is not limited;
- 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:
- 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.
Key exclusion criteria (4 listed)
- People who cannot tolerate relevant tests for clinical diagnosis;
- Pregnant women;
- Patients who have previously received colorectal cancer surgery, tumor drug therapy, neoadjuvant therapy, or radiotherapy;
- Other conditions deemed unsuitable for inclusion by the investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ColonAiQ test and ColonoscopyDiagnostic Test | Diagnostic test | Colorectal cancer group, Control group |
Primary outcome
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
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
2 secondary outcomes
PPV for colorectal cancer with ColonAiQ test
Time frame: Up to 32 months
NPV for colorectal cancer with ColonAiQ test
Time frame: Up to 32 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2024.
- Individual participant dataSharing planned: Undecided. Individual participant data that underlie the results reported in publications of the study may be shared after de-identification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guoxiang Cai, M.D. Ph.D. principal investigator
Fudan University
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by Singlera Genomics Inc. at 7 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity for colorectal cancer with ColonAiQ test (time frame: Up to 32 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2024.