NCT06347887Completed
Clinical Validation of ColonAiQ (a Blood-based Assay Targeting ctDNA Methylation) for Colorectal Cancer Detection
Clinical Validation of ColonAiQ (a Blood-based Assay Targeting Circulating Tumor DNA Methylation) for Colorectal Cancer Detection
Source: ClinicalTrials.gov · Last updated 3 Jun 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 1965 (actual)
- First submitted
- 27 Mar 2024
- Start date
- May 2021
- Primary completion date
- Jan 2024
- Lead sponsor
- Singlera Genomics Inc.
- Diseases
- Colorectal cancer
- NCT number
- NCT06347887
What you commit to
- Study type: Observational
- Participants enrolled: 1965
- From May 2021 to the primary completion date, Jan 2024
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who have previously received colorectal cancer surgery, tumor drug therapy, neoadjuvant therapy, or radiotherapy;
Other illness
- Other conditions deemed unsuitable for inclusion by the investigator.
Other
- People who cannot tolerate relevant tests for clinical diagnosis;
- Pregnant women;
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Zhejiang Provincial People's Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Cancer Hospital Affiliated to Shandong First Medical University (Shandong Institute of Cancer Prevention and Control, Shangdong Cancer Hospital) Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| Fudan University Shanghai Cancer Center Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Shanxi Provincial People's Hospital Coordinator of this site? Confirm its status | Taiyuan | China | Unknown status |
| Xi'an Daxing Hospital Coordinator of this site? Confirm its status | Xi’an | China | Unknown status |
| Xi'an Gaoxin Hospital Coordinator of this site? Confirm its status | Xi’an | China | Unknown status |
| The affiliated hospital of xuzhou medical university Coordinator of this site? Confirm its status | Xuzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.