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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.
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

Full criteria on ClinicalTrials.gov

Sites (7)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Zhejiang Provincial People's Hospital
Coordinator of this site? Confirm its status
HangzhouChinaUnknown 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
JinanChinaUnknown status
Fudan University Shanghai Cancer Center
Coordinator of this site? Confirm its status
ShanghaiChinaUnknown status
Shanxi Provincial People's Hospital
Coordinator of this site? Confirm its status
TaiyuanChinaUnknown status
Xi'an Daxing Hospital
Coordinator of this site? Confirm its status
Xi’anChinaUnknown status
Xi'an Gaoxin Hospital
Coordinator of this site? Confirm its status
Xi’anChinaUnknown status
The affiliated hospital of xuzhou medical university
Coordinator of this site? Confirm its status
XuzhouChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.