detect five cancer types, which is lung cancer, colorectal cancer, liver cancer, grastic cancer and esophageal cancer
Conditions
Interventions
Gold Standard:Positive according to gold standard defines as "patient is clinically diagnosed with any one of the five types of cancer"
Index test:1.Feasibility of MCED in the intended use setting.
2.Safety of MCED in the intended use setting.
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
All
Age
40 Years to 74 Years
Inclusion criteria
Inclusion criteria: 1.40-74 years old; 2.Able to provide a written informed consent; 3.Willing to comply with all part of the protocol procedures.
Exclusion criteria
Exclusion criteria: 1.With cancer-associated clinical symptoms or suspected of cancer within 30 days prior to screen; 2.Have definite contraindications of cancer screening examination and diagnostic procedures; 3.Unable to comply with the protocol procedures; 4.Personal history of cancer, diagnosed within the 3 years prior to expected enrollment date; 5.Have received or are undergoing curative cancer treatment within three years prior to recruitment. Adjuvant endocrinotherapy for cancer is not an exclusion criterion; 6.Recipients of anti-tumor therapy within 30 days prior to screen; 7.Pregnancy or lactating women; 8.Recipients of organ transplant or prior bone marrow transplant or stem cell transplant; 9.Recipients of blood transfusion within 7 days prior to screen; 10.With autoimmune diseases; 11.Have an acute infection or inflammation or uncontrolled chronic infection within 14 days prior to blood draw; 12.Unsuitable for this trial determined by the researchers (eg. hemorrhagic diseases).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility of MCED in the intended use setting;Safety of MCED in the intended use setting; | — |
Secondary
| Measure | Time frame |
|---|---|
| Participant-reported psychological impact;Participant-reported health related quality of life (HRQoL);Cancer signal origin accuracy of MCED;Performance of MCED in the intended use setting;Clinical utility of MCED alongside SOC screening; | — |
Countries
China
Contacts
Public ContactXianjun Yu
Fudan University Shanghai Cancer Center
Outcome results
None listed