The Jinling Cohort

Nanjing Shihejiyin Technology

Status: Enrolling

Conditions: Multi Cancer Early Screening; Cancer; Liquid Biopsy

Treatments: Other: MERCURY test, health questionnaires and annual routine physical exams

Study type: Observational

Funder types: Industry

Identifiers

NCT06011694

NanjingShihejiyinTech

Details and patient eligibility

About

The Jinling Cohort is a prospective, multicenter cohort study in which 15,000 eligible individuals aged 45-75 in Nanjing China will be enrolled.

Full description

Its aim is to assess the performance and clinical utility of the Multi-omics liquid biopsy MCED test MERCURY in an average risk Chinese population. Each participant will undergo peripheral blood collection for MERCURY test, health questionnaires and annual routine physical exams once a year for three consecutive years, then followed up two additional years. The entire assess time is 60 months.

The primary goals of the study is to evaluate sensitivity, specificity, positive/negative predictive value and other performance of MERCURY test.

The secondary goal of the study is (1) to evaluate how many cancer types the test MERCURY can detect and TOO accuracy; (2) With MCED test and routine physical exams being conducted in parallel for three years and following up for five years, the study allows to assess MERCURY test can detect cancer how many years earlier than conventional methods, leading to its clinical value evaluation of whether it can ensure reduction in late-stage cancer diagnosis; (3) to evaluate participants' attitude and perception towards MCED blood test.

Enrollment: 15,000 estimated patients

Sex: All

Ages: 45 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1、45-75 years of age; 2、Willing and able to undergo blood sample collection, health questionnaires and annual routine physical exams once a year for three consecutive years; 3、Residents in Nanjing; 4、Fully understand the study and able to provide a written informed consent

Exclusion criteria

1. Pregnant women;
2. Individuals who have history of cancer or current diagnosis of cancer;
3. Individuals who have organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant;
4. Individulas who have blood transfusion within 30 days prior to the blood draw;
5. Individuals who have an acute infection or inflammation within 14 days prior to the blood draw;
6. Individuals who have taken medication with anti-tumor effects within 30 days prior to the blood draw;
7. Individuals who will not be able to comply with the protocol procedures judged by researchers

Trial design

15,000 participants in 1 patient group

No Intervention

Description:

Each participant will undergo peripheral blood collection for MERCURY test, health questionnaires and annual routine physical exams once a year for three consecutive years, then followed up two additional years.

Treatment:

Other: MERCURY test, health questionnaires and annual routine physical exams