The Jinling Cohort
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MERCURY test, health questionnaires and annual routine physical exams.
- Who it may be relevant to
- Registry conditions: Cancer, Multi Cancer Early Screening, Liquid Biopsy. Basic parameters: 45 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Prospective, Multicenter Cohort Study of the Multi-omics Liquid Biopsy MCED Test MERCURY in an Average Risk Chinese Population
Overview
The Jinling Cohort is a prospective, multicenter cohort study in which 15,000 eligible individuals aged 45-75 in Nanjing China will be enrolled.
Detailed 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.
Interventions
- Other MERCURY test, health questionnaires and annual routine physical exams
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.
Primary outcome measures
- To evaluate sensitivity, specificity, positive/negative predictive value and other performance measures of the multi-omics liquid biopsy test MERCURY for multi-cancer early detection in average risk population [Time frame: assessed up to 60 months]
Secondary outcome measures (3)
- To evaluate how many cancer types the multi-omics liquid biopsy MCED (multi-cancer early detection) test MERCURY can detect and TOO (tumor of origin) accuracy [Time frame: assessed up to 60 months]
- To assess test MERCURY's efficiency and clinical utility in average risk population [Time frame: assessed up to 60 months]
- To evaluate participants' attitude and perception towards MCED blood test [Time frame: assessed up to 60 months]
Eligibility criteria
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
- Pregnant women;
- Individuals who have history of cancer or current diagnosis of cancer;
- Individuals who have organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant;
- Individulas who have blood transfusion within 30 days prior to the blood draw;
- Individuals who have an acute infection or inflammation within 14 days prior to the blood draw;
- Individuals who have taken medication with anti-tumor effects within 30 days prior to the blood draw;
- Individuals who will not be able to comply with the protocol procedures judged by researchers
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
China · 2 centers
- Nanjing Jiangbei People's Hospital — Nanjing
- The Fourth Affiliated Hospital of Nanjing Medical University — Nanjing
Identifiers
NCT: NCT06011694 · NanjingShihejiyinTech