The Jinling Cohort
Study Details
Study Description
Brief Summary
The Jinling Cohort is a prospective, multicenter cohort study in which 15,000 eligible individuals aged 45-75 in Nanjing China will be enrolled.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention 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. |
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.
|
Outcome Measures
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 [assessed up to 60 months]
Secondary Outcome Measures
- 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 [assessed up to 60 months]
To assess whether the TOO (tumor of origin) results predicted from the multi-omics liquid biopsy MCED (multi-cancer early detection) test MERCURY match with clinical diagnostic tumor types received from follow-up. Summarize the number of consistency and inconsistency to evaluate the prediction accuracy
- To assess test MERCURY's efficiency and clinical utility in average risk population [assessed up to 60 months]
To assess MERCURY test's lead-time relative to clinical diagnosis. 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 by comparing MERCURY test positive timepoint to tumor clinical diagnosis timepoint.
- To evaluate participants' attitude and perception towards MCED blood test [assessed up to 60 months]
To compare the adherence to annual blood exams to reported SOC (standard of care) screening methods to see whether participants' perception towards MCED blood test
Eligibility Criteria
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:
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Pregnant women;
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Individuals who have history of cancer or current diagnosis of cancer;
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Individuals who have organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant;
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Individulas who have blood transfusion within 30 days prior to the blood draw;
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Individuals who have an acute infection or inflammation within 14 days prior to the blood draw;
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Individuals who have taken medication with anti-tumor effects within 30 days prior to the blood draw;
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Individuals who will not be able to comply with the protocol procedures judged by researchers
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Nanjing Jiangbei People's Hospital | Nanjing | Jiangsu | China | 210000 |
| 2 | The Fourth Affiliated Hospital of Nanjing Medical University | Nanjing | Jiangsu | China | 210000 |
Sponsors and Collaborators
- Nanjing Shihejiyin Technology, Inc.
Investigators
- Principal Investigator: Shao Yang, Ph.D, NanjingShihejiyin Technology Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NanjingShihejiyinTech