The Jinling Cohort

A Prospective, Multicenter Cohort Study of the Multi-omics Liquid Biopsy MCED Test MERCURY in an Average Risk Chinese Population

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

Study Overview

• Status: Recruiting
• Conditions: Cancer; Liquid Biopsy; Multi Cancer Early Screening
• Intervention / Treatment: Other: MERCURY test, health questionnaires and annual routine physical exams

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 Type: Observational
• Enrollment (Estimated): 15000

Contacts and Locations

• Study Contact: Name: Shanshan Yang, Ph.D; Phone Number: 8613585145836; Email: admin@geneseeq.com
• Study Contact Backup: Name: Xuan Wang; Phone Number: 8618392411194; Email: cohortstudy@geneseeq.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210000
      • Recruiting
      • Nanjing Jiangbei People's Hospital
      • Contact: Jianbei Huang; Phone Number: +8618951766697
    • Nanjing, Jiangsu, China, 210000
      • Recruiting
      • The Fourth Affiliated Hospital of Nanjing Medical University
      • Contact: Yuan Mao, Ph.D; Phone Number: +8613951918531

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

45 Years to 75 Years (Adult, Older Adult)，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.

No

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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	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	assessed up to 60 months
To assess test MERCURY's efficiency and clinical utility in average risk population	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.	assessed up to 60 months
To evaluate participants' attitude and perception towards MCED blood test	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	assessed up to 60 months

Collaborators and Investigators

• Sponsor: Nanjing Shihejiyin Technology, Inc.
• Investigators: Principal Investigator: Shao Yang, Ph.D, NanjingShihejiyin Technology Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2022
• Primary Completion (Estimated): May 15, 2027
• Study Completion (Estimated): May 15, 2027

Study Registration Dates

• First Submitted: August 9, 2023
• First Submitted That Met QC Criteria: August 23, 2023
• First Posted (Actual): August 25, 2023

Study Record Updates

• Last Update Posted (Actual): August 25, 2023
• Last Update Submitted That Met QC Criteria: August 23, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Early Detection of Cancer; MCED
• Other Study ID Numbers: NanjingShihejiyinTech

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No