The Jinling Cohort

August 23, 2023 updated by: Nanjing Shihejiyin Technology, Inc.

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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
Time Frame: assessed up to 60 months
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
Time Frame: 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
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 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
Time Frame: 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
assessed up to 60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing Shihejiyin Technology, Inc.

Investigators

  • Principal Investigator: Shao Yang, Ph.D, NanjingShihejiyin Technology Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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