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NCT Number: NCT06011694

The Jinling Cohort

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

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Key information

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Nanjing Jiangbei People's Hospital, Nanjing, Jiangsu, China

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MERCURY test, health questionnaires and annual routine physical exams

Other

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 outcomes

  1. 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 outcomes

  1. 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

  2. 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.

  3. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Shanshan Yang, Ph.D

CONTACT

[email protected]

8613585145836

Xuan Wang

CONTACT

[email protected]

8618392411194

Sponsors and collaborators

Lead sponsor

Nanjing Shihejiyin Technology, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Aug 25, 2023
Registry last updated
Aug 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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