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Trial record 1 of 1 for:    NCT06011694
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The Jinling Cohort

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ClinicalTrials.gov Identifier: NCT06011694
Recruitment Status : Recruiting
First Posted : August 25, 2023
Last Update Posted : August 25, 2023
Sponsor:
Information provided by (Responsible Party):
Nanjing Shihejiyin Technology, Inc.

Study Description
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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
Cancer Multi Cancer Early Screening Liquid Biopsy 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 Design
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Study Type : Observational
Estimated Enrollment : 15000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Multicenter Cohort Study of the Multi-omics Liquid Biopsy MCED Test MERCURY in an Average Risk Chinese Population
Actual Study Start Date : June 15, 2022
Estimated Primary Completion Date : May 15, 2027
Estimated Study Completion Date : May 15, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy Mercury

Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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:

  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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06011694


Contacts
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Contact: Shanshan Yang, Ph.D 8613585145836 admin@geneseeq.com
Contact: Xuan Wang 8618392411194 cohortstudy@geneseeq.com

Locations
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China, Jiangsu
Nanjing Jiangbei People's Hospital Recruiting
Nanjing, Jiangsu, China, 210000
Contact: Jianbei Huang    +8618951766697      
The Fourth Affiliated Hospital of Nanjing Medical University Recruiting
Nanjing, Jiangsu, China, 210000
Contact: Yuan Mao, Ph.D    +8613951918531      
Sponsors and Collaborators
Nanjing Shihejiyin Technology, Inc.
Investigators
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Principal Investigator: Shao Yang, Ph.D NanjingShihejiyin Technology Inc.
More Information
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Responsible Party: Nanjing Shihejiyin Technology, Inc.
ClinicalTrials.gov Identifier: NCT06011694    
Other Study ID Numbers: NanjingShihejiyinTech
First Posted: August 25, 2023    Key Record Dates
Last Update Posted: August 25, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nanjing Shihejiyin Technology, Inc.:
Early Detection of Cancer
MCED