Clinical trial NCT06011694: The Jinling Cohort
Official title: A Prospective, Multicenter Cohort Study of the Multi-omics Liquid Biopsy MCED Test MERCURY in an Average Risk Chinese Population
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
Multi Cancer Early Screening
Liquid Biopsy
Keywords: Early Detection of Cancer
MCED
Lead sponsor: Nanjing Shihejiyin Technology, Inc.
Sponsor class: INDUSTRY
First posted: 2023-08-25
Enrollment: 15000
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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.

Eligibility 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

Primary outcomes:
measure: 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
timeFrame: assessed up to 60 months
Secondary outcomes:
measure: 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
timeFrame: assessed up to 60 months
measure: To assess test MERCURY's efficiency and clinical utility in average risk population
timeFrame: assessed up to 60 months
measure: To evaluate participants' attitude and perception towards MCED blood test
timeFrame: assessed up to 60 months
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Jiangbei People's Hospital
state: Jiangsu
city: Nanjing
country: China
facility: The Fourth Affiliated Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: NanjingShihejiyin Technology Inc.
name: Shao Yang, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: