The Jinling Cohort

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06011694
• Other study ID #: NanjingShihejiyinTech
• Status: Recruiting
• Start date: June 15, 2022
• Est. completion date: May 15, 2027

Study information

• Verified date: August 2023
• Source: Nanjing Shihejiyin Technology, Inc.
• Contact: Shanshan Yang, Ph.D
• Phone: 8613585145836
• Email: admin[@]geneseeq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15000
• Est. completion date: May 15, 2027
• Est. primary completion date: May 15, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Liquid Biopsy

Intervention

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.

Locations

Country	Name	City	State
China	Nanjing Jiangbei People's Hospital	Nanjing	Jiangsu
China	The Fourth Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing Shihejiyin Technology, Inc.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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