NCT06011694

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15,000

participants targeted

Target at P75+ for all trials

Timeline
13mo left

Started Jun 2022

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress79%
Jun 2022May 2027

Study Start

First participant enrolled

June 15, 2022

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 9, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 25, 2023

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2027

Last Updated

August 25, 2023

Status Verified

August 1, 2023

Enrollment Period

4.9 years

First QC Date

August 9, 2023

Last Update Submit

August 23, 2023

Conditions

CancerMulti Cancer Early ScreeningLiquid Biopsy

Keywords

Early Detection of CancerMCED

Outcome Measures

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

    assessed up to 60 months

Secondary Outcomes (3)

  • 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

    assessed up to 60 months

  • To assess test MERCURY's efficiency and clinical utility in average risk population

    assessed up to 60 months

  • To evaluate participants' attitude and perception towards MCED blood test

    assessed up to 60 months

Study Arms (1)

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

Interventions

MERCURY test, health questionnaires and annual routine physical examsOTHER

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 Intervention

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 、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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Nanjing Jiangbei People's Hospital

Nanjing, Jiangsu, 210000, China

RECRUITING

The Fourth Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210000, China

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Shao Yang, Ph.D

    NanjingShihejiyin Technology Inc.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shanshan Yang, Ph.D

CONTACT

8613585145836admin@geneseeq.com

Xuan Wang

CONTACT

8618392411194cohortstudy@geneseeq.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2023

First Posted

August 25, 2023

Study Start

June 15, 2022

Primary Completion (Estimated)

May 15, 2027

Study Completion (Estimated)

May 15, 2027

Last Updated

August 25, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)