To hear about similar clinical trials, please enter your email below
Trial Title:
The Jinling Cohort
NCT ID:
NCT06011694
Condition:
Cancer
Multi Cancer Early Screening
Liquid Biopsy
Conditions: Keywords:
Early Detection of Cancer
MCED
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
MERCURY test, health questionnaires and annual routine physical exams
Description:
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.
Arm group label:
No Intervention
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.
Criteria for eligibility:
Study pop:
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
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
45 Years
Maximum age:
75 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Nanjing Jiangbei People's Hospital
Address:
City:
Nanjing
Zip:
210000
Country:
China
Status:
Recruiting
Contact:
Last name:
Jianbei Huang
Phone:
+8618951766697
Facility:
Name:
The Fourth Affiliated Hospital of Nanjing Medical University
Address:
City:
Nanjing
Zip:
210000
Country:
China
Status:
Recruiting
Contact:
Last name:
Yuan Mao, Ph.D
Phone:
+8613951918531
Start date:
June 15, 2022
Completion date:
May 15, 2027
Lead sponsor:
Agency:
Nanjing Shihejiyin Technology, Inc.
Agency class:
Industry
Source:
Nanjing Shihejiyin Technology, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06011694
