The Jinling Cohort
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age45-75
SponsorNanjing Shihejiyin Technology, Inc.
About this trial
The Jinling Cohort is a prospective, multicenter cohort study in which 15,000 eligible individuals aged 45-75 in Nanjing China will be enrolled.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
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;
Trial 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
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
MERCURY test, health questionnaires and annual routine physical exams
Other interventionEach 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.
Treatment groups
15,000 Participants
are divided into 1 treatment groupGroup A: No Intervention1 intervention
Trial outcomes
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
Time frame
assessed up to 60 monthsSecondary outcomes
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
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
Time frame
assessed up to 60 months2
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.
Time frame
assessed up to 60 months3
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
Time frame
assessed up to 60 monthsSponsors and contacts
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Source ClinicalTrials.gov