CancerNCT06011694
The Jinling Cohort
An observational study of Cancer and Multi Cancer Early Screening, run by Nanjing Shihejiyin Technology, Inc. at 2 sites in China.
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. Read more about this study
- Who is it for?
- Ages 45 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer, Multi Cancer Early Screening, Liquid Biopsy
- What is being tested?
- MERCURY test, health questionnaires and annual routine physical exams
- How many people
- 15,000 participants
- Where
- 2 sitesChina
- Study dates
- 15 Jun 2022to 15 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Nanjing Jiangbei People's Hospital
Nanjing, Jiangsu, 210000
Jianbei Huang, +8618951766697
- Recruiting
The Fourth Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210000
Yuan Mao, Ph.D, +8613951918531
About this study
Official title: A Prospective, Multicenter Cohort Study of the Multi-omics Liquid Biopsy MCED Test MERCURY in an Average Risk Chinese Population
The Jinling Cohort is a prospective, multicenter cohort study in which 15,000 eligible individuals aged 45-75 in Nanjing China will be enrolled.
Read the 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.
- Conditions
- Cancer, Multi Cancer Early Screening, Liquid Biopsy
- Being tested
- MERCURY test, health questionnaires and annual routine physical exams
- Keywords
- Early Detection of Cancer, MCED
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: MERCURY test, health questionnaires and annual routine physical exams |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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
Measured: assessed up to 60 months
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.
Measured: assessed up to 60 months
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
Measured: assessed up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study start15 Jun 2022
- Primary completion15 May 2027 (estimated)
- Study completion15 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Shihejiyin Technology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shao Yang, Ph.D, Principal investigator, NanjingShihejiyin Technology Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06011694
- Sponsor's protocol ID
- NanjingShihejiyinTech
- Status last verified
- Aug 2023
- First submitted
- 9 Aug 2023
- Last updated
- 25 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter Cohort Study of the Multi-omics Liquid Biopsy MCED Test MERCURY in an Average Risk Chinese Population
- ClinicalTrials.gov ID
- NCT06011694
- Acronym / sponsor ID
- NanjingShihejiyinTech
- Conditions
- Cancer, Multi Cancer Early Screening, Liquid Biopsy
- Keywords
- Early Detection of Cancer, MCED
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 15,000 participants (estimated)
- Lead sponsor
- Nanjing Shihejiyin Technology, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 15 May 2027 (estimated)
- Study completion
- 15 May 2027 (estimated)
- First posted
- 25 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No Intervention | – | Other: MERCURY test, health questionnaires and annual routine physical examsEach 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. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MERCURY test, health questionnaires and annual routine physical examsEach 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 | No Intervention |
Primary outcome
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 months
3 secondary outcomes
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
Time frame: assessed up to 60 months
To assess test MERCURY's efficiency and clinical utility in average risk population
Time frame: assessed up to 60 months
To evaluate participants' attitude and perception towards MCED blood test
Time frame: assessed up to 60 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shao Yang, Ph.D principal investigator
NanjingShihejiyin Technology Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Multi Cancer Early Screening, run by Nanjing Shihejiyin Technology, Inc. at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shanshan Yang, Ph.D (8613585145836, admin@geneseeq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: assessed up to 60 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2023.