The Jinling Cohort

Официальное название

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

Обзор

The Jinling Cohort is a prospective, multicenter cohort study in which 15,000 eligible individuals aged 45-75 in Nanjing China will be enrolled.

Подробное описание

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.

Вмешательства

• Другое 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.

Первичные конечные точки

• 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 [Срок оценки: assessed up to 60 months]

Вторичные конечные точки (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 [Срок оценки: assessed up to 60 months]
• To assess test MERCURY's efficiency and clinical utility in average risk population [Срок оценки: assessed up to 60 months]
• To evaluate participants' attitude and perception towards MCED blood test [Срок оценки: assessed up to 60 months]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 2 центра

• Nanjing Jiangbei People's Hospital — Нанкин
• The Fourth Affiliated Hospital of Nanjing Medical University — Нанкин

Идентификаторы

NCT: NCT06011694 · NanjingShihejiyinTech

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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