Prospective Screening Programme for Malignant Tumors

Overview

In prospective part of study, the investigators have found that the parameters of routine blood tests can differentiate varieties of malignancy from healthy people. The investigators enrolled healthy subjects and patients with malignancy that aged from 18 to 85,and collected their clinical data and blood tests result to build the model.And retrospectlly enroll healthy subjects and patients to test the model.

Full Title of Study: “A Large-scale, Prospective Screening Programme for Malignant Tumors Using Routine Blood Tests Parameters”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Other
  • Study Primary Completion Date: March 30, 2019

Arms, Groups and Cohorts

  • Healthy cohort
    • People who received routine physical examination including blood test, and after 3 year follow-up, have not been diagnosed as any kind of malignant tumor.
  • Malignancy Cohort
    • People who were diagnosed as one of the following malignant disease: breast cancer, lung cancer, gastric cancer, esophageal cancer,colorectal cancer,nasopharyngeal cancer,liver cancer and cervical cancer

Clinical Trial Outcome Measures

Primary Measures

  • sensitivity (true positive rate)
    • Time Frame: 1 year
    • The proportion of persons with disease who have a positive test (positive test results among persons with disease)
  • Specificity (true negative rate)
    • Time Frame: 1 year
    • The proportion of persons without disease who have a negative test (negative test results among persons without disease)

Participating in This Clinical Trial

For the cohort of healthy people Inclusion Criteria:

1. Asymptomatic persons between the ages of 18 to 80 years 2. Chinese ethnicity 3. After 3 year follow-up, diagnosed with no malignant disease 4. Subject underwent routine blood tests in our center Exclusion Criteria:

1.With a history of malignant disease For the cohort of patients with malignancy Inclusion Criteria:

1. diagnosis with the following malignant disease,breast cancer, lung cancer, gastric cancer, esophageal cancer,colorectal cancer,nasopharyngeal cancer,liver cancer and cervical cancer 2. Subject underwent routine blood tests in our center

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Sun Yat-sen University
  • Collaborator
    • First Affiliated Hospital, Sun Yat-Sen University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ruihua Xu, President – Sun Yat-sen University
  • Overall Official(s)
    • Ruihua Xu, Doctor, Principal Investigator, Sun Yat-sen University

References

Torre LA, Bray F, Siegel RL, Ferlay J, Lortet-Tieulent J, Jemal A. Global cancer statistics, 2012. CA Cancer J Clin. 2015 Mar;65(2):87-108. doi: 10.3322/caac.21262. Epub 2015 Feb 4.

Heimbach JK, Kulik LM, Finn RS, Sirlin CB, Abecassis MM, Roberts LR, Zhu AX, Murad MH, Marrero JA. AASLD guidelines for the treatment of hepatocellular carcinoma. Hepatology. 2018 Jan;67(1):358-380. doi: 10.1002/hep.29086. No abstract available.

Chan KCA, Woo JKS, King A, Zee BCY, Lam WKJ, Chan SL, Chu SWI, Mak C, Tse IOL, Leung SYM, Chan G, Hui EP, Ma BBY, Chiu RWK, Leung SF, van Hasselt AC, Chan ATC, Lo YMD. Analysis of Plasma Epstein-Barr Virus DNA to Screen for Nasopharyngeal Cancer. N Engl J Med. 2017 Aug 10;377(6):513-522. doi: 10.1056/NEJMoa1701717. Erratum In: N Engl J Med. 2018 Mar 8;378(10 ):973.

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