Prospective Screening Programme for Malignant Tumors

January 17, 2020 updated by: Ruihua Xu, Sun Yat-sen University

A Large-scale, Prospective Screening Programme for Malignant Tumors Using Routine Blood Tests Parameters

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Sun Yat-sen University Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Malignant tumor is a common Threat to human health worldwide. Some of the routine blood tests parameters were reportedly predictive of the risk of Malignant tumor. This study aims to investigate whether routine blood tests parameters would be useful in the screening of Malignant tumor in asymptomatic individuals.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
1 year
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)
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Collaborators

First Affiliated Hospital, Sun Yat-Sen University
Sixth Affiliated Hospital, Sun Yat-sen University

Investigators

  • Principal Investigator: Ruihua Xu, Doctor, Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 28, 2017

Primary Completion (Actual)

March 30, 2019

Study Completion (Anticipated)

March 30, 2020

Study Registration Dates

First Submitted

January 13, 2020

First Submitted That Met QC Criteria

January 13, 2020

First Posted (Actual)

January 18, 2020

Study Record Updates

Last Update Posted (Actual)

January 22, 2020

Last Update Submitted That Met QC Criteria

January 17, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCREEN-Pan Cancer

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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