NCT04230200

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 28, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2019

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 18, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2020

Completed
Last Updated

January 22, 2020

Status Verified

January 1, 2020

Enrollment Period

2 years

First QC Date

January 13, 2020

Last Update Submit

January 17, 2020

Conditions

Hematologic TestsMalignant Tumor

Outcome Measures

Primary Outcomes (2)

  • sensitivity (true positive rate)

    The proportion of persons with disease who have a positive test (positive test results among persons with disease)

    1 year

  • Specificity (true negative rate)

    The proportion of persons without disease who have a negative test (negative test results among persons without disease)

    1 year

Study Arms (2)

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

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • With a history of malignant disease
  • For the cohort of patients with malignancy
  • diagnosis with the following malignant disease，breast cancer, lung cancer, gastric cancer， esophageal cancer，colorectal cancer，nasopharyngeal cancer，liver cancer and cervical cancer
  • Subject underwent routine blood tests in our center

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Related Publications (3)

  • 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.

    PMID: 25651787BACKGROUND

  • 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.

    PMID: 28130846BACKGROUND

  • 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.

    PMID: 28792880BACKGROUND

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Ruihua Xu, Doctor

    Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
President

Study Record Dates

First Submitted

January 13, 2020

First Posted

January 18, 2020

Study Start

March 28, 2017

Primary Completion

March 30, 2019

Study Completion

March 30, 2020

Last Updated

January 22, 2020

Record last verified: 2020-01

Locations

CN(1)