Prospective Screening Programme for Malignant Tumors

Malignant Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04230200
• Other study ID #: SCREEN-Pan Cancer
• Status: Active, not recruiting
• Start date: March 28, 2017
• Est. completion date: March 30, 2020

Study information

• Verified date: January 2020
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10000
• Est. completion date: March 30, 2020
• Est. primary completion date: March 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Hematologic Tests
• Malignant Tumor
• Neoplasms

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (3)

Lead Sponsor	Collaborator
Sun Yat-sen University	First Affiliated Hospital, Sun Yat-Sen University, Sixth Affiliated Hospital, Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sensitivity (true positive rate)	The proportion of persons with disease who have a positive test (positive test results among persons with disease)	1 year
Primary	Specificity (true negative rate)	The proportion of persons without disease who have a negative test (negative test results among persons without disease)	1 year