Clinical trial NCT04230200: Prospective Screening Programme for Malignant Tumors
Official title: A Large-scale, Prospective Screening Programme for Malignant Tumors Using Routine Blood Tests Parameters
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hematologic Tests
Malignant Tumor
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: First Affiliated Hospital, Sun Yat-Sen University
name: Sixth Affiliated Hospital, Sun Yat-sen University
First posted: 2020-01-18
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: sensitivity (true positive rate)
timeFrame: 1 year
measure: Specificity (true negative rate)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Ruihua Xu, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
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.
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. No abstract available.
citation: 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.