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Hematologic TestsNCT04230200

Prospective Screening Programme for Malignant Tumors

An observational study of Hematologic Tests and Malignant Tumor, run by Sun Yat-sen University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Hematologic Tests, Malignant Tumor
How many people
10,000 participants
Where
1 siteChina
Study dates
28 Mar 2017to 30 Mar 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

  • 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
  • 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

Who cannot join

  • 1.With a history of malignant disease
  • For the cohort of patients with malignancy

Trial locations and contacts

1 site in 1 country.

China1 site

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

Other trials in China

About this study

Official title: 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.

Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04230200
Study groupRoleWhat they receive
Healthy cohortPeople 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 CohortPeople 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. sensitivity (true positive rate)

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

    Measured: 1 year

  2. Specificity (true negative rate)

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

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2020
  2. Study start28 Mar 2017
  3. Primary completion30 Mar 2019
  4. Study completion30 Mar 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
10,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04230200
Sponsor's protocol ID
SCREEN-Pan Cancer
Status last verified
Jan 2020
First submitted
13 Jan 2020
Last updated
22 Jan 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 25651787

  • 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.

    PubMed 28130846

  • 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.

    PubMed 28792880

Questions about this trial

What is this clinical trial studying?

An observational study of Hematologic Tests and Malignant Tumor, run by Sun Yat-sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

sensitivity (true positive rate) (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04230200, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2020.

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