China Lung Cancer Screening (CLUS) Study Version 2.0

NCT ID: NCT03975504

Last Updated: 2022-06-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

6000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-01

Study Completion Date

2023-07-31

Brief Summary

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Our previous study, china lung cancer screening study version 1.0, had proven that LDCT led to a 74.1% increase in detecting early-stage lung cancer compare to usual care (NCT02898441). The present one arm study is performed to evaluate the efficacy of new techniques in improving the implementation of lung cancer screening and validate our previous findings. 6000 high-risk subjects (age 45-75) were recruited to take LDCT screening. (Baseline + 2 biennial repeated LDCT screening). Follow-up for lung cancer incidence, lung cancer mortality and overall mortality was performed. Blood samples were stored in a Biobank. Management of positive screening test was carried out by a pre-specified protocol.

Detailed Description

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Conditions

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Lung Neoplasms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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LDCT Screening

LDCT was performed at baseline + 2 biennial repeated LDCT rounds

Group Type OTHER

Low Dose Computed Tomography

Intervention Type DEVICE

LDCT were performed in screening arm. The abnormal nodules were defined as noncalcified nodules (NCN) larger than 5 mm

artificial intelligence (AI)

Intervention Type DEVICE

AI was performed in high-risk individuals recruitment and lung nodules management

autofluorescence imaging (AFI)

Intervention Type DIAGNOSTIC_TEST

AFI applied in screening of centrally located SCC.

Interventions

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Low Dose Computed Tomography

LDCT were performed in screening arm. The abnormal nodules were defined as noncalcified nodules (NCN) larger than 5 mm

Intervention Type DEVICE

artificial intelligence (AI)

AI was performed in high-risk individuals recruitment and lung nodules management

Intervention Type DEVICE

autofluorescence imaging (AFI)

AFI applied in screening of centrally located SCC.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Eligible participants were those aged 45-75 years, and with either of the following risk factors:

1. history of cigarette smoking ≥ 20 pack-years, and, if former smokers, had quit within the previous 15 years;
2. malignant tumors history in immediate family members;
3. personal cancer history;
4. professional exposure to carcinogens;
5. long term exposure to second-hand smoke;
6. long term exposure to cooking oil fumes.

Exclusion Criteria

1. Had a CT scan of chest within last 12 months
2. History of any cancer within 5 years
Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shanghai Chest Hospital

OTHER

Sponsor Role lead

Responsible Party

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Baohui Han

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Shanghai Chest hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Baohui Han, MD Dr.

Role: CONTACT

8618930858216

Yanwei Zhang, MD Dr.

Role: CONTACT

8618930599895

Facility Contacts

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Baohui Han

Role: primary

8618930858216 ext. 8618930858216

References

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Zhang Y, Liu W, Zhang H, Sun B, Chen T, Hu M, Zhou H, Cao Y, Han B, Wu L. Extracellular vesicle long RNA markers of early-stage lung adenocarcinoma. Int J Cancer. 2023 Apr 1;152(7):1490-1500. doi: 10.1002/ijc.34386. Epub 2022 Dec 15.

Reference Type DERIVED
PMID: 36451312 (View on PubMed)

Other Identifiers

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CHEST1809

Identifier Type: -

Identifier Source: org_study_id

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