- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02936804
Precision Diagnosis and Therapy for Early Stage Lung Cancer
October 17, 2016 updated by: Baohui Han, Shanghai Chest Hospital
Key Technology in Precision Diagnosis and Therapy for Early Stage Lung Cancer: a Single Arm Clinical Trial
The present study is a single arm clinical trial aiming to improve the key technology in the diagnosis and treatment of early stage lung cancer.
60,000 high-risk subjects (age 45-70) are planned to recruit and assign to the Low Dose Computed Tomography (LDCT) screening arm (Baseline + 2 rounds of biennial repeated LDCT screening).
Management of positive screening test will be carried out by a pre-specified protocol.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
60000
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Baohui Han, MD, PhD
- Phone Number: 3301 86-21-62821990
- Email: xkyyhan@gmail.com
Study Contact Backup
- Name: Yanwei Zhang, MD, PhD
- Phone Number: 3306 86-21-62821990
- Email: zhangyw198691@163.com
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200030
- Shanghai Chest Hospital
-
Contact:
- Baohui Han, MD,PhD
- Phone Number: 3301 86-21-62821990
- Email: xkyyhan@gmail.com
-
Contact:
- Yanwei Zhang, MD,PhD
- Phone Number: 3306 86-21-62821990
- Email: zhangyw198691@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
• Eligible participants were those aged 45-70 years, and with either of the following risk factors:
- history of cigarette smoking ≥ 20 pack-years, and, if former smokers, had quit within the previous 15 years;
- malignant tumors history in immediate family members;
- personal cancer history;
- professional exposure to carcinogens;
- long term exposure to second-hand smoke;
- long term exposure to cooking oil fumes.
Exclusion Criteria:
- Had a CT scan of chest within last 12 months
- History of any cancer within 5 years
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Screening Arm
Low Dose Computed Tomography (LDCT) was performed at baseline + 2 rounds of biennial repeated LDCT.
Management of positive screening test will be carried out by a pre-specified protocol.
|
LDCT was performed at baseline and 2 rounds of biennial repeated LDCT.
The abnormal nodules were defined as noncalcified nodules (NCN) larger than 4 mm.
The management of abnormal nodules including precision diagnosis by endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA), electromagnetic navigation bronchoscope (ENB) and peripheral biomarkers, and precision therapy by intraoperative frozen section guided lung resection and ENB radiofrequency ablation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lung cancer incidence rate
Time Frame: 5 years
|
Assess the number of lung cancer incidences after each round of screening.
Compared the stage differences between screening arm and natural incidence.
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lung cancer disease free survival
Time Frame: 5 years
|
Compared the disease-free survival (DFS) among different treatment strategy of early stage lung cancer.
|
5 years
|
Lung cancer mortality
Time Frame: 5 years
|
Assess lung cancer mortality within next 5 years after first round of screening
|
5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Baohui Han, MD, PhD, Shanghai Chest Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2016
Primary Completion (Anticipated)
December 1, 2018
Study Completion (Anticipated)
December 1, 2020
Study Registration Dates
First Submitted
October 15, 2016
First Submitted That Met QC Criteria
October 15, 2016
First Posted (Estimate)
October 18, 2016
Study Record Updates
Last Update Posted (Estimate)
October 19, 2016
Last Update Submitted That Met QC Criteria
October 17, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Chest002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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