search
Back to results

Precision Diagnosis and Therapy for Early Stage Lung Cancer

Primary Purpose

Lung Cancer

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Low Dose Computed Tomography
Sponsored by
Shanghai Chest Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring early stage lung cancer, LDCT screening, lung resection, electromagnetic navigation bronchoscopy, peripheral biomarker

Eligibility Criteria

45 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

• Eligible participants were those aged 45-70 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

Sites / Locations

  • Shanghai Chest hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Screening Arm

Arm Description

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.

Outcomes

Primary Outcome Measures

Lung cancer incidence rate
Assess the number of lung cancer incidences after each round of screening. Compared the stage differences between screening arm and natural incidence.

Secondary Outcome Measures

Lung cancer disease free survival
Compared the disease-free survival (DFS) among different treatment strategy of early stage lung cancer.
Lung cancer mortality
Assess lung cancer mortality within next 5 years after first round of screening

Full Information

First Posted
October 15, 2016
Last Updated
October 17, 2016
Sponsor
Shanghai Chest Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT02936804
Brief Title
Precision Diagnosis and Therapy for Early Stage Lung Cancer
Official Title
Key Technology in Precision Diagnosis and Therapy for Early Stage Lung Cancer: a Single Arm Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2016 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Chest Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
early stage lung cancer, LDCT screening, lung resection, electromagnetic navigation bronchoscopy, peripheral biomarker

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Screening Arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Low Dose Computed Tomography
Intervention Description
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.
Primary Outcome Measure Information:
Title
Lung cancer incidence rate
Description
Assess the number of lung cancer incidences after each round of screening. Compared the stage differences between screening arm and natural incidence.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Lung cancer disease free survival
Description
Compared the disease-free survival (DFS) among different treatment strategy of early stage lung cancer.
Time Frame
5 years
Title
Lung cancer mortality
Description
Assess lung cancer mortality within next 5 years after first round of screening
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Baohui Han, MD, PhD
Phone
86-21-62821990
Ext
3301
Email
xkyyhan@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yanwei Zhang, MD, PhD
Phone
86-21-62821990
Ext
3306
Email
zhangyw198691@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Baohui Han, MD, PhD
Organizational Affiliation
Shanghai Chest Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Chest hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Baohui Han, MD,PhD
Phone
86-21-62821990
Ext
3301
Email
xkyyhan@gmail.com
First Name & Middle Initial & Last Name & Degree
Yanwei Zhang, MD,PhD
Phone
86-21-62821990
Ext
3306
Email
zhangyw198691@163.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Precision Diagnosis and Therapy for Early Stage Lung Cancer

We'll reach out to this number within 24 hrs