Precision Diagnosis and Therapy for Early Stage Lung Cancer

NCT02936804 | Unknown DMC

• 1 other identifier: Chest002
• Study Type: interventional
• Target: 60,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Keywords

early stage lung cancer; LDCT screening; lung resection; electromagnetic navigation bronchoscopy; peripheral biomarker

Outcome Measures

Primary Outcomes (1)

• 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.

  5 years

Secondary Outcomes (2)

• Lung cancer disease free survival

  5 years

• Lung cancer mortality

  5 years

Study Arms (1)

Screening Arm

EXPERIMENTAL

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.

Device: Low Dose Computed Tomography

Interventions

Low Dose Computed Tomography DEVICE

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.

Screening Arm

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Had a CT scan of chest within last 12 months
• History of any cancer within 5 years

Sponsors & Collaborators

• Shanghai Chest Hospital: lead

Study Sites (1)

Shanghai Chest hospital

Shanghai, Shanghai Municipality, 200030, China

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Tomography, X-Ray Computed

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography

Study Officials

• Baohui Han, MD, PhD

  Shanghai Chest Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Baohui Han, MD, PhD

CONTACT

86-21-62821990; xkyyhan@gmail.com

Yanwei Zhang, MD, PhD

CONTACT

86-21-62821990; zhangyw198691@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: : Vice-President

Study Record Dates

• First Submitted: October 15, 2016
• First Posted: October 18, 2016
• Study Start: December 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2020
• Last Updated: October 19, 2016

Record last verified: 2016-10

Locations

CN (1)