CClinicalTrials.gg
Status unknownNCT02936804Updated Oct 19, 2016

Precision Diagnosis and Therapy for Early Stage Lung Cancer

An interventional study of Low Dose Computed Tomography in Lung Cancer, sponsored by Shanghai Chest Hospital. Status unknown at 1 site in China. Open to participants aged 45 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-10-19.

Sponsored by Shanghai Chest Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2016), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60,000
Allocation
Not applicable
Ages
45 Years to 70 Years
Sex
All
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Study 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.

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Conditions studied

  • Lung Cancer

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Keywords

  • early stage lung cancer
  • LDCT screening
  • lung resection
  • electromagnetic navigation bronchoscopy
  • peripheral biomarker
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In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's planned enrollment of 60,000 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Shanghai Chest Hospital is the lead sponsor of 194 studies on the registry; 94 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
45 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  1. Had a CT scan of chest within last 12 months
  2. History of any cancer within 5 years
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60,000 participants (estimated)

Study arms

  • 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.

    Device: Low Dose Computed Tomography

Interventions

  • DeviceLow Dose Computed Tomography

    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.

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What researchers measure

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.

    Time frame: 5 years

Secondary outcomes

  1. Lung cancer disease free survival

    Compared the disease-free survival (DFS) among different treatment strategy of early stage lung cancer.

    Time frame: 5 years

  2. Lung cancer mortality

    Assess lung cancer mortality within next 5 years after first round of screening

    Time frame: 5 years

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Study locations

1 site
  • Shanghai Chest hospital
    Shanghai, Shanghai 200030, China
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 19, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02936804
Lead sponsor
Shanghai Chest Hospital
Responsible party
Baohui Han (: Vice-President, Shanghai Chest Hospital) — Principal investigator
First posted
Oct 18, 2016
Start date
Dec 2016
Primary completion
Dec 2018 (estimated)
Completion
Dec 2020 (estimated)
Last update
Oct 19, 2016

Study contacts

Baohui Han, MD, PhD
Contact
xkyyhan@gmail.com
86-21-62821990 ext. 3301
Yanwei Zhang, MD, PhD
Contact
zhangyw198691@163.com
86-21-62821990 ext. 3306
Baohui Han, MD, PhD
principal investigator · Shanghai Chest Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.

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