NCT02941003

Brief Summary

The purpose of this study is:

  1. 1.To establish a set of diagnostic criteria of intraoperative frozen section of early stage lung adenocarcinoma, including clinicopathologic and molecular characteristics.
  2. 2.To assess its clinical usefulness in guiding surgical procedure for early stage lung adenocarcinoma.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
540

participants targeted

Target at P75+ for not_applicable lung-cancer

Timeline
Completed

Started Feb 2016

Typical duration for not_applicable lung-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 19, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 21, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

October 27, 2016

Status Verified

October 1, 2016

Enrollment Period

2.8 years

First QC Date

October 19, 2016

Last Update Submit

October 25, 2016

Conditions

Lung Cancer

Keywords

Early stage lung adenocarcinomaIntraoperative frozen sectionDiagnostic criteria

Outcome Measures

Primary Outcomes (1)

  • Comparison of histopathological characteristics between intraoperative frozen section and paraffin section for patients with early stage lung adenocarcinoma

    6 months

Secondary Outcomes (3)

  • Detection of CD31/CD34, D2-40, Ki67 and p53 among different subtypes of early stage lung adenocarcinoma by immunohistochemical (IHC) analysis

    6 months

  • Comparison of mutation profiles among different subtypes of early stage lung adenocarcinoma by tissue microdissection and subsequent next generation sequencing (NGS)

    6 months

  • Verification of the driver mutations from NGS results using droplet digital PCR (ddPCR) in early stage lung adenocarcinoma.

    3 months

Study Arms (2)

OCT treatment

EXPERIMENTAL

Randomly assigned patients whose small pulmonary nodules are inflated with the diluted OCT medium (2:3) used for frozen section, and then detected under microscope for their histopathological characteristics, by immunostaining for specific protein expression, by NGS (next-generation sequencing) for driver mutations.

Device: microscopeOther: immunostainingDevice: NGS

OCT free

EXPERIMENTAL

Randomly assigned patients whose small pulmonary nodules are uninflated with OCT used for frozen section, and then detected under microscope for their histopathological characteristics, by immunostaining for specific protein expression, by NGS for driver mutations.

Device: microscopeOther: immunostainingDevice: NGS

Interventions

microscopeDEVICE

Detection of of histopathological characteristics of OCT treatment or OCT free samples from patients .

OCT freeOCT treatment
immunostainingOTHER

Detection of CD31/CD34, D2-40, Ki67 and p53 immunostaining of OCT treatment or OCT free samples from patients .

OCT freeOCT treatment
NGSDEVICE

The investigators used the device to detect the gene mutations of OCT treatment or OCT free samples obtained from part of the patients.

Also known as: Illumina Nexseq500
OCT freeOCT treatment

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with suspected pulmonary nodules (5\~20 mm) by chest CT scan;
  • Patients received surgical operation.

You may not qualify if:

  • Patients compliance is poor and cannot accept follow-up;
  • Patients nursing or pregnant;
  • Patients with a history of any cancer;
  • Patients with confirmed pathological diagnosis or received radiotherapy or chemotherapy or target therapy preoperatively.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Jie Zhang, MD, MS.

    Shanghai Chest Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jie Zhang, MD, MS

CONTACT

(+86)1801732157218017321572@163.com

Keke Yu, MD, PhD

CONTACT

(+86)18930859590ykkxx@shchest.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Physician

Study Record Dates

First Submitted

October 19, 2016

First Posted

October 21, 2016

Study Start

February 1, 2016

Primary Completion

December 1, 2018

Study Completion

October 1, 2019

Last Updated

October 27, 2016

Record last verified: 2016-10

Locations

CN(1)