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CompletedNCT02113852CHOICEUpdated Mar 1, 2017

Study of Blood, Tumor and Adjacent Normal Tissue Samples From Chinese Smoking Induced Lung Cancer Patients

An observational study in Non Small Cell Lung Cancer, sponsored by Guangdong Association of Clinical Trials. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-03-01.

Sponsored by Guangdong Association of Clinical Trials · Observational

Study type
Observational
Model
Other
Time perspective
Other
Enrollment
250
Ages
18 Years and older
Sex
All
01

Study summary

This is an epidemiological,multicenter study of genomic and expression profiles of patients with newly diagnosed NSCLC.Two hundred and fifty NSCLC patients who fulfill the criteria are to be recruited by investigational sites.Approximately 100 of them will be from retrospectively collected samples with detailed clinical and 2-year follow-up information after surgeries.The demographics,cancer/adjacent normal tissue and matched blood sample will be collected after the patient had provided informed consent.All tissue samples will be analyzed for somatic mutations by exome deep sequencing,mRNA expression profiling by RNA sequencing and chromosome copy number variation by SNP array at the designated laboratories.

Read the detailed description

The 2-year follow-up information of all enrolled patients will be collected every 6 months.

02

Conditions studied

  • Non Small Cell Lung Cancer

Keywords

  • Non small cell Lung Cancer
  • Heavy smokers
  • Treatment naive patients
03

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 enrollment of 250 is above the median of 189 across 1,514 observational studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Guangdong Association of Clinical Trials is the lead sponsor of 53 studies on the registry; 18 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

The study aims to collect approximately 250 smoking induced lung cancer(NSCLC) samples.Approximately 200 cases of treatment naive samples will be required. Samples will be collected mainly from the investigational sites in Guangzhou, Shanghai and Beijing that have expertise in lung cancer diagnosis.

Inclusion criteria

  1. Provision of written informed consent.
  2. Male or female aged≥18 years.
  3. .Histological or cytologically confirmed primary NSCLC,including histological subtypes:adenocarcinoma,squamous cell carcinoma and large cell carcinoma etc.
  4. .Provision of surgical specimen and blood sample.The retrospective samples will be collected between 2006and 2012 from the bio-bank.
  5. Patients must be willing to provide detailed clinical information (sex,age,geographic place,tumor stage,grade,size,smoking history,treatment history if any and outcome data).
  6. Heavy smokers(defined as having smoked 20 pack-years or more).
  7. Treatment naive patients:No prior chemotherapy,biological,immunological therapy or radical radiotherapy is permitted.

Exclusion criteria

Exclusion Criteria:

  • Not applicable
05

Study design

Observational model
Other
Time perspective
Other
Enrollment
250 participants (actual)
Target follow-up
2 Years
Patient registry
Yes
Biospecimen retention
Samples with dna
06

What researchers measure

Primary outcomes

  1. whole genome copy number variation in NSCLC patients

    To indentify and characterize somatic mutations in coding region (exome) in NSCLC patients through next generation sequencing of the tumor and blood samples.To identify and characterize whole genome copy number variation in NSCLC patients by using the standard SNP array(Affymetrix SNP 6.0).To indentify and characterize the transcriptome of tumor versus adjacent normal tissues by using RNA sequencing.

    Time frame: 2 years

Secondary outcomes

  1. Establish more effective therapy for lung cancer treatment in the future

    To identify the changes in molecular pathways and biomarker related to smoking induced lung cancer to help establish more effective therapy for lung cancer treatment in the future.

    Time frame: 2 years

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 1, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02113852
Lead sponsor
Guangdong Association of Clinical Trials
Responsible party
Sponsor
First posted
Apr 15, 2014
Start date
Aug 2013
Primary completion
May 2016
Completion
Dec 2016
Last update
Mar 1, 2017

Study contacts

Yi-Long Wu, MD
principal investigator · Guangdong Lung Cancer Institute, Guangdong General Hospital, Guangdong Academy of Medical Sciences

Oversight

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

Not currently enrolling

This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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