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

Non Small Cell Lung Cancer Clinical Trial

— CHOICE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02113852
• Other study ID #: CTONG 1308
• Status: Completed
• Phase: N/A
• First received: March 24, 2014
• Last updated: February 28, 2017
• Start date: August 2013
• Est. completion date: December 2016

Study information

• Verified date: February 2017
• Source: Guangdong Association of Clinical Trials
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: December 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong Association of Clinical Trials

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 years
Secondary	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.	2 years