Genotyping of Non-small Cell Lung Cancer

Genotyping of Non-small Cell Lung Cancer Cells - A Study of Taiwan Lung Cancer Clinical Trial Consortium (TALCC)

The logical next step is to integrate molecular profiling into the care of all patients with NSCLC.

Study Overview

• Status: Unknown
• Conditions: Non-small Cell Lung Cancer; Gene Abnormality
• Intervention / Treatment: Other: DNA mass

Detailed Description

NSCLC is an area of oncology in which clinicians are beginning to use specific tumor-associated molecular aberrations to assign and/or prioritize targeted therapies for patients. At this early stage, multiple hurdles remain before molecular profiling becomes a routine part of thoracic oncology practice. In particular, to develop specific targeted therapies for patients whose tumors harbor rare mutations, it will be important to identify appropriate candidates, design the appropriate trials, and execute the trials with adequate numbers to achieve the necessary endpoints. Implementation will facilitate realization of the promise of molecularly tailored therapy, which could lead to more effective treatments with fewer side effects.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • Recruiting
    • National Taiwan University Hospital
    • Contact: Yaying Bai, MSc; Phone Number: 889911572423; Email: yaying0508@ntuh.gov.tw
    • Principal Investigator: Chih-Hsin Yang, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

We plan to collect 300 EGFR mutation positive samples (approximately 200 de novo, 100 after treatment), 200 EGFR wild type adenocarcinoma patients and 100 other NSCLC patients in 3 years.

Description

Inclusion Criteria:

1. Patients who have participated or will be participating a lung cancer clinical trial that use EGFR-TKI or chemotherapy as first line or second line treatment.
2. Pathologic or cytological confirmation of non-small cell lung cancer (NSCLC) with available tissue
3. Patients must understand and provide written informed consent prior to initiation of any study-specific procedures
4. Have a life expectancy 3 months.
5. Have stage IV NSCLC (AJCC, 7th Edition)

6. No or one prior systemic therapy for advanced or metastatic NSCLC 6.1.Adjuvant chemotherapy: The adjuvant chemotherapy (e.g. vinorelbine / cisplatin) should be counted as one prior systemic therapy if the interval between the completion of adjuvant chemotherapy and the documentation of recurrence within 12 months.

   6.2.Maintenance therapy: The maintenance therapy (e.g. pemetrexed) following the first-line systemic chemotherapy which achieved complete response, partial response, or stable disease should not be counted as one prior systemic therapy if the maintenance drug was used in first-line combination therapy

7. ≥20 years
8. ECOG performance status 0 - 2
9. If there is no available archived tissue, the subject must consent to undergo a biopsy or surgical procedure to obtain tissue within 1 month prior to study entry, which may or may not be part of the patient's routine care for their malignancy.

Exclusion Criteria:

1. Prior history of another malignancy (other than cured basal cell carcinoma of the skin or cured in-situ carcinoma of the cervix) within 5 years of study entry.
2. Known HIV infection.
3. If subject has no archival tissue and refuse to do any biopsy or surgery for molecular testing

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
DNA mass spectrometry	Other: DNA mass; DNA mass spectrometry

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
frequency of individual genotyping	To determine the frequency of individual genotyping in cancer cells of advanced non-small cell lung cancer (NSCLC) patients who have participated or will commence the clinical trial.	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
determine the frequency by DNA mass spectrometry	To determine the frequency with which molecular profiling of a NSCLC patient's tumor by DNA mass spectrometry yields a target against which there is approved or investigational therapeutic regimen.	2 months
response rate	To determine the response rate according to RECIST, progression-free, and overall survival in patients with advanced NSCLC whose therapy is selected by molecular profile.	1 year

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Chih-Hsin Yang, PhD

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Anticipated): April 1, 2015
• Study Completion (Anticipated): April 1, 2016

Study Registration Dates

• First Submitted: September 9, 2013
• First Submitted That Met QC Criteria: November 29, 2013
• First Posted (Estimate): December 5, 2013

Study Record Updates

• Last Update Posted (Estimate): July 30, 2014
• Last Update Submitted That Met QC Criteria: July 28, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: 201103039RB