Genotyping of Non-small Cell Lung Cancer

NCT02002117 | Unknown

• 1 other identifier: 201103039RB
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Non-small Cell Lung Cancer; Gene Abnormality

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• determine the frequency by DNA mass spectrometry

  2 months

• response rate

  1 year

Study Arms (1)

DNA mass spectrometry

DNA mass spectrometry

Other: DNA mass

Interventions

DNA mass OTHER

DNA mass spectrometry

DNA mass spectrometry

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.
• Pathologic or cytological confirmation of non-small cell lung cancer (NSCLC) with available tissue
• Patients must understand and provide written informed consent prior to initiation of any study-specific procedures
• Have a life expectancy 3 months.
• Have stage IV NSCLC (AJCC, 7th Edition)
• 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.
• 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
• ≥20 years
• ECOG performance status 0 - 2
• 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.

You may not qualify if:

• 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.
• Known HIV infection.
• If subject has no archival tissue and refuse to do any biopsy or surgery for molecular testing

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

tissue and plasma

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Chih-Hsin Yang, PhD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2013
• First Posted: December 5, 2013
• Study Start: January 1, 2012
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2016
• Last Updated: July 30, 2014

Record last verified: 2014-07

Locations

TW (1)