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Genotyping of Non-small Cell Lung Cancer

Primary Purpose

Non-small Cell Lung Cancer, Gene Abnormality

Status

Unknown status

Phase

Locations

Taiwan

Study Type

Observational

Intervention

DNA mass

About this trial

This is an observational trial for Non-small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.
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
≥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.

Exclusion Criteria:

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

Sites / Locations

National Taiwan University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Arm Label

DNA mass spectrometry

Arm Description

DNA mass spectrometry

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT02002117

First Posted

September 9, 2013

Last Updated

July 28, 2014

Sponsor

National Taiwan University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02002117

Brief Title

Genotyping of Non-small Cell Lung Cancer

Official Title

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

Study Type

Observational

2. Study Status

Record Verification Date

July 2014

Overall Recruitment Status

Unknown status

Study Start Date

January 2012 (undefined)

Primary Completion Date

April 2015 (Anticipated)

Study Completion Date

April 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Taiwan University Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-small Cell Lung Cancer, Gene Abnormality

7. Study Design

Enrollment

100 (Anticipated)

Biospecimen Retention

Samples With DNA

Biospecimen Description

tissue and plasma

8. Arms, Groups, and Interventions

Arm Title

DNA mass spectrometry

Arm Description

DNA mass spectrometry

Intervention Type

Other

Intervention Name(s)

DNA mass

Intervention Description

DNA mass spectrometry

Primary Outcome Measure Information:

Title

frequency of individual genotyping

Description

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.

Time Frame

2 months

Secondary Outcome Measure Information:

Title

determine the frequency by DNA mass spectrometry

Description

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.

Time Frame

2 months

Title

response rate

Description

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.

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. 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 ≥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. Exclusion Criteria: 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

Study Population Description

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.

Sampling Method

Probability Sample

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chih-Hsin Yang, PhD

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Taiwan University Hospital

City

Taipei

ZIP/Postal Code

100

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yaying Bai, MSc

Phone

889911572423

yaying0508@ntuh.gov.tw

First Name & Middle Initial & Last Name & Degree

Chih-Hsin Yang, PhD

12. IPD Sharing Statement

Learn more about this trial

Genotyping of Non-small Cell Lung Cancer

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