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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
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

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:

  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

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

First Posted
September 9, 2013
Last Updated
July 28, 2014
Sponsor
National Taiwan University Hospital
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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
No

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
No
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
Email
yaying0508@ntuh.gov.tw
First Name & Middle Initial & Last Name & Degree
Chih-Hsin Yang, PhD

12. IPD Sharing Statement

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Genotyping of Non-small Cell Lung Cancer

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