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Correlation Between EGFR Mutation Using cfDNAs and Circulating Tumor Cells in Patients With NSCLC

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ClinicalTrials.gov Identifier: NCT02422628
Recruitment Status : Unknown
Verified December 2016 by National Taiwan University Hospital.
Recruitment status was:  Enrolling by invitation
First Posted : April 21, 2015
Last Update Posted : December 14, 2016
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief Summary:
Correlation of epithelial growth factor receptor mutation in blood of lung cancer patient and clinical outcome.

Condition or disease
Lung Cancer

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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Correlation Between Epithelial Growth Factor Receptor(EGFR) Mutation Using cfDNA and CTCs in Patients With Non-Small Cell Lung Cancer
Study Start Date : April 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Group/Cohort
EGFR mutation postive
Blood samples every 3 months till disease progression or intolerable due to side effect.
EGFR mutation wild type
Blood samples before treatment once.
Healthy Volunteers
Blood samples once.



Primary Outcome Measures :
  1. Progressive disease measured by RECIST criteria after receiving 1st line EGFR-TKI [ Time Frame: 3 years ]

Biospecimen Retention:   Samples With DNA
Blood samples every 3 months till disease progression or intolerable due to side effect.


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients with NSCLC adenocarcinoma
Criteria

NSCLC patients should fulfill the following criteria:

  1. Provision of informed consent prior to any study specific procedures
  2. Patients with non-small cell lung cancer, adenocarcinoma, aged 20 years and older.
  3. Tumor harboring EGFR mutation including activating mutation L858R, Del19 or/and resistant mutation T790M, or/and rare mutation G719, S768, L861
  4. Treatment naive
  5. Patients will receive EGFR-TKI as first line treatment.

For inclusion in the study of control subjects (100 volunteers), they should fulfill the following criteria:

  1. Provision of informed consent prior to any study specific procedures
  2. Patients aged 20 years and older
  3. Volunteers without any lung cancer related diagnosis or symptoms
  4. EGFR TKI treatment naïve and without any EGFR TKI treatment in the following process

For inclusion in the study of control subjects (100 EGFR wild-type), they should fulfill the following criteria:

  1. Provision of informed consent prior to any study specific procedures
  2. Patients with non-small cell lung cancer, adenocarcinoma, aged 20 years and older.
  3. Tumor with no EGFR mutation detected (mutation L858R, Del19 or/and resistant mutation T790M, or/and rare mutation G719, S768, L861)
  4. EGFR TKI treatment naïve and without any EGFR TKI treatment in the following process

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Exclusion criteria

For exclusion in the study of NSCLC patients and control subjects should fulfill the following criteria:

  1. Subjects should not enter the study if any of the following exclusion criteria are fulfilled: Involvement in the planning and/or conduct of the study (applies to staff at the study site)
  2. Previous enrolment in the present study
  3. As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease)
  4. Evidence of any other significant clinical disorder or laboratory finding that made it undesirable for the patient to participate in the study
  5. Pregnancy or breast-feeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02422628


Locations
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Taiwan
National Taiwan University Hospital
Taipei city, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Principal Investigator: Chao-Chi Ho National Taiwan University Hospital No. 7, Chung-Shan South Road, Taipei, Taiwan
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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT02422628    
Other Study ID Numbers: 201304074RIPC
First Posted: April 21, 2015    Key Record Dates
Last Update Posted: December 14, 2016
Last Verified: December 2016
Keywords provided by National Taiwan University Hospital:
EGFR inhibitor
EGFR mutation
EGFR
adenocarcinoma
EGFR TKI
treatment
Non small cell
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases