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CONCORDANCE: Study to Evaluate Concordance of Detecting EGFR (Epidermal Growth Factor Receptor) Mutation by Circulating Tumour Free DNA Versus Tissues Biopsy in NSCLC (Non-small Cell Lung Cancer).

Sponsor
AstraZeneca (Industry)
Overall Status
Completed
CT.gov ID
NCT03562819
Collaborator
(none)
268
Enrollment
14
Locations
9.7
Actual Duration (Months)
19.1
Patients Per Site
2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a multicentre, prospective, study of EGFR )Epidermal Growth Factor Receptor) mutation status in advanced NSCLC (Non-small cell lung cancer)patients (locally advanced and/or metastatic disease) with adenocarcinoma histology proposed to be conducted at 15 sites from different geographical regions across India. The study targets to enrol 268 patients over a period of 6 months.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This is a multicentre, prospective, study of EGFR mutation status in advanced NSCLC patients (locally advanced and/or metastatic disease) with adenocarcinoma histology proposed to be conducted at 15 sites from different geographical regions across India. The study targets to enrol 268 patients over a period of 6 months. The study will enroll patients with histologically confirmed, systemic treatment naïve adenocarcinoma metastatic cancer (stage IV). This will be a single visit study. No study medication will be prescribed or administered as a part of study procedure.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    268 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    An Observational, Multicentre, Prospective Study to Evaluate Concordance of Detecting EGFR (Epidermal Growth Factor Receptor) Mutation by Circulating Tumour Free DNA Versus Tissues Biopsy in NSCLC (Non-small Cell Lung Cancer).
    Actual Study Start Date :
    Aug 16, 2018
    Actual Primary Completion Date :
    Jun 7, 2019
    Actual Study Completion Date :
    Jun 7, 2019

    Arms and Interventions

    Arm Intervention/Treatment
    NSCLC

    Non-small cell lung cancer

    Outcome Measures

    Primary Outcome Measures

    1. Determine the level of concordance between EGFR mutation status [1 Day]

      by tissue and plasma based testing in terms of Overall Concordance, Sensitivity, specificity, Positive predictive value & negative predictive value.

    Secondary Outcome Measures

    1. Assess the frequency of T790M mutation among study patients. [1 Day]

      Frequency and percentage of TKI treatment naïve NSCLC patients with T790M mutation will be provided.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Patients who provide written informed consent

    2. Patients aged 18 years and older

    3. Newly diagnosed patients with Metastatic (stage IV) NSCLC.

    4. Histologically confirmed Adenocarcinoma NSCLC patient as per tissue biopsy and Tissue sample sent for EGFR mutation analysis OR result for EGFR mutation test is available from last 28 days from the date of enrolment.

    5. Patient should be naïve for any systemic treatment (i.e. no chemotherapy or EGFR-TKI)

    Exclusion Criteria:

    1. Patient with any medical condition that, in the opinion of the investigator, would interfere with outcome of the study

    2. Patient participating in any other interventional clinical study/trial.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Reserch Site Punjab Chandigarh India 160055
    2 Research Site New Delhi Delhi India 110029
    3 Research Site New Delhi Delhi India 110063
    4 Research Site New Delhi Delhi India 110085
    5 Research Site Bengaluru Karnataka India 560027
    6 Research Site Kerala Kozhikode India 673601
    7 Research Site Mumbai Maharashtra India 400012
    8 Research Site Mumbai Maharashtra India 400071
    9 Research Site Maharashtra Mumbai India 400016
    10 Research Site Bhubaneswar Odisha India 751007
    11 Research Site Hyderabad Telanagana India 500034
    12 Research Site Kolkata West Bangal India 700160
    13 Research Site Kolkata West Bengal India 700054
    14 Research Site Kolkata West Bengal India 700063

    Sponsors and Collaborators

    • AstraZeneca

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    AstraZeneca
    ClinicalTrials.gov Identifier:
    NCT03562819
    Other Study ID Numbers:
    • D5161R00003
    First Posted:
    Jun 20, 2018
    Last Update Posted:
    Jun 5, 2020
    Last Verified:
    Jun 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by AstraZeneca
    Epidermal Growth Factor Receptor
    Additional relevant MeSH terms:
    Lung Neoplasms
    Carcinoma, Non-Small-Cell Lung

    Study Results

    No Results Posted as of Jun 5, 2020