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CompletedNCT03562819CONCORDANCEUpdated Jun 5, 2020

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).

An observational study in NSCLC (Non-small Cell Lung Cancer), sponsored by AstraZeneca. Completed at 14 sites in India. Per ClinicalTrials.gov, last updated 2020-06-05.

Sponsored by AstraZeneca · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
268
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • NSCLC (Non-small Cell Lung Cancer)

Keywords

  • Epidermal Growth Factor Receptor
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In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's enrollment of 268 is above the median of 189 across 1,514 observational studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 358 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

NSCLC (Non-small cell lung cancer)

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

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.
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Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
268 participants (actual)
Patient registry
No

Groups and cohorts

  • NSCLC

    Non-small cell lung cancer

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What researchers measure

Primary outcomes

  1. Determine the level of concordance between EGFR mutation status

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

    Time frame: 1 Day

Secondary outcomes

  1. Assess the frequency of T790M mutation among study patients.

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

    Time frame: 1 Day

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Study locations

14 sites
  • Reserch Site
    Punjab, Chandigarh 160055, India
  • Research Site
    New Delhi, Delhi 110029, India
  • Research Site
    New Delhi, Delhi 110063, India
  • Research Site
    New Delhi, Delhi 110085, India
  • Research Site
    Bengaluru, Karnataka 560027, India
  • Research Site
    Kerala, Kozhikode 673601, India
  • Research Site
    Mumbai, Maharashtra 400012, India
  • Research Site
    Mumbai, Maharashtra 400071, India
  • Research Site
    Maharashtra, Mumbai 400016, India
  • Research Site
    Bhubaneswar, Odisha 751007, India
  • Research Site
    Hyderabad, Telanagana 500034, India
  • Research Site
    Kolkata, West Bangal 700160, India
  • Research Site
    Kolkata, West Bengal 700054, India
  • Research Site
    Kolkata, West Bengal 700063, India
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References and documents

Publications

  • Prabhash K, Biswas B, Khurana S, Batra U, Biswas G, Advani SH, Mohapatra PN, Rajappa S, Sharma A, Patil S, Dattatreya PS, Roy R, Almel S, Goyal G, Warrier N. CONCORDANCE: A real-world evidence study to evaluate the concordance of detecting epidermal growth factor receptor (EGFR) mutation by circulating tumor DNA* versus tissue biopsy in patients with metastatic non-small cell lung cancer. Indian J Cancer. 2022 Mar;59(Supplement):S11-S18. doi: 10.4103/ijc.ijc_438_21. PubMed 35343188 ↗

Related links

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 5, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03562819
Lead sponsor
AstraZeneca
Responsible party
Sponsor
First posted
Jun 20, 2018
Start date
Aug 16, 2018
Primary completion
Jun 7, 2019
Completion
Jun 7, 2019
Last update
Jun 5, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

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