Clinical trial NCT03562819: 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).
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).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: NSCLC (Non-small Cell Lung Cancer)
Keywords: Epidermal Growth Factor Receptor
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2018-06-20
Enrollment: 268
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: NSCLC (Non-small cell lung cancer)

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Determine the level of concordance between EGFR mutation status
timeFrame: 1 Day
Secondary outcomes:
measure: Assess the frequency of T790M mutation among study patients.
timeFrame: 1 Day
Other outcomes:
Locations:
city: Punjab
country: India
facility: Reserch Site
state: Chandigarh
city: New Delhi
country: India
facility: Research Site
state: Delhi
city: New Delhi
country: India
facility: Research Site
state: Delhi
city: New Delhi
country: India
facility: Research Site
state: Delhi
city: Bengaluru
country: India
facility: Research Site
state: Karnataka
city: Kerala
country: India
facility: Research Site
state: Kozhikode
city: Mumbai
country: India
facility: Research Site
state: Maharashtra
city: Mumbai
country: India
facility: Research Site
state: Maharashtra
city: Maharashtra
country: India
facility: Research Site
state: Mumbai
city: Bhubaneswar
country: India
facility: Research Site
state: Odisha
city: Hyderabad
country: India
facility: Research Site
state: Telanagana
city: Kolkata
country: India
facility: Research Site
state: West Bangal
city: Kolkata
country: India
facility: Research Site
state: West Bengal
city: Kolkata
country: India
facility: Research Site
state: West Bengal
Study officials:
References:
citation: 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.