Clinical trial NCT03578185: Genomic Analysis to Identify a Predictive Biomarker for Immunotherapy
Official title: Genomic Analysis to Identify a Predictive Biomarker for Immunotherapy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Cancer
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2018-07-06
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Total of 800 lung cancer patients treated with immune checkpoint inhibitor Study will be initiated from the date of IRB approval to Dec. 2020 for those who signed for master agreement for tissue donation for research purposes.

Brief summary: This study is designed to identify the predictive biomarker for immunotherapy using patient samples (tumor tissue, blood, fecal material) who treated with immune checkpoint inhibitor.

Detailed description: \[Sample acquisition\]

* Informed consent is waived for those who agree to donate samples left over from other clinical trials or acquired for other purposes to be used for other research by the sign to master agreement in advance.
* The study will be conducted based on the purposes indicated in the master agreement signed by tissue donator \[Clinical data acquisition\]
* Baseline demographics: Sex, Birth date, expire date (last follow-up date for the survivals)
* Lung cancer treatment history: diagnosed date, treatment history (surgery, radiation therapy, chemotherapy, immunotherapy treatment history, and responses), general performance, metastatic sites
* Lung cancer histologic information: pathology, histologic subtype, EGFR mutation profile, ALK-rearrangement result

Eligibility criteria: Inclusion Criteria:

1. aged above or equal to 18
2. Histologically confirmed lung cancer patients
3. Patient treated with immune checkpoint inhibitor

Exculsion Criteria:

NA

Primary outcomes:
measure: List of biomarkers
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Gangnam-gu
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Joungro-gu
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Songpa-gu
Study officials:
affiliation: Samsung Medical Center
name: Se-hoon Lee, MD
role: STUDY_CHAIR
References:
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