Genomic Analysis to Identify a Predictive Biomarker for Immunotherapy

Recruiting

• Conditions: Lung Cancer

• Registration Number: NCT03578185
• Lead Sponsor: Se-Hoon Lee

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

Study Timeline

• Study Start: 2018-04-11
• Study First Submitted: 2018-06-25
• Study First Submitted QC: 2018-07-05
• Study First Posted: 2018-07-06
• Primary Completion: 2020-12-31
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-29
• Last Update Posted: 2024-12-03
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 800

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
List of biomarkers	Baseline	Neoantigen, tumor mutation burden, MHC compatibility, T-cell receptor and associated immune gene signature (IFN-r, interferons such as IL-2 and interleukin family), T-cell subset (T cell surface marker such as CD4+, CD7+, CD8+, CD16, CD34+, CD38+, CD56+, etc.), PD-1/PD-L1 expression, etc.

Trial Locations

Locations (3)

Asan Medical Center; 🇰🇷 Seoul, Songpa-gu, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Joungro-gu, Korea, Republic of

Samsung Medical Center; 🇰🇷 Seoul, Gangnam-gu, Korea, Republic of