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NCT Number: NCT03578185

Genomic Analysis to Identify a Predictive Biomarker for Immunotherapy

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.

Recruiting

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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Samsung Medical Center, Seoul, Gangnam-gu, South Korea

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About this study

[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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • aged above or equal to 18
  • Histologically confirmed lung cancer patients
  • Patient treated with immune checkpoint inhibitor

Exculsion Criteria:

NA

Treatment and study plan

Primary outcomes

  1. List of biomarkers

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jinhee Seo

CONTACT

[email protected]

+82-70-7014-4158

Se-hoon Lee, MD

CONTACT

[email protected]

+82-10-4759-7640

Sponsors and collaborators

Lead sponsor

Se-Hoon Lee

Other

Registry information

Acronym: LC_Biomarker

Important dates

Study start
2018
Primary completion
2020
Study completion
2025
First posted
Jul 6, 2018
Registry last updated
Dec 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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