Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT03578185
NCT03578185RecruitingNot Applicable

Genomic Analysis to Identify a Predictive Biomarker for Immunotherapy

Samsung Medical Center3 sites in 1 country2,000 target enrollmentStarted: April 11, 2018Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
2,000
Locations
3
Primary Endpoint
List of biomarkers
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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 Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Se-Hoon Lee

Professor

Samsung Medical Center

Study Sites (3)

Loading locations...

Similar Trials

Completed
Phase 4
Identification of Predictive Biomarkers for Response to Biologic Therapies and Tofacitinib in Inflammatory Bowel DiseaseInflammatory Bowel DiseasesUlcerative ColitisCrohn Disease
NCT03885713Fundación de Investigación Biomédica - Hospital Universitario de La Princesa180
Recruiting
Phase 2
Evaluation of Treatment Predictors Reflecting Beta-catenin Activation in Hepatocellular CarcinomaHepatocellular Carcinoma Non-resectable
NCT04965454Queen's Medical Center80
Unknown
Phase 2
Study on the Biomarker of First-line Immunotherapy Combined With Chemotherapy in Advanced Esophageal CancerAdvanced Esophageal Cancer
NCT05174156Sixth Affiliated Hospital, Sun Yat-sen University50
Completed
Not Applicable
Selecting Specific Bio-markers and Researching Mechanisms of Immune Regulation From Inhalation Injury and Traumatic Lung Injury Based on Single Cell Sequencing TechnologyTraumatic Lung InjuryInhalation Injury
NCT05718830Changhai Hospital21
Completed
Not Applicable
Predictive Gene Profiles and Dynamic Measurement of Treatment Response in Metastatic Non-small Cell Lung CancerMetastatic Nonsmall Cell Lung Cancer
NCT03512847Zealand University Hospital150
Genomic Analysis to Identify a Predictive... | Clinical Trial