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Development and Utilization of an Integrated Clinical Genomic Database

Development and Utilization of an Integrated Clinical Genomic Database

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Overview

This observational study aims to develop an integrated genomic and clinical database to support the discovery and validation of biomarkers for cancer diagnosis, treatment selection, and prediction of treatment response.

The study will include adults aged 19 years or older with diagnosed or suspected cancer, as well as consenting individuals undergoing routine health screenings at Samsung Medical Center. Researchers will collect residual tissue specimens obtained during routine diagnostic or therapeutic procedures and additional blood samples collected alongside routine clinical blood tests. Previously collected specimens from approved biobank resources may also be used.

Genetic, molecular, and protein analyses will be performed on the collected specimens, and the results will be integrated with clinical information, including cancer diagnosis, treatment history, treatment response, and disease outcomes. Patient-derived organoids and immune cells may also be used to investigate drug responses in laboratory models.

The study aims to identify biomarkers associated with cancer development, progression, and treatment response, and to support the development of diagnostic tools and personalized treatment strategies.

No experimental treatments will be assigned as part of this study, and no additional tissue biopsies will be performed solely for research purposes.

Description

This is an investigator-initiated, observational study conducted at Samsung Medical Center to establish and utilize a comprehensive database integrating genomic, molecular, and clinical information. The primary objective is to discover and validate biomarkers associated with cancer diagnosis, disease progression, treatment response, and therapeutic outcomes.

The study aims to support precision oncology by identifying molecular characteristics associated with different clinical outcomes and developing predictive models for cancer diagnosis and treatment selection.

Eligibility

Inclusion Criteria:

  • Adults aged 19 years or older.
  • Patients diagnosed with or suspected of having cancer who are scheduled to undergo tissue collection for diagnostic, surgical, or therapeutic purposes.
  • Individuals undergoing routine health screening at Samsung Medical Center who voluntarily provide informed consent to participate in the study.
  • Patients who voluntarily provide informed consent to participate in the study, including consent for genetic analysis.
  • Individuals whose previously collected tissue or blood specimens are available through the Samsung Medical Center Biobank, including specimens from patients with gastric, colorectal, liver, pancreatic, biliary tract, lung, breast, esophageal, hematologic, or kidney cancers, in accordance with applicable consent and ethical requirements.
  • Participants previously enrolled in an approved research study (IRB File No. 2020-02-015) whose stored biospecimens remain within the approved retention period and for whom consent for secondary use has been obtained. Additional consent is not required for these specimens when permitted under the approved protocol.

Exclusion Criteria:

  • Individuals considered unsuitable for study participation at the investigator's discretion.
  • Participants who withdraw their consent after enrollment.
  • Participants from previously approved research studies whose biospecimen retention period has expired or who did not consent to secondary use of their specimens.

Study details
    Gastric Cancer
    Colorectal Cancer
    Lung Cancer (NSCLC)
    Liver Cancer
    Pancreatic Cancer

NCT07911267

Samsung Medical Center

7 November 2026

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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