ClinicalTrials.gg
RecruitingNCT07911267SMC-4SUpdated Nov 2, 2026

Development and Utilization of an Integrated Clinical Genomic Database

An observational study in Gastric Cancer, Colorectal Cancer and Lung Cancer (NSCLC), sponsored by Samsung Medical Center. Recruiting at 1 site in South Korea. Per ClinicalTrials.gov, last updated 2026-11-02.

Sponsored by Samsung Medical Center · Observational

From the registry’s dates

  • Started Dec 2024; still recruiting 1 year 11 months later.
Updated Nov 2, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
118,750
Sex
All
01

Study summary

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.

Read the detailed 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.

02

Conditions studied

03

In context

Stomach Neoplasms

3,399 studies on the registry are indexed under Stomach Neoplasms; 992 are open to participants now.

This study's planned enrollment of 118,750 is above the median of 278 across 790 observational studies indexed under Stomach Neoplasms.

Browse Stomach Neoplasms studies →

Lead sponsor

Samsung Medical Center is the lead sponsor of 1,011 studies on the registry; 152 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

The study population includes adults aged 19 years or older receiving care or undergoing routine health screening at Samsung Medical Center. Eligible participants include patients with diagnosed or suspected cancer undergoing clinically indicated tissue collection, healthy individuals undergoing routine health screening, and individuals at high risk of gastric or pancreatic cancer. Previously collected tissue and blood specimens from the Samsung Medical Center Biobank and approved research studies may also be included in accordance with applicable consent and ethical requirements. Clinical information and biospecimens will be collected and analyzed to establish an integrated genomic and clinical database for cancer biomarker discovery and treatment response prediction.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
118,750 participants (estimated)
Patient registry
No

Groups and cohorts

  • IM6

    Hematology-Oncology

  • IM1

    Gastroenterology

  • OP

    Surgery

  • RT

    Radiation Oncology

06

What researchers measure

Primary outcomes

  1. Number of Participants with Integrated Genomic and Clinical Data

    The number of participants with successfully generated genomic or molecular data linked to clinical information in an integrated database will be assessed. Genomic and molecular data will be obtained from tumor tissue and blood specimens, and linked to clinical information including cancer diagnosis, disease stage, treatment history, treatment response, and clinical outcomes. The integrated database will be used to support biomarker discovery and the development of predictive models for cancer diagnosis and treatment response.

    Time frame: From study enrollment through December 31, 2030

07

Study locations

1 of 1 sites recruiting
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Nov 2, 2026
Show all 1 update
  1. Nov 2, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07911267
Responsible party
Jeeyun Lee (Principal investigator, Samsung Medical Center) — Principal investigator
First posted
Nov 2, 2026
Start date
Dec 6, 2024
Primary completion
Dec 31, 2030 (estimated)
Completion
Dec 31, 2030 (estimated)
Last update
Nov 2, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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