Gastric CancerSMC-4SNCT07911267
Development and Utilization of an Integrated Clinical Genomic Database
An observational study of Gastric Cancer and Colorectal Cancer, run by Samsung Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Gastric Cancer, Colorectal Cancer, Lung Cancer (NSCLC)
- How many people
- 118,750 participants
- Where
- 1 siteSouth Korea
- Study dates
- 6 Dec 2024to 31 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, Gang-Nam, 06351
Kyung Han Na, RN, +82-2-2148-9848, kyunghan.na@sbri.co.kr
About this study
Official title: Development and Utilization of a Comprehensive Genetic-Clinical Database
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.
Read more
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.
- Medical subject headings
- Stomach Neoplasms, Colorectal Neoplasms, Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Liver Neoplasms, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| IM6 | Hematology-Oncology | |
| IM1 | Gastroenterology | |
| OP | Surgery | |
| RT | Radiation Oncology |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From study enrollment through December 31, 2030
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start6 Dec 2024
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 118,750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeeyun Lee, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07911267
- Sponsor's protocol ID
- 2024-11-107
- Acronym
- SMC-4S
- Status last verified
- Oct 2026
- First submitted
- 22 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Utilization of a Comprehensive Genetic-Clinical Database
- ClinicalTrials.gov ID
- NCT07911267
- Acronym / sponsor ID
- SMC-4S / 2024-11-107
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 118,750 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 6 Dec 2024 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 2 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| IM6 | – | –Hematology-Oncology |
| IM1 | – | –Gastroenterology |
| OP | – | –Surgery |
| RT | – | –Radiation Oncology |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Participants with Integrated Genomic and Clinical Data
Time frame: From study enrollment through December 31, 2030
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer and Colorectal Cancer, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Integrated Genomic and Clinical Data (time frame: From study enrollment through December 31, 2030). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.