Early Gastric CancerNCT04665687
Clinical Application of Genetic Sequencing of Early Gastric Cancer and Gastric Adenoma Patients
An observational study of Early Gastric Cancer and Gastric Adenoma, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
Because advanced gastric cancer shows poor prognosis, it is important to detect early gastric cancer or precancerous gastric adenoma patients who have a cure rate of 95% or more. Read more about this study
- Who is it for?
- Ages 19 to 100 years
- Conditions the study is for
- Early Gastric Cancer, Gastric Adenoma
- How many people
- 1,730 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 Dec 2020to 31 Dec 2031
- 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 19 to 100 years
- All sexes
- Adult, Older adult
Study population: A total of 1730 patients with early gastric cancer and precancerous gastric adenoma will be enrolled. Based on previous studies, approximately 20% of the subjects are expected to have mutations. In this study, metachronous tumor recurrence rate between the mutation group and non-mutation group will be compared. In general, metachronous tumor recurrent rate after endoscopic resection for early gastric cancer or gastric ademona is reported to be 6%-10%. In this study, the metachronous tumor recurrence rate is expected to be 10% and 5% in the mutation and non-mutation group, respectively. When a two-sided chi-square test with a power of 5% and 90% type 1 error is performed, 346 and 1384 subjected are expected to be included in the mutation group and non-mutation group, respectively.
Who may be able to join
- Those who are over the age of 19
- Those who were histologically confirmed with early gastric cancer or precancerous gastric adenoma
- Patients with early gastric cancer or precancerous gastric adenoma falling under the above criteria who have excess tissue stored from previous non-research purpose biopsy/endodoscopic removal for treatment and diagnosis
- Those whose life expectancy is more than 3 months
- Those who have voluntarily consented to participate in this clinical trial
Who cannot join
- Those who will not yield enough samples
- Those who are considered inappropriate for this study in the discretion of the researchers
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
Clinical Research Coordinator, 82234103409, hyejung1.cho@sbri.co.kr
About this study
Official title: Clinical Sequencing Project for Early Gastric Cancer and Precancerous Gastric Adenoma Patients for Personalized Cancer Clinic
Because advanced gastric cancer shows poor prognosis, it is important to detect early gastric cancer or precancerous gastric adenoma patients who have a cure rate of 95% or more. Moreover, a large part of early gastric cancer can be completely resected by endoscopic resection, thus ensuring a very high quality of life for patients. However, there are currently no markers that can be used for diagnosis of early gastric cancer or gastric adenoma. In addition, the biggest problem after endoscopic resection of early gastric cancer is metachronous recurrence of the cancer, which requires repeated endoscopic resection or additional surgical gastrectomy. However, there are no discovered markers for prediction of recurrence.
Liquid biopsy is a method of obtaining body fluids such as gastric juice or effusion through an endoscopic inlet during gastroscopy or colonoscopy and blood. Based on the advanced analysis method, liquid biopsy reveals more genetic information than tissue biopsy. Therefore, it is highly likely to become an essential factor in future personalized medicine. Therefore, this study was designed to identify whether tumor's molercular profiling based on tissue or blood could be used for prediction of prognosis and diagnosis of early gastric cancer and precancerous gastric adenoma.
Read the detailed description
- Acquisition of tumor samples : Tissue and 10ml of blood will be collected for genomic examination of those histologically diagnosed with early gastric cancer or precancerous gastric adenoma lesion, and additional tissue and blood will be collected at 2 months, 1 year after treatment, and recurrence.
- Suitability of tmor samples : Tumor areas (> 60%) are dissected under microscopy from 4-μm-thick unstained sections by comparison with an H\&E stained slide, and genomic DNA was extracted using a Qiagen DNA FFPE Tissue Kit (Qiagen, Hilden, Germany) according to the manufacturer's instructions. After extraction, we measured concentrations and 260/280 and 260/230 nm ratios using a spectrophotometer (ND1000, Nanodrop Technologies, ThermoFisher Scientific, MA, USA). Each sample was then quantified with an Qubit fluorometer (Life Technologies, Carlsbad, CA, USA). Samples of genomic DNA with more than 10 ng measured by the Qubit fluorometer were subjected to AmpliSeq library preparation. To identify "druggable" CNVs, we used a 21-gene nCounter CNV assay.
- Method of tumor molecular profiling
- Ion Torrent PGM Amplieq Cancer Panel 2.0 : We use the Ion AmpliSep Cancer Panel V2(Ion Torrent) to detect frequent somatic mutations that were selected based on literature review. It examines 285 mutations in 50 commonly mutated oncogenes and tumor supressor genes. First, 10ng of DNA from each 89 FFPE tumor samples underwent single-tube, multiplex PCR amplication using the Ion AmpliSepCancer Primer Pool and the AmpliSepKit reagents (Life Technologies).Treatment of the resulting amplicons with FuPa Preagent partially digest the primers and phosphorylate the amplicons. The phosphorylate the amplicons are ligated to Ion dapters and purfied. For barcoded library preparation, we substitite barcoded adapters from the Ion XpressTM Library Kit. The ligated DNA undergose nick translation and amplication to complete the linkage between adapters and amplicons and to generate sufficient material for dowmstream template treparation. Two rounds of Agencourt® AMPure® XP Reagent binding at 0.6 and 1.2 bead- to- sample volum ratios removed input DNA and unincorporated primers form the amplicons. The final library molecules are 125-300bp in size. We then transfer the libries to the Ion OneTouchTM system for automated template preparation. Sequencing is performed on the Ion PGMTM sequencer according to the manufacturer's instructions. We use IonTorrent Software for automated data analysis.
- nCounter copy Number Variation CodeSets : We custom designed a 21-gene CNV assay as outlined in a previous study. The 21 genes included AURAKA, CCND1, CCNE1, CDK4, CDK6, CDNK1A, CDNK2A, EGFR, ERBB2, ERBB3, FGFR1, FGFR2, IGFR1R, KLF5, KRAS, MDM2, MET, MITF, MYC, PIK3CA, and TNIK. For detection of CNVs, nCounter Copy Number Variation CodeSets were used with 200 ng purified genomic DNA. DNA was fragmented via AluI digestion and denatured at 95°C. Fragmented DNA was hybridized with the codeset of 21 genes in the nCounter Cancer CN Assay Kit (Nanostring Technologies) for 18 h at 65°C and processed according to the manufacturer's instructions. The nCounter Digital Analyzer counted and tabulated the signals of reporter probes. Quantified data were analyzed using NanoString's nSolver Analysis Software.
- Immunohistochemistry : RET, ATM, PD-L1, FGFR2, MLH, EGFR, ALK, ROS, TRKA. MET, HER2, PTEN loss (EGFR,CCNEI in selected cases)
- Cancer Scan : targeted deep sequencing at Samsung Genome Institute : Illumina HiSeq2000/2500-based, MiSeq NGS targeted sequencing
- ASFA™ Spotter
- Statistics : Analysis of genetic research is primarily technical. Data are presented using summary statistics tables and graphs. The total disease-free survival period is calculated by the Kaplan-Meier method through medical records of subjects who have undergone endoscopic resection.
- Conditions
- Early Gastric Cancer, Gastric Adenoma
- Medical subject headings
- Stomach Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify biomarkers for differential diagnosis between early gastric cancer and precancerous adenoma.
Tumor's moleular profiling is assessed by following method:
- Ion Torrent PGM Amplieq Canccer Panel 2.0
- Nanostring copy number variation (CNV) panel
- Immunohistochemistry: RET, ATM, PD-L1, FGFR2, MLH, EGFR, ALK, ROS, TRKA. MET, HER2, PTEN loss (EGFR,CCNEI in selected cases)
- Illumina HiSeq2000/2500-based, MiSeq NGS targeted sequencing
- ASFA™ Spotter
Measured: From the date of initial treatment until the date of first recurrence or up to 2 years, whichever came first.
Indentify prognostic biomarkers for predicting recurrence of early gastric cancer and precancerous adenoma lesion.
Comparison of tumor's molecular profile between the cases of recurrence and non-recurrence.
Tumor's moleular profiling is assessed by following method:
- Ion Torrent PGM Amplieq Canccer Panel 2.0
- Nanostring copy number variation (CNV) panel
- Immunohistochemistry: RET, ATM, PD-L1, FGFR2, MLH, EGFR, ALK, ROS, TRKA. MET, HER2, PTEN loss (EGFR,CCNEI in selected cases)
- Illumina HiSeq2000/2500-based, MiSeq NGS targeted sequencing
- ASFA™ Spotter
Measured: From the date of initial treatment until the date of first recurrence or up to 2 years, whichever came first.
Secondary outcomes (1)
Change in the tumor's molecular profile on serial biopsies at the time of initial treatment, 2 months after treatment, 1 year after treatment, or recurrence.
The method of tumor's moleular profiling is same as the above.
Measured: From the date of initial treatment until the date of first recurrence or up to 2 years, whichever came first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2020
- Study start17 Dec 2020
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early 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
- 1,730 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyuk Lee, Samsung Medical Center
- Investigators
- Hyuk Lee, MD, PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04665687
- Sponsor's protocol ID
- 2020-08-070-002
- Status last verified
- Sep 2025
- First submitted
- 8 Nov 2020
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Sequencing Project for Early Gastric Cancer and Precancerous Gastric Adenoma Patients for Personalized Cancer Clinic
- ClinicalTrials.gov ID
- NCT04665687
- Acronym / sponsor ID
- 2020-08-070-002
- Conditions
- Early Gastric Cancer, Gastric Adenoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,730 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 17 Dec 2020 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 14 Dec 2020 (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.
Because advanced gastric cancer shows poor prognosis, it is important to detect early gastric cancer or precancerous gastric adenoma patients who have a cure rate of 95% or more. Moreover, a large part of early gastric cancer can be completely resected by endoscopic resection, thus ensuring a very high quality of life for patients. However, there are currently no markers that can be used for diagnosis of early gastric cancer or gastric adenoma. In addition, the biggest problem after endoscopic resection of early gastric cancer is metachronous recurrence of the cancer, which requires repeated endoscopic resection or additional surgical gastrectomy. However, there are no discovered markers for prediction of recurrence.
Liquid biopsy is a method of obtaining body fluids such as gastric juice or effusion through an endoscopic inlet during gastroscopy or colonoscopy and blood. Based on the advanced analysis method, liquid biopsy reveals more genetic information than tissue biopsy. Therefore, it is highly likely to become an essential factor in future personalized medicine. Therefore, this study was designed to identify whether tumor's molercular profiling based on tissue or blood could be used for prediction of prognosis and diagnosis of early gastric cancer and precancerous gastric adenoma.
Detailed description
- Acquisition of tumor samples : Tissue and 10ml of blood will be collected for genomic examination of those histologically diagnosed with early gastric cancer or precancerous gastric adenoma lesion, and additional tissue and blood will be collected at 2 months, 1 year after treatment, and recurrence.
- Suitability of tmor samples : Tumor areas (> 60%) are dissected under microscopy from 4-μm-thick unstained sections by comparison with an H\&E stained slide, and genomic DNA was extracted using a Qiagen DNA FFPE Tissue Kit (Qiagen, Hilden, Germany) according to the manufacturer's instructions. After extraction, we measured concentrations and 260/280 and 260/230 nm ratios using a spectrophotometer (ND1000, Nanodrop Technologies, ThermoFisher Scientific, MA, USA). Each sample was then quantified with an Qubit fluorometer (Life Technologies, Carlsbad, CA, USA). Samples of genomic DNA with more than 10 ng measured by the Qubit fluorometer were subjected to AmpliSeq library preparation. To identify "druggable" CNVs, we used a 21-gene nCounter CNV assay.
- Method of tumor molecular profiling
- Ion Torrent PGM Amplieq Cancer Panel 2.0 : We use the Ion AmpliSep Cancer Panel V2(Ion Torrent) to detect frequent somatic mutations that were selected based on literature review. It examines 285 mutations in 50 commonly mutated oncogenes and tumor supressor genes. First, 10ng of DNA from each 89 FFPE tumor samples underwent single-tube, multiplex PCR amplication using the Ion AmpliSepCancer Primer Pool and the AmpliSepKit reagents (Life Technologies).Treatment of the resulting amplicons with FuPa Preagent partially digest the primers and phosphorylate the amplicons. The phosphorylate the amplicons are ligated to Ion dapters and purfied. For barcoded library preparation, we substitite barcoded adapters from the Ion XpressTM Library Kit. The ligated DNA undergose nick translation and amplication to complete the linkage between adapters and amplicons and to generate sufficient material for dowmstream template treparation. Two rounds of Agencourt® AMPure® XP Reagent binding at 0.6 and 1.2 bead- to- sample volum ratios removed input DNA and unincorporated primers form the amplicons. The final library molecules are 125-300bp in size. We then transfer the libries to the Ion OneTouchTM system for automated template preparation. Sequencing is performed on the Ion PGMTM sequencer according to the manufacturer's instructions. We use IonTorrent Software for automated data analysis.
- nCounter copy Number Variation CodeSets : We custom designed a 21-gene CNV assay as outlined in a previous study. The 21 genes included AURAKA, CCND1, CCNE1, CDK4, CDK6, CDNK1A, CDNK2A, EGFR, ERBB2, ERBB3, FGFR1, FGFR2, IGFR1R, KLF5, KRAS, MDM2, MET, MITF, MYC, PIK3CA, and TNIK. For detection of CNVs, nCounter Copy Number Variation CodeSets were used with 200 ng purified genomic DNA. DNA was fragmented via AluI digestion and denatured at 95°C. Fragmented DNA was hybridized with the codeset of 21 genes in the nCounter Cancer CN Assay Kit (Nanostring Technologies) for 18 h at 65°C and processed according to the manufacturer's instructions. The nCounter Digital Analyzer counted and tabulated the signals of reporter probes. Quantified data were analyzed using NanoString's nSolver Analysis Software.
- Immunohistochemistry : RET, ATM, PD-L1, FGFR2, MLH, EGFR, ALK, ROS, TRKA. MET, HER2, PTEN loss (EGFR,CCNEI in selected cases)
- Cancer Scan : targeted deep sequencing at Samsung Genome Institute : Illumina HiSeq2000/2500-based, MiSeq NGS targeted sequencing
- ASFA™ Spotter
- Statistics : Analysis of genetic research is primarily technical. Data are presented using summary statistics tables and graphs. The total disease-free survival period is calculated by the Kaplan-Meier method through medical records of subjects who have undergone endoscopic resection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- A total of 1730 patients with early gastric cancer and precancerous gastric adenoma will be enrolled. Based on previous studies, approximately 20% of the subjects are expected to have mutations. In this study, metachronous tumor recurrence rate between the mutation group and non-mutation group will be compared. In general, metachronous tumor recurrent rate after endoscopic resection for early gastric cancer or gastric ademona is reported to be 6%-10%. In this study, the metachronous tumor recurrence rate is expected to be 10% and 5% in the mutation and non-mutation group, respectively. When a two-sided chi-square test with a power of 5% and 90% type 1 error is performed, 346 and 1384 subjected are expected to be included in the mutation group and non-mutation group, respectively.
Key inclusion criteria (5 listed)
- Those who are over the age of 19
- Those who were histologically confirmed with early gastric cancer or precancerous gastric adenoma
- Patients with early gastric cancer or precancerous gastric adenoma falling under the above criteria who have excess tissue stored from previous non-research purpose biopsy/endodoscopic removal for treatment and diagnosis
- Those whose life expectancy is more than 3 months
- Those who have voluntarily consented to participate in this clinical trial
Key exclusion criteria (2 listed)
- Those who will not yield enough samples
- Those who are considered inappropriate for this study in the discretion of the researchers
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
Identify biomarkers for differential diagnosis between early gastric cancer and precancerous adenoma.
Time frame: From the date of initial treatment until the date of first recurrence or up to 2 years, whichever came first.
Tumor's moleular profiling is assessed by following method: 1. Ion Torrent PGM Amplieq Canccer Panel 2.0 2. Nanostring copy number variation (CNV) panel 3. Immunohistochemistry: RET, ATM, PD-L1, FGFR2, MLH, EGFR, ALK, ROS, TRKA. MET, HER2, PTEN loss (EGFR,CCNEI in selected cases) 4. Illumina HiSeq2000/2500-based, MiSeq NGS targeted sequencing 5. ASFA™ Spotter
Indentify prognostic biomarkers for predicting recurrence of early gastric cancer and precancerous adenoma lesion.
Time frame: From the date of initial treatment until the date of first recurrence or up to 2 years, whichever came first.
Comparison of tumor's molecular profile between the cases of recurrence and non-recurrence. Tumor's moleular profiling is assessed by following method: 1. Ion Torrent PGM Amplieq Canccer Panel 2.0 2. Nanostring copy number variation (CNV) panel 3. Immunohistochemistry: RET, ATM, PD-L1, FGFR2, MLH, EGFR, ALK, ROS, TRKA. MET, HER2, PTEN loss (EGFR,CCNEI in selected cases) 4. Illumina HiSeq2000/2500-based, MiSeq NGS targeted sequencing 5. ASFA™ Spotter
1 secondary outcome
Change in the tumor's molecular profile on serial biopsies at the time of initial treatment, 2 months after treatment, 1 year after treatment, or recurrence.
Time frame: From the date of initial treatment until the date of first recurrence or up to 2 years, whichever came first.
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 12 Sep 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Early Gastric Cancer
RecruitingObservational study
Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
RecruitingObservational study
cfDNA Assay Prospective Observational Validation for Early Cancer Detection and Minimal Residual Disease
Brain Cancer, Breast Cancer
RecruitingObservational study
68Ga-labeled Cholecystokinin Receptor (CCK2R) Targeted Molecular Probes in Early Tumor Diagnosis
Medullary Thyroid Carcinoma, Small Cell Lung Cancer ( SCLC )
Recruiting
SPADE Clinical Trial.
Early Gastric Cancer, Adenocarcinoma of the Stomach
Active, not recruitingObservational study
Early Recovery After Surgery Protocol in Improving Quality of Life in Participants With Stage 0-IIIC Gastric Cancer Undergoing Surgery
Clinical Stage 0 Gastric Cancer AJCC v8, Clinical Stage I Gastric Cancer AJCC v8
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.
Hyuk Lee, MD, PhD principal investigator
Samsung Medical Center
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 Early Gastric Cancer and Gastric Adenoma, 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 5 inclusion and 2 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 12 Sep 2025. 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?
Contact Clinical Research Coordinator (82234106853, hyejung1.cho@sbri.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify biomarkers for differential diagnosis between early gastric cancer and precancerous adenoma. (time frame: From the date of initial treatment until the date of first recurrence or up to 2 years, whichever came first.). The study lists 2 primary outcomes in all. 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 12 Sep 2025.