Gastric CancerNCT06521528
A Pilot Clinical Study to Evaluate the Feasibility of Using the SPC Test
An observational study of Gastric Cancer, run by Novomics. Co., Ltd. at 1 site in South Korea.
Trial summary
Precision medicine approaches emphasize the importance of reliable prognostic tools for guiding individualized therapy decisions. In this study, we evaluated the clinical feasibility of the Single Patient Classifier (SPC) test, a new clinical-grade prognostic assay, in stage II-III gastric cancer patients. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- nProfiler I Stomach Cancer Assay Kit
- Type of treatment
- Medical device
- How many people
- 237 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Sep 2019to 31 Dec 2025
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: histologically confirmed diagnosis of stage II or III AGC
Who may be able to join
- being ≥19 years of age
- having a histologically confirmed diagnosis of stage II or III AGC according to the American Joint Committee on Cancer (AJCC) staging system (sixth edition)
- underwent radical gastrectomy without prior neo-adjuvant chemoradiotherapy and did not receive adjuvant chemotherapy
- having no visually or microscopically detectable residual tumors.
Who cannot join
- -Those with insufficient quantity or quality of ribonucleic acid (RNA) for analysis were excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Clinical Study to Evaluate the Feasibility of Using the Single Patient Classifier as a Prognostic Test in Stage II-III Gastric Cancer Patients.
Precision medicine approaches emphasize the importance of reliable prognostic tools for guiding individualized therapy decisions. In this study, we evaluated the clinical feasibility of the Single Patient Classifier (SPC) test, a new clinical-grade prognostic assay, in stage II-III gastric cancer patients.
Read the detailed description
A prospective multicenter study was conducted, involving 237 patients who underwent gastrectomy between September 2019 and August 2020 across nine hospitals. The SPC test was employed to stratify patients into risk groups, and its feasibility and performance were evaluated. The primary endpoint was the proportion of the cases in which the test results were timely delivered before selecting postoperative treatment. Furthermore, 3-year disease-free survivals of risk groups were analyzed.
- Conditions
- Gastric Cancer
- Being tested
- nProfiler I Stomach Cancer Assay Kit
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nProfiler I Stomach Cancer Assay KitDevice
nProfiler I Stomach Cancer Assay Kit (Novomics Co., Korea)
| Study group | Role | What they receive |
|---|---|---|
| Feasibility cohort | patients who underwent gastrectomy between September 2019 and August 2020 across nine hospitals. Receives: Device: nProfiler I Stomach Cancer Assay Kit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timely delivered proportion
the proportion of the cases in which the test results were timely delivered before selecting postoperative treatment
Measured: 14 days
Secondary outcomes (2)
3-year disease free survival of the enrolled patients.
Statistical significance (P value of <0.05)
Measured: 3-years after the enrollment completion
5-year overall survival of the enrolled patients.
Statistical significance (P value of <0.05)
Measured: 5-years after the enrollment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start1 Sep 2019
- Primary completion30 Aug 2020
- Study completion31 Dec 2025 (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.
- 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
- 237 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Novomics. Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Young-Woo Kim, MD., Ph.D, Principal investigator, National Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06521528
- Sponsor's protocol ID
- Feasibility Study
- Status last verified
- Jul 2024
- First submitted
- 22 Jul 2024
- Last updated
- 29 Jul 2024
- 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 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Clinical Study to Evaluate the Feasibility of Using the Single Patient Classifier as a Prognostic Test in Stage II-III Gastric Cancer Patients.
- ClinicalTrials.gov ID
- NCT06521528
- Acronym / sponsor ID
- Feasibility Study
- Conditions
- Gastric Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 237 participants (actual)
- Lead sponsor
- Novomics. Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 30 Aug 2020 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 26 Jul 2024 (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.
Precision medicine approaches emphasize the importance of reliable prognostic tools for guiding individualized therapy decisions. In this study, we evaluated the clinical feasibility of the Single Patient Classifier (SPC) test, a new clinical-grade prognostic assay, in stage II-III gastric cancer patients.
Detailed description
A prospective multicenter study was conducted, involving 237 patients who underwent gastrectomy between September 2019 and August 2020 across nine hospitals. The SPC test was employed to stratify patients into risk groups, and its feasibility and performance were evaluated. The primary endpoint was the proportion of the cases in which the test results were timely delivered before selecting postoperative treatment. Furthermore, 3-year disease-free survivals of risk groups were analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Feasibility cohort | – | Device: nProfiler I Stomach Cancer Assay Kitpatients who underwent gastrectomy between September 2019 and August 2020 across nine hospitals. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- histologically confirmed diagnosis of stage II or III AGC
Key inclusion criteria (4 listed)
- being ≥19 years of age
- having a histologically confirmed diagnosis of stage II or III AGC according to the American Joint Committee on Cancer (AJCC) staging system (sixth edition)
- underwent radical gastrectomy without prior neo-adjuvant chemoradiotherapy and did not receive adjuvant chemotherapy
- having no visually or microscopically detectable residual tumors.
Key exclusion criteria (1 listed)
- -Those with insufficient quantity or quality of ribonucleic acid (RNA) for analysis were excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nProfiler I Stomach Cancer Assay KitnProfiler I Stomach Cancer Assay Kit (Novomics Co., Korea) | Device | Feasibility cohort |
Primary outcome
Timely delivered proportion
Time frame: 14 days
the proportion of the cases in which the test results were timely delivered before selecting postoperative treatment
2 secondary outcomes
3-year disease free survival of the enrolled patients.
Time frame: 3-years after the enrollment completion
5-year overall survival of the enrolled patients.
Time frame: 5-years after the enrollment completion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2024.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Young-Woo Kim, MD., Ph.D principal investigator
National Cancer 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 Gastric Cancer, run by Novomics. Co., Ltd. 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 4 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 29 Jul 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timely delivered proportion (time frame: 14 days). 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 29 Jul 2024.