Gastric CancerSPRINTNCT04600518
Single Patient Classifier (SPC) Prediction for Stage II and III Advanced Gastric Cancer
An observational study of Gastric Cancer, run by Novomics. Co., Ltd. at 1 site in South Korea.
Trial summary
A retrospective, multi-center, single-blind, pivotal trial to assess clinical equivalence with stage II and III advanced gastric cancer based on the 6th and 8th of the AJCC 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
- 2,047 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Oct 2020to 22 Jun 2023
- 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: 19 years or older patients with stage II, III gastric adenocarcinoma
Who may be able to join
- Sample providers criteria
- Male and female adult patients aged 19 years or over
- Postoperative patients with gastric cancer invading the submucosal layer and having 3 or more lymph nodes metastasis or who with gastric cancer infiltration of muscularis propria and lymph node metastasis (stage II and III advanced gastric cancer patients, 8th of the AJCC)
- Patients who have not received neoadjuvant chemotherapy and radiotherapy
- Patients with pathological record and clinical information after surgery from archived FFPE(formalin-fixed paraffin-embedded) samples between 2005 and 2010
- Patients who have not been included in discovery clinical trial and confirmatory clinical trial
Show all 10Show fewer
- Patients who have undergone a radical gastrectomy and who show no evidence of residual tumors as observed with the unaided eye or through a microscope
- Sample criteria
- The FFPE tumor specimens in storage have a tumor amount of at least 20% and therefore can be tested.
- The quantity (not less than 400ng) and quality (A260/280 of not less than 1.8) of RNA are sufficient for analysis.
Who cannot join
- Sample providers criteria
- Male and female patients aged less than 19 years
- Postoperative patients with gastric cancer invading the mucosa and submucosal layer and having less than 3 lymph nodes metastasis or who with gastric cancer infiltration of muscularis propria without lymph node metastasis (stage II and III advanced gastric cancer patients, 8th of the AJCC)
- Patients who have received neoadjuvant chemotherapy or radiotherapy
- Patients without pathological record and clinical information after surgery from archived FFPE samples between 2005 and 2010
- Patients who have been included in discovery clinical trial and confirmatory clinical trial
Show all 10Show fewer
- Patients with residual tumors after surgery
- Sample criteria
- The FFPE tumor specimens in storage have a tumor amount of less than 20% and therefore cannot be tested
- The quantity and quality of RNA are not sufficient for analysis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Retrospective, Multi-center, Single-blind, Pivotal Trial to Assess Clinical Equivalence With Stage II and III Advanced Gastric Cancer Based on the 6th and 8th of the AJCC
A retrospective, multi-center, single-blind, pivotal trial to assess clinical equivalence with stage II and III advanced gastric cancer based on the 6th and 8th of the AJCC
Read the detailed description
The safety and effectiveness of nProfiler® 1 Stomach Cancer Assay have been evaluated with stage II and III advanced gastric cancer patients based on the 6th of the American Joint Committee on Cancer (AJCC) through discovery clinical trial (418 patients) and confirmatory clinical trial (684 patients).
The goal of this study, a retrospective, multi-center, single-blind, pivotal trial, is to assess clinical equivalence with stage II and III advanced gastric cancer based on the 6th and 8th of the AJCC and to evaluate prognostic equivalence between surgery only group and adjuvant chemotherapy group in Low risk group.
The study will follow these procedures; Sample screening, Sample Preparation and Sample Criteria Evaluation, Sample enrollment, nProfiler® 1 Stomach Cancer Assay (gastric cancer prognosis prediction), Prognostic Result Report, and Evaluation of Clinical Performance.
- 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 |
|---|---|---|
| SPRINT cohort | stage II and III advanced gastric cancer patients based on the 6th and 8th of the AJCC 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.
Differences in prognosis
Differences in prognosis between Low risk group and High risk group (AJCC 8th, Advanced gastric cancer stage II and III)
Measured: 5 years after the date of surgery for patients in Low risk group and High risk group
Comparability of prognostic stratification
Comparability of prognostic stratification with stage II and III advanced gastric cancer based on the 6th and 8th of the AJCC
Measured: 5 years after the date of surgery for patients in Low risk group and High risk group
Prognostic equivalence
Prognostic equivalence between surgery only group and adjuvant chemotherapy group in Low risk group
Measured: 5 years after the date of surgery for patients in surgery only group and adjuvant chemotherapy group in Low risk group
Secondary outcomes (1)
Multivariate analysis
Multivariate analysis with age, sex, TNM stage, adjuvant-chemotherapy
Measured: 5 years after the date of surgery for patients with stage II-III advanced gastric cancer (8th of the AJCC)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2020
- Study start7 Oct 2020
- Primary completion18 Jun 2023
- Study completion22 Jun 2023
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
- Retrospective
- Enrolment
- 2,047 participants (actual)
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
- NCT04600518
- Sponsor's protocol ID
- NM-CTP-04
- Acronym
- SPRINT
- Status last verified
- Jul 2023
- First submitted
- 19 Oct 2020
- Last updated
- 22 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective, Multi-center, Single-blind, Pivotal Trial to Assess Clinical Equivalence With Stage II and III Advanced Gastric Cancer Based on the 6th and 8th of the AJCC
- ClinicalTrials.gov ID
- NCT04600518
- Acronym / sponsor ID
- SPRINT / NM-CTP-04
- Conditions
- Gastric Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,047 participants (actual)
- Lead sponsor
- Novomics. Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Oct 2020 (actual)
- Primary completion
- 18 Jun 2023 (actual)
- Study completion
- 22 Jun 2023 (actual)
- First posted
- 23 Oct 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.
A retrospective, multi-center, single-blind, pivotal trial to assess clinical equivalence with stage II and III advanced gastric cancer based on the 6th and 8th of the AJCC
Detailed description
The safety and effectiveness of nProfiler® 1 Stomach Cancer Assay have been evaluated with stage II and III advanced gastric cancer patients based on the 6th of the American Joint Committee on Cancer (AJCC) through discovery clinical trial (418 patients) and confirmatory clinical trial (684 patients).
The goal of this study, a retrospective, multi-center, single-blind, pivotal trial, is to assess clinical equivalence with stage II and III advanced gastric cancer based on the 6th and 8th of the AJCC and to evaluate prognostic equivalence between surgery only group and adjuvant chemotherapy group in Low risk group.
The study will follow these procedures; Sample screening, Sample Preparation and Sample Criteria Evaluation, Sample enrollment, nProfiler® 1 Stomach Cancer Assay (gastric cancer prognosis prediction), Prognostic Result Report, and Evaluation of Clinical Performance.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SPRINT cohort | – | Device: nProfiler I Stomach Cancer Assay Kitstage II and III advanced gastric cancer patients based on the 6th and 8th of the AJCC |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 19 years or older patients with stage II, III gastric adenocarcinoma
Key inclusion criteria (10 listed)
- Sample providers criteria
- Sample criteria
Key exclusion criteria (10 listed)
- Sample providers criteria
- Sample criteria
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 | SPRINT cohort |
Primary outcome
Differences in prognosis
Time frame: 5 years after the date of surgery for patients in Low risk group and High risk group
Differences in prognosis between Low risk group and High risk group (AJCC 8th, Advanced gastric cancer stage II and III)
Comparability of prognostic stratification
Time frame: 5 years after the date of surgery for patients in Low risk group and High risk group
Comparability of prognostic stratification with stage II and III advanced gastric cancer based on the 6th and 8th of the AJCC
Prognostic equivalence
Time frame: 5 years after the date of surgery for patients in surgery only group and adjuvant chemotherapy group in Low risk group
Prognostic equivalence between surgery only group and adjuvant chemotherapy group in Low risk group
1 secondary outcome
Multivariate analysis
Time frame: 5 years after the date of surgery for patients with stage II-III advanced gastric cancer (8th of the AJCC)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2024.
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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 10 inclusion and 10 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: finished, as of the sponsor's last update on 22 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Differences in prognosis (time frame: 5 years after the date of surgery for patients in Low risk group and High risk group). The study lists 3 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 22 Jul 2024.