Gastric CancerPREDICTNCT04487717
Prospective Assessment of nProfiler® 1 on Prognosis and Chemotherapy Response for Gastric Cancer
An observational study of Gastric Cancer, run by Novomics. Co., Ltd. at 1 site in South Korea.
Trial summary
Prospective assessment of nProfiler® 1 predictive test on prognosis and chemotherapy response for resectable gastric cancer 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
- 581 participants
- Where
- 1 siteSouth Korea
- Study dates
- 29 Jul 2020to 31 Dec 2029
- 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 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
- Patients with histologically confirmed gastric adenocarcinoma
- Patients with histologically confirmed stage Ⅱ or Ⅲ
- Patients who have undergone radical gastrectomy
- Patients who have not received neoadjuvant chemotherapy and radiotherapy
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- 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
- Patients who have signed a written consent of the study and signed a human derived research agreement (Form 34)
- Sample criteria
- The formalin-fixed paraffin-embedded (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
- Patients with histologically not confirmed gastric adenocarcinoma
- Patients with histologically confirmed stage Ⅰ or Ⅳ
- Patients who have not undergone radical gastrectomy
- Patients who have received neoadjuvant chemotherapy or radiotherapy
Show all 11Show fewer
- Patients with distant or peritoneal metastasis at the time of surgery or residual tumors after surgery
- Patients who have not signed the study's written consent and human derived research agreement (Form 34)
- 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
Prospective assessment of nProfiler® 1 predictive test on prognosis and chemotherapy response for resectable gastric cancer
Read the detailed description
- Background: According to Global Cancer Statistics of International Agency for Research on Cancer under World Health Organization, stomach cancer is the fifth most common cancer as there were over 1 million new cases in 2018 and the third leading cause of cancer death by 783,000 people are estimated to die of stomach cancer. In Korea, gastric cancer is the most frequent cancer in 13.3% of all cancer cases by the report of Korea Central Cancer Registry in 2018. Since 2010, adjuvant chemotherapy with advanced gastric cancer stage 2 and stage 3 patients following gastrectomy has become a standard treatment through clinical validation of increasing the patient's survival rate. However, even in the second and third stages of the same stomach cancer, the biological properties may be different.
- Purpose: The nProfiler® 1 Stomach Cancer Assay is a molecular diagnostic test to predict the prognosis for patients with stage Ⅱ-Ⅲ advanced gastric cancer. This study will evaluate the clinical utility of nProfiler® 1 Stomach Cancer Assay by recruiting subjects from multi centers and observing the 5-year survival rates of Low risk, Intermediate risk, High risk according to gastric cancer prognostic molecular diagnostic test.
- Study Procedure:
- Obtaining of informed consent form
- Review of provider's eligibility/ Sample preparation and delivery
- Sample criteria evaluation
- Subject enrollment
- Gastric cancer prognostic prediction molecular diagnostic test
- Prognostic group result report
- 5-yr survival follow-up
- Statistical analysis
- Outcome Measures:
The following efficacy outcome measures will be assessed:
- Primary efficacy outcome measure :High risk and low risk group's 5-yr Overall Survival(OS) rate
- Secondary efficacy outcome measure
- High risk and Low risk group's 3-yr Disease Free Survival(DFS) rate
- Intermediate risk group's 5-yr OS and 3-yr DFS rate
- Subgroup analysis : Adjuvant chemotherapy benefit of Low risk (5-yr OS rate, 3 yr DFS rate)
- 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 |
|---|---|---|
| PREDICT cohort | Patients with pathologic stage II, III advanced gastric cancer 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.
Prognostic group's 5-yr Overall Survival(OS) rate
High risk and low risk group's 5-yr Overall Survival(OS) rate
Measured: 5 years after last registered patient
Secondary outcomes (2)
Prognostic group's 3-yr Disease Free Survival(DFS) rate
High risk and Low risk group's 3-yr Disease Free Survival(DFS) rate Intermediate risk group's 5-yr Os and 3-yr DFS rate
Measured: 3 years after last registered patient
Subgroup analysis
Adjuvant chemotherapy benefit of Low risk (5-yr OS rate, 3 yr DFS rate)
Measured: 3, 5 years after last registered patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2020
- Study start29 Jul 2020
- Primary completion31 Oct 2029 (estimated)
- Study completion31 Dec 2029 (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
- 581 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
- NCT04487717
- Sponsor's protocol ID
- NM-CTP-05
- Acronym
- PREDICT
- Status last verified
- Dec 2024
- First submitted
- 22 Jul 2020
- Last updated
- 17 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Assessment of nProfiler® 1 on Prognosis and Chemotherapy Response for Gastric Cancer
- ClinicalTrials.gov ID
- NCT04487717
- Acronym / sponsor ID
- PREDICT / NM-CTP-05
- Conditions
- Gastric Cancer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 581 participants (actual)
- Lead sponsor
- Novomics. Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 Jul 2020 (actual)
- Primary completion
- 31 Oct 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 27 Jul 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.
Prospective assessment of nProfiler® 1 predictive test on prognosis and chemotherapy response for resectable gastric cancer
Detailed description
- Background: According to Global Cancer Statistics of International Agency for Research on Cancer under World Health Organization, stomach cancer is the fifth most common cancer as there were over 1 million new cases in 2018 and the third leading cause of cancer death by 783,000 people are estimated to die of stomach cancer. In Korea, gastric cancer is the most frequent cancer in 13.3% of all cancer cases by the report of Korea Central Cancer Registry in 2018. Since 2010, adjuvant chemotherapy with advanced gastric cancer stage 2 and stage 3 patients following gastrectomy has become a standard treatment through clinical validation of increasing the patient's survival rate. However, even in the second and third stages of the same stomach cancer, the biological properties may be different.
- Purpose: The nProfiler® 1 Stomach Cancer Assay is a molecular diagnostic test to predict the prognosis for patients with stage Ⅱ-Ⅲ advanced gastric cancer. This study will evaluate the clinical utility of nProfiler® 1 Stomach Cancer Assay by recruiting subjects from multi centers and observing the 5-year survival rates of Low risk, Intermediate risk, High risk according to gastric cancer prognostic molecular diagnostic test.
- Study Procedure:
- Obtaining of informed consent form
- Review of provider's eligibility/ Sample preparation and delivery
- Sample criteria evaluation
- Subject enrollment
- Gastric cancer prognostic prediction molecular diagnostic test
- Prognostic group result report
- 5-yr survival follow-up
- Statistical analysis
- Outcome Measures:
The following efficacy outcome measures will be assessed:
- Primary efficacy outcome measure :High risk and low risk group's 5-yr Overall Survival(OS) rate
- Secondary efficacy outcome measure
- High risk and Low risk group's 3-yr Disease Free Survival(DFS) rate
- Intermediate risk group's 5-yr OS and 3-yr DFS rate
- Subgroup analysis : Adjuvant chemotherapy benefit of Low risk (5-yr OS rate, 3 yr DFS rate)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PREDICT cohort | – | Device: nProfiler I Stomach Cancer Assay KitPatients with pathologic stage II, III advanced gastric cancer |
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 (11 listed)
- Sample providers criteria
- Sample criteria
Key exclusion criteria (11 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 | PREDICT cohort |
Primary outcome
Prognostic group's 5-yr Overall Survival(OS) rate
Time frame: 5 years after last registered patient
High risk and low risk group's 5-yr Overall Survival(OS) rate
2 secondary outcomes
Prognostic group's 3-yr Disease Free Survival(DFS) rate
Time frame: 3 years after last registered patient
Subgroup analysis
Time frame: 3, 5 years after last registered patient
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 17 Dec 2024.
- Individual participant dataSharing planned: No
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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 11 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 17 Dec 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?
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?
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?
Prognostic group's 5-yr Overall Survival(OS) rate (time frame: 5 years after last registered patient). 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 17 Dec 2024.