Gastric CancerNCT03253107
Predicting Biomarker of Gastric Cancer Chemotherapy Response
An observational study of Gastric Cancer and Chemotherapy Effect, run by Kyungpook National University Hospital at 1 site in South Korea.
Trial summary
discovery and validation of biomarker predicting gastric cancer chemotherapy response Analysis for expression level of mRNA using Next generation sequencing in gastric cancer tissue by chemotherapy response Analysis for expression level of miRNA using Next generation sequencing in gastric cancer tissue and blood by… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Gastric Cancer, Chemotherapy Effect, Predictive Cancer Model
- What is being tested?
- Chemotherapy
- How many people
- 800 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Nov 2015to 31 Dec 2024
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: <Next generation sequencing analysis> (A) palliative chemotherapy 1. responder (n=15) 2. progression (n=15) (B) adjuvant chemotherpay 1. complete response (n=15) 2. non-responder (n=15) <qRT-PCR analysis> (Experimental set) (A) palliative chemotherapy 1. responder (n=60) 2. progression (n=60) (B) adjuvant chemotherpay 1. complete responder (n=60) 2. non-responder (n=60) (Validation set) (A) palliative chemotherapy 1. responder (n=40) 2. progression (n=40) (B) adjuvant chemotherpay 1. complete responder (n=40) 2. non-responder (n=40) 1. and 2) groups: age, sex, regimen matched. Therefore this study will be nested case-control study. We will enroll 800 patients and then we will matched age, sex, and regimen in each group.
Who may be able to join
- new gastric cancer patients who has scheduled to start 1st cycle of chemotherapy
- patients who agreed this study and voluntarily assigned the informed consents.
Who cannot join
- patients who refused the study.
- patients who have other cancers
- heavy alcoholics
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Kyungpook National University Medical Canter
Daegu, 41404
Su Youn Y Nam, MD, PhD, 82-53-200-2610, nam20131114@gmail.com
About this study
Official title: Postgenome-based Systemic Discovery of Strong Biomarkers Predict Gastric Cancer Chemotherapy Response
- discovery and validation of biomarker predicting gastric cancer chemotherapy response
- Analysis for expression level of mRNA using Next generation sequencing in gastric cancer tissue by chemotherapy response
- Analysis for expression level of miRNA using Next generation sequencing in gastric cancer tissue and blood by chemotherapy response
- Validation of mRNA and miRNA using qRT-PCR in multiple independent cohort
- Biological biomarkers-clinical factor combined prediction model of gastric cancer chemotherapy response
Read the detailed description
- discovery and validation of biomarker predicting gastric cancer chemotherapy response
- Analysis for expression level of mRNA in fresh frozen gastric cancer tissue by chemotherapy response (A) method of mRNA expression measurement: RNA sequencing (B) study group Palliative chemotherapy (inoperable patients)
- institutional primary Chemotherapy regimen (XP or Xelox)
- response group
- progression group Post-OP adjuvant chemotherapy
- institutional primary Chemotherapy regimen
- complete response group
- non-responder group <!-- -->
- and 2) groups: age, sex, regimen matched
- Analysis for expression level of miRNA using Next generation sequencing in gastric cancer tissue and blood by chemotherapy response (A) method of mRNA expression measurement: RNA sequencing (B) study group
- the same patients in mRNA sequencing
- Validation of mRNA and miRNA in multiple independent cohort method of measurement of RNA expression: qRT-PCR
- Biological biomarkers-clinical factor combined prediction model of gastric cancer chemotherapy response combination of biologic biomarker and clinical factors to predict the chemotherapy response in gastric cancer
- Conditions
- Gastric Cancer, Chemotherapy Effect, Predictive Cancer Model
- Being tested
- Chemotherapy
- Keywords
- gastric cancer, RNA sequencing, chemotherapy response, miRNA sequencing
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChemotherapyDrug
Also called XP or Xelox +/- Herceptin
Institutinal standard chemotherapy as first line
: XP (xeloda + cisplantin) or Xelox (xeloda+oxaliplitan) +/- Herceptin
| Study group | Role | What they receive |
|---|---|---|
| responder in palliative chemotherapy | After initial chemotherapy, responder (complete remission, partial remission) Receives: Drug: Chemotherapy | |
| non-responder in palliative chemotherapy | After initial chemotherapy, disease progression Receives: Drug: Chemotherapy | |
| responder in adjuvant chemotherapy | complete cure and no recurrence at least 1 year after treatment Receives: Drug: Chemotherapy | |
| non-responder in adjuvant chemotherapy | non-complete cure or recurrence within 1 year after treatment Receives: Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Discovery of predicting bio-markers for gastric cancer chemotherapy response
Discovery of predicting bio-markers for gastric cancer chemotherapy response using next generation sequencing and qRT-PCR
Measured: up to 36 months
Secondary outcomes (2)
Combination prediction model for adjuvant chemotherapy response in gastric cancer
Combination prediction model of biologic biomarkers and clinical factors for the response of adjuvant chemotherapy in gastric cancer
Measured: up to 5 years
Combination prediction model for palliative chemotherapy response in gastric cancer
Combination prediction model of biologic biomarkers and clinical factors for the response of palliative chemotherapy in gastric cancer
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2017
- Study start30 Nov 2015
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kyungpook National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Su Youn Nam, Kyungpook National University Chilgok Hospital
- Investigators
- Su Youn Nam, MD, PhD, Principal investigator, Kyungpook National University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03253107
- Sponsor's protocol ID
- KNUMC 2015-10-002-004
- Status last verified
- Oct 2023
- First submitted
- 15 Aug 2017
- Last updated
- 4 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postgenome-based Systemic Discovery of Strong Biomarkers Predict Gastric Cancer Chemotherapy Response
- ClinicalTrials.gov ID
- NCT03253107
- Acronym / sponsor ID
- KNUMC 2015-10-002-004
- Conditions
- Gastric Cancer, Chemotherapy Effect, Predictive Cancer Model
- Keywords
- gastric cancer, RNA sequencing, chemotherapy response, miRNA sequencing
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Kyungpook National University HospitalUniversity, hospital or other
- Study start
- 30 Nov 2015 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 17 Aug 2017 (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.
- discovery and validation of biomarker predicting gastric cancer chemotherapy response
- Analysis for expression level of mRNA using Next generation sequencing in gastric cancer tissue by chemotherapy response
- Analysis for expression level of miRNA using Next generation sequencing in gastric cancer tissue and blood by chemotherapy response
- Validation of mRNA and miRNA using qRT-PCR in multiple independent cohort
- Biological biomarkers-clinical factor combined prediction model of gastric cancer chemotherapy response
Detailed description
- discovery and validation of biomarker predicting gastric cancer chemotherapy response
- Analysis for expression level of mRNA in fresh frozen gastric cancer tissue by chemotherapy response (A) method of mRNA expression measurement: RNA sequencing (B) study group Palliative chemotherapy (inoperable patients)
- institutional primary Chemotherapy regimen (XP or Xelox)
- response group
- progression group Post-OP adjuvant chemotherapy
- institutional primary Chemotherapy regimen
- complete response group
- non-responder group <!-- -->
- and 2) groups: age, sex, regimen matched
- Analysis for expression level of miRNA using Next generation sequencing in gastric cancer tissue and blood by chemotherapy response (A) method of mRNA expression measurement: RNA sequencing (B) study group
- the same patients in mRNA sequencing
- Validation of mRNA and miRNA in multiple independent cohort method of measurement of RNA expression: qRT-PCR
- Biological biomarkers-clinical factor combined prediction model of gastric cancer chemotherapy response combination of biologic biomarker and clinical factors to predict the chemotherapy response in gastric cancer
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| responder in palliative chemotherapy | – | Drug: ChemotherapyAfter initial chemotherapy, responder (complete remission, partial remission) |
| non-responder in palliative chemotherapy | – | Drug: ChemotherapyAfter initial chemotherapy, disease progression |
| responder in adjuvant chemotherapy | – | Drug: Chemotherapycomplete cure and no recurrence at least 1 year after treatment |
| non-responder in adjuvant chemotherapy | – | Drug: Chemotherapynon-complete cure or recurrence within 1 year after treatment |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- <Next generation sequencing analysis> (A) palliative chemotherapy 1. responder (n=15) 2. progression (n=15) (B) adjuvant chemotherpay 1. complete response (n=15) 2. non-responder (n=15) <qRT-PCR analysis> (Experimental set) (A) palliative chemotherapy 1. responder (n=60) 2. progression (n=60) (B) adjuvant chemotherpay 1. complete responder (n=60) 2. non-responder (n=60) (Validation set) (A) palliative chemotherapy 1. responder (n=40) 2. progression (n=40) (B) adjuvant chemotherpay 1. complete responder (n=40) 2. non-responder (n=40) 1. and 2) groups: age, sex, regimen matched. Therefore this study will be nested case-control study. We will enroll 800 patients and then we will matched age, sex, and regimen in each group.
Key inclusion criteria (2 listed)
- new gastric cancer patients who has scheduled to start 1st cycle of chemotherapy
- patients who agreed this study and voluntarily assigned the informed consents.
Key exclusion criteria (3 listed)
- patients who refused the study.
- patients who have other cancers
- heavy alcoholics
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 |
|---|---|---|
| ChemotherapyAlso: XP or Xelox +/- HerceptinInstitutinal standard chemotherapy as first line : XP (xeloda + cisplantin) or Xelox (xeloda+oxaliplitan) +/- Herceptin | Drug | non-responder in adjuvant chemotherapy, non-responder in palliative chemotherapy, responder in adjuvant chemotherapy, responder in palliative chemotherapy |
Primary outcome
Discovery of predicting bio-markers for gastric cancer chemotherapy response
Time frame: up to 36 months
Discovery of predicting bio-markers for gastric cancer chemotherapy response using next generation sequencing and qRT-PCR
2 secondary outcomes
Combination prediction model for adjuvant chemotherapy response in gastric cancer
Time frame: up to 5 years
Combination prediction model for palliative chemotherapy response in gastric cancer
Time frame: up to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2023.
- 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.
Su Youn Nam, MD, PhD principal investigator
Kyungpook National University 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 Gastric Cancer and Chemotherapy Effect, run by Kyungpook National University Hospital 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 2 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: status not confirmed, as of the sponsor's last update on 4 Oct 2023. 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?
Contact Su Youn Nam, MD, PhD (82-53-200-2610, nam20131114@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Discovery of predicting bio-markers for gastric cancer chemotherapy response (time frame: up to 36 months). 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 4 Oct 2023.