Gastric CancerNCT02538562
Human Epidermal Growth Factor Receptor 2 (HER2) Advanced Gastric Epidemiology Study in Korea
An observational study of Gastric Cancer and Gastroesophageal Junction Cancer, run by Hoffmann-La Roche at 14 sites in South Korea.
Trial summary
This study is designed to gather epidemiological data in Korea on HER2 incidence in gastric and gastroesophageal junction cancer as assessed by local laboratories in a real-life setting. No investigational products will be provided or evaluated. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gastric Cancer, Gastroesophageal Junction Cancer
- How many people
- 1,695 participants
- Where
- 14 sitesSouth Korea
- Study dates
- 11 Oct 2011to 19 Apr 2013
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Available tumor samples from patients with gastric or gastroesophageal junction cancer will be analyzed. No study visits or interventions are planned.
Who may be able to join
- Formalin-fixed, paraffin-embedded tumor tissue samples with histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction with locally advanced, recurrent, and/or metastatic disease
- Sufficient invasive tumor tissue for HER2 evaluation, including surgical excision specimens or at least 6 to 8 available biopsies
Who cannot join
- None specified
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
South Korea14 sites
Dongnam Inst.of Radiological & Medical Sciences
Busan, 46033
Inje University Busan Paik Hospital
Busan, 47392
Inje university Haeundae Paik Hospital
Busan, 48108
Kosin University Gospel Hospital
Busan, 49267
Pusan University Hospital
Busan, 602-739
Samsung Changwon Hospital
Changwon
Dankook University Hospital
Chungcheongnam-do, 31116
Keimyung University Dongsan Medical Center
Daegu, 41931
Daegu Catholic University Medical Center
Daegu, 42472
Yeungnam Univ. Hospital
Daegu, 705-717
Chosun University Hospital
Gwangju, 61453
Pusan National University Yangsan Hospital
Gyeongsangnam-do, 50612
Gyeongsang National University Hospital
Gyeongsangnam-do, 52727
Chonbuk National Uni Hospital
Jeollabuk-do, 561-712
About this study
Official title: HER2 Advanced Gastric Epidemiology Study in Korea: An Assessment of HER2 Status in Tumor Tissue Samples of Gastric and Gastro-esophageal (GE) Junction Cancer
This study is designed to gather epidemiological data in Korea on HER2 incidence in gastric and gastroesophageal junction cancer as assessed by local laboratories in a real-life setting. No investigational products will be provided or evaluated.
- Conditions
- Gastric Cancer, Gastroesophageal Junction Cancer
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study Population | Available tumor samples from patients with gastric or gastroesophageal junction cancer will be analyzed. No study visits or interventions are planned. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of HER2 positivity among gastric and gastroesophageal junction tumor samples
Measured: Up to 12 months of sample collection
Secondary outcomes (5)
Correlation between HER2 status and tumor stage
Measured: Up to 12 months of sample collection
Correlation between HER2 status and tumor type
Measured: Up to 12 months of sample collection
Correlation between HER2 status and cancer diagnosis
Measured: Up to 12 months of sample collection
Correlation between HER2 status and age
Measured: Up to 12 months of sample collection
Correlation between HER2 status and gender
Measured: Up to 12 months of sample collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2015 (estimated)
- Study start11 Oct 2011
- Primary completion19 Apr 2013
- Study completion19 Apr 2013
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.
- More trials run by Hoffmann-La RocheThe 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
- 1,695 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02538562
- Sponsor's protocol ID
- ML25697
- Status last verified
- Jul 2017
- First submitted
- 31 Aug 2015
- Last updated
- 11 Jul 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HER2 Advanced Gastric Epidemiology Study in Korea: An Assessment of HER2 Status in Tumor Tissue Samples of Gastric and Gastro-esophageal (GE) Junction Cancer
- ClinicalTrials.gov ID
- NCT02538562
- Acronym / sponsor ID
- ML25697
- Conditions
- Gastric Cancer, Gastroesophageal Junction Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,695 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 11 Oct 2011 (actual)
- Primary completion
- 19 Apr 2013 (actual)
- Study completion
- 19 Apr 2013 (actual)
- First posted
- 2 Sep 2015 (estimated)
- 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.
This study is designed to gather epidemiological data in Korea on HER2 incidence in gastric and gastroesophageal junction cancer as assessed by local laboratories in a real-life setting. No investigational products will be provided or evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Population | – | –Available tumor samples from patients with gastric or gastroesophageal junction cancer will be analyzed. No study visits or interventions are planned. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Available tumor samples from patients with gastric or gastroesophageal junction cancer will be analyzed. No study visits or interventions are planned.
Key inclusion criteria (2 listed)
- Formalin-fixed, paraffin-embedded tumor tissue samples with histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction with locally advanced, recurrent, and/or metastatic disease
- Sufficient invasive tumor tissue for HER2 evaluation, including surgical excision specimens or at least 6 to 8 available biopsies
Key exclusion criteria (1 listed)
- None specified
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
Incidence of HER2 positivity among gastric and gastroesophageal junction tumor samples
Time frame: Up to 12 months of sample collection
5 secondary outcomes
Correlation between HER2 status and tumor stage
Time frame: Up to 12 months of sample collection
Correlation between HER2 status and tumor type
Time frame: Up to 12 months of sample collection
Correlation between HER2 status and cancer diagnosis
Time frame: Up to 12 months of sample collection
Correlation between HER2 status and age
Time frame: Up to 12 months of sample collection
Correlation between HER2 status and gender
Time frame: Up to 12 months of sample collection
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 11 Jul 2017.
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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.
Clinical Trials study director
Hoffmann-La Roche
14 sites 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 Gastroesophageal Junction Cancer, run by Hoffmann-La Roche at 14 sites 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 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: finished, as of the sponsor's last update on 11 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites 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?
Incidence of HER2 positivity among gastric and gastroesophageal junction tumor samples (time frame: Up to 12 months of sample collection). 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 11 Jul 2017.