Stomach NeoplasmsHER2NCT02136836
Investigation of the Proportion of Human Epidermal Growth Factor Receptor 2 Protein Overexpression of Gastric Adenocarcinoma and Prognostic Effect of HER2, and Analysis of Practice Pattern of Herceptin Use in Stage IV Gastric Cancer
An observational study of Stomach Neoplasms, run by Yonsei University at 1 site in South Korea.
Trial summary
The objective of this study is to investigate the proportion of HER2 overexpression in gastric cancer patients group, to evaluate the relation of HER2 overexpression with prognosis, and to analyze the proportion of herceptin applied to patients in clinical field. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stomach Neoplasms
- How many people
- 860 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2014to Mar 2015
- 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: gastric cancer patients in Gangnam Severance Hospital
Who may be able to join
- Histologically confirmed gastric adenocarcinoma
- Patients were diagnosed during 2006-2013
- HER2 expression status was evaluated in primary gastric cancer or metastatic lesion.
Who cannot join
- Patients with second primary cancer within 5 years
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study is to investigate the proportion of HER2 overexpression in gastric cancer patients group, to evaluate the relation of HER2 overexpression with prognosis, and to analyze the proportion of herceptin applied to patients in clinical field. Furthermore, the investigators are going to reevaluate the clinical benefit of Herceptin for survival prolongation compared to chemotherapy only.
- Conditions
- Stomach Neoplasms
- Keywords
- Genes, erbB-2, Prognosis
- 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 |
|---|---|---|
| gastric adenocarcinoma | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of HER2 overexpression in gastric cancer patients
Measured: 8 years
Secondary outcomes (1)
Gastric cancer specific survival according to HER2 expression in each stage
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2014 (estimated)
- Study startMay 2014
- Primary completionMar 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stomach NeoplasmsStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 860 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jae Yong Cho, Yonsei University
- Investigators
- Jae Yong Cho, M.D.,Ph.D., Principal investigator, Gangnam Severance Hospital, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02136836
- Sponsor's protocol ID
- GSCH-STO13-01
- Other IDs
- Roche
- Acronym
- HER2
- Status last verified
- Apr 2014
- First submitted
- 8 May 2014
- Last updated
- 13 May 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Proportion of Human Epidermal Growth Factor Receptor 2 Protein Overexpression of Gastric Adenocarcinoma and Prognostic Effect of HER2, and Analysis of Practice Pattern of Herceptin Use in Stage IV Gastric Cancer
- ClinicalTrials.gov ID
- NCT02136836
- Acronym / sponsor ID
- HER2 / GSCH-STO13-01
- Conditions
- Stomach Neoplasms
- Keywords
- Genes, erbB-2, Prognosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 860 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Mar 2015 (estimated)
- First posted
- 13 May 2014 (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.
The objective of this study is to investigate the proportion of HER2 overexpression in gastric cancer patients group, to evaluate the relation of HER2 overexpression with prognosis, and to analyze the proportion of herceptin applied to patients in clinical field. Furthermore, the investigators are going to reevaluate the clinical benefit of Herceptin for survival prolongation compared to chemotherapy only.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| gastric adenocarcinoma | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- gastric cancer patients in Gangnam Severance Hospital
Key inclusion criteria (3 listed)
- Histologically confirmed gastric adenocarcinoma
- Patients were diagnosed during 2006-2013
- HER2 expression status was evaluated in primary gastric cancer or metastatic lesion.
Key exclusion criteria (1 listed)
- Patients with second primary cancer within 5 years
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
The proportion of HER2 overexpression in gastric cancer patients
Time frame: 8 years
1 secondary outcome
Gastric cancer specific survival according to HER2 expression in each stage
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2014.
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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.
Jae Yong Cho, M.D.,Ph.D. principal investigator
Gangnam Severance Hospital, Yonsei University
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 Stomach Neoplasms, run by Yonsei University 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 3 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 13 May 2014. 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?
The proportion of HER2 overexpression in gastric cancer patients (time frame: 8 years). 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 13 May 2014.