Gastric CancerNCT02852096
Assessing Her2/Neu Expression in Gastric Cancer With Dual or Multiple Tumor Tissue Paraffin Blocks
A study testing Dual or Multiple Paraffin Blocks and One Paraffin Blocks in people with Gastric Cancer and HER-2, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
One paraffin block is routinely used for Human Epidermal Growth Factor Receptor 2 (Her2/neu) immunohistochemistry (IHC) assessment. Here, investigators investigated if picking two or multiple paraffin blocks for Her2/neu evaluation is an economical, efficient and practical method, which may reduce false-negativity of… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastric Cancer, HER-2
- What is being tested?
- Dual or Multiple Paraffin Blocks and One Paraffin Blocks
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- Nov 2015to Dec 2019
- Phase
- Interventional
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 to 80; Received curative surgery with primary gastric adenocarcinoma; Did not receive any preoperative treatment.
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
Yingyong Hou, M.D. & Ph.D. contact
China1 site, 1 recruiting
- Recruiting
180 Fenglin Road
Shanghai, Shanghai Municipality, 200032
Yingyong Hou, M.D.& Ph.D., 86-13681972385, hou.yingyong@zs-hospital.sh.cn
Yingyong Hou, Professor
About this study
One paraffin block is routinely used for Human Epidermal Growth Factor Receptor 2 (Her2/neu) immunohistochemistry (IHC) assessment. Here, investigators investigated if picking two or multiple paraffin blocks for Her2/neu evaluation is an economical, efficient and practical method, which may reduce false-negativity of Her2/neu IHC assessment due to intratumoral heterogeneity.
- Conditions
- Gastric Cancer, HER-2
- Being tested
- Dual or Multiple Paraffin Blocks, One Paraffin Blocks
- Keywords
- gastric cancer, Her2/neu, dual paraffin blocks, trastuzumab
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual or Multiple Paraffin BlocksOther
Assessing Her2/Neu Expression in Gastric Cancer With Dual or Multiple Tumor Tissue Paraffin Blocks
One Paraffin BlocksOther
Assessing Her2/Neu Expression in Gastric Cancer With One Tumor Tissue Paraffin Blocks
| Study group | Role | What they receive |
|---|---|---|
| Dual or Multiple Paraffin Blocks | Experimental | Assessing Her2/neu Expression in Gastric Cancer with Dual or Multiple Tumor Tissue Paraffin Blocks Receives: Other: Dual or Multiple Paraffin Blocks |
| One Paraffin Blocks | Active comparator | Assessing Her2/neu Expression in Gastric Cancer with One Tumor Tissue Paraffin Blocks Receives: Other: One Paraffin Blocks |
What is being measured
The primary outcome is the main question the study is designed to answer.
The positive rate of cohort using dual or multiple tumor tissue paraffin blocks
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2016 (estimated)
- Study startNov 2015
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yingyong Hou, M.D. & Ph.D., Study chair, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02852096
- Sponsor's protocol ID
- B2015-055R
- Status last verified
- Nov 2017
- First submitted
- 8 Nov 2015
- Last updated
- 13 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bang YJ, Van Cutsem E, Feyereislova A, Chung HC, Shen L, Sawaki A, Lordick F, Ohtsu A, Omuro Y, Satoh T, Aprile G, Kulikov E, Hill J, Lehle M, Ruschoff J, Kang YK; ToGA Trial Investigators. Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial. Lancet. 2010 Aug 28;376(9742):687-97. doi: 10.1016/S0140-6736(10)61121-X. Epub 2010 Aug 19.
PubMed 20728210
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Her2/Neu Expression in Gastric Cancer With Dual or Multiple Tumor Tissue Paraffin Blocks
- ClinicalTrials.gov ID
- NCT02852096
- Acronym / sponsor ID
- B2015-055R
- Conditions
- Gastric Cancer, HER-2
- Keywords
- gastric cancer, Her2/neu, dual paraffin blocks, trastuzumab
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 2 Aug 2016 (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.
One paraffin block is routinely used for Human Epidermal Growth Factor Receptor 2 (Her2/neu) immunohistochemistry (IHC) assessment. Here, investigators investigated if picking two or multiple paraffin blocks for Her2/neu evaluation is an economical, efficient and practical method, which may reduce false-negativity of Her2/neu IHC assessment due to intratumoral heterogeneity.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dual or Multiple Paraffin Blocks | Experimental | Other: Dual or Multiple Paraffin BlocksAssessing Her2/neu Expression in Gastric Cancer with Dual or Multiple Tumor Tissue Paraffin Blocks |
| One Paraffin Blocks | Active comparator | Other: One Paraffin BlocksAssessing Her2/neu Expression in Gastric Cancer with One Tumor Tissue Paraffin Blocks |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age between 18 to 80; Received curative surgery with primary gastric adenocarcinoma; Did not receive any preoperative treatment.
Key exclusion criteria (1 listed)
- None.
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 |
|---|---|---|
| Dual or Multiple Paraffin BlocksAssessing Her2/Neu Expression in Gastric Cancer With Dual or Multiple Tumor Tissue Paraffin Blocks | Other | Dual or Multiple Paraffin Blocks |
| One Paraffin BlocksAssessing Her2/Neu Expression in Gastric Cancer With One Tumor Tissue Paraffin Blocks | Other | One Paraffin Blocks |
Primary outcome
The positive rate of cohort using dual or multiple tumor tissue paraffin blocks
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2017.
- Results publication: PubMed 20728210Bang YJ, Van Cutsem E, Feyereislova A, Chung HC, Shen L, Sawaki A, Lordick F, Ohtsu A, Omuro Y, Satoh T, Aprile G, Kulikov E, Hill J, Lehle M, Ruschoff J, Kang YK; ToGA Trial Investigators. Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial. Lancet. 2010 Aug 28;376(9742):687-97. doi: 10.1016/S0140-6736(10)61121-X. Epub 2010 Aug 19.
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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.
Yingyong Hou, M.D. & Ph.D. contact
Yingyong Hou, M.D. & Ph.D. study chair
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dual or Multiple Paraffin Blocks and One Paraffin Blocks in people with Gastric Cancer and HER-2, run by Shanghai Zhongshan Hospital at 1 site in China.
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 1 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 Nov 2017. 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 China. 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 Yingyong Hou, M.D. & Ph.D. (hou.yingyong@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The positive rate of cohort using dual or multiple tumor tissue paraffin blocks (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02852096, which also lists 1 linked publication.
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 Nov 2017.