Gastric CancerNCT01814345
Her 2 Testing in Indian Patients With Gastric Cancer
An observational study of Gastric Cancer, run by Tata Memorial Hospital at 1 site in India.
Trial summary
Gastric cancer remains a major health issue and a leading cause of cancer death worldwide, although the prevalence and mortality of the disease have gradually decreased. The investigators have very few options for patients with advanced disease. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Gastric Cancer
- How many people
- 100 participants
- Where
- 1 siteIndia
- Study dates
- Jun 2013to Feb 2017
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 100 consecutive Gastric Cancer
Who may be able to join
- 100 consecutive patients with gastric cancer who have a pathology specimen at TMH
Who cannot join
- If histopathology blocks were not available
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "An Observational Study to Determine the Incidence of of Her 2 Positivity in 100 Consecutive Gastric Cancers"
Gastric cancer remains a major health issue and a leading cause of cancer death worldwide, although the prevalence and mortality of the disease have gradually decreased. The investigators have very few options for patients with advanced disease.
The trastuzumab for Gastric Cancer (ToGA) trial, a pivotal randomized clinical trial of patients with HER-2 positive advanced, mostly metastatic, gastric cancer, proved the efficacy of trastuzumab (anti-Her 2 therapy) in combination with chemotherapy. The median overall survival was significantly prolonged in the trastuzumab-containing arm (13.8 vs. 11.1 months; HR 0.74; p=0.0046) without unexpected toxicity including cardiac events. The survival benefit was most pronounced in the subgroup of high HER-2/neu protein overexpression (median overall survival of 16 months). Only 20% of the patients screened and subsequently enrolled for this study were found to be HER2-positive when utilizing both immunohistochemistry and FISH. Her2 testing is recommended for all patients with advanced gastric cancers and type III oesophageal adenocarcinomas.
Data on Indian patients is lacking. Hence, the investigators plan to test for Her 2 in 100 patients with IHC and FISH in 2+ and 3+ patients.
Read the detailed description
- Study Objective/ Aims Aim: - Rate of Her 2 positivity in 100 consecutive gastric cancer patients Primary Objective Test for Her 2 in 100 consecutive gastric cancer patients Immuno-histochemistry will be done in all patients. Patients with 2 and 3+ IHC will also have FISH done.
- Study Design\& Methodology Patients will have the Her2 tested in 100 consecutive gastric cancer samples by immunohistochemistry and patients with 2+ and 3+ result will also have FISH done. This will not affect patient management
- Overview of Data collection Dr.Bhawna Sirohi the principal investigators will maintain and supervise data collection and maintaining records. The patient will be de-identified.
- Selection of Study Population
Inclusion Criteria:
100 consecutive patients with gastric cancer who have a pathology specimen at TMH
Exclusion Criteria:
If histopathology blocks were not available
- Sample size 100 to be enrolled. Patient consent waiver applied for as this does not affect patient care 6) Statistical Analysis It is an Observational study so Results will be given as %age of total population.
- Conditions
- Gastric Cancer
- Keywords
- Her2 testing (Human Epidermal Growth Factor Receptor 2)
- Medical subject headings
- Stomach Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Her2 testing in Gastric cancer
Immuno-histochemistry will be done in all patients. Patients with 2 and 3+ IHC will also have FISH done.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2013 (estimated)
- Study startJun 2013
- Primary completionFeb 2017
- Study completionFeb 2017
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
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tata Memorial Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr Bhawna Sirohi, Tata Memorial Hospital
- Investigators
- Dr Bhawna Sirohi, MBBS DCH, Principal investigator, Consulting Medical OncologistShailesh Shrikhande, MS, Principal investigator, Professor of Surgical GI and HPB surgeryMukta Ramadwar, MD, Principal investigator, Consultant Pathologist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01814345
- Sponsor's protocol ID
- 1077
- Other IDs
- Her 2 in gastric cancer
- Status last verified
- Apr 2017
- First submitted
- 27 Feb 2013
- Last updated
- 27 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "An Observational Study to Determine the Incidence of of Her 2 Positivity in 100 Consecutive Gastric Cancers"
- ClinicalTrials.gov ID
- NCT01814345
- Acronym / sponsor ID
- 1077
- Conditions
- Gastric Cancer
- Keywords
- Her2 testing (Human Epidermal Growth Factor Receptor 2)
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Tata Memorial HospitalOther government
- Study start
- Jun 2013 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 19 Mar 2013 (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.
Gastric cancer remains a major health issue and a leading cause of cancer death worldwide, although the prevalence and mortality of the disease have gradually decreased. The investigators have very few options for patients with advanced disease.
The trastuzumab for Gastric Cancer (ToGA) trial, a pivotal randomized clinical trial of patients with HER-2 positive advanced, mostly metastatic, gastric cancer, proved the efficacy of trastuzumab (anti-Her 2 therapy) in combination with chemotherapy. The median overall survival was significantly prolonged in the trastuzumab-containing arm (13.8 vs. 11.1 months; HR 0.74; p=0.0046) without unexpected toxicity including cardiac events. The survival benefit was most pronounced in the subgroup of high HER-2/neu protein overexpression (median overall survival of 16 months). Only 20% of the patients screened and subsequently enrolled for this study were found to be HER2-positive when utilizing both immunohistochemistry and FISH. Her2 testing is recommended for all patients with advanced gastric cancers and type III oesophageal adenocarcinomas.
Data on Indian patients is lacking. Hence, the investigators plan to test for Her 2 in 100 patients with IHC and FISH in 2+ and 3+ patients.
Detailed description
- Study Objective/ Aims Aim: - Rate of Her 2 positivity in 100 consecutive gastric cancer patients Primary Objective Test for Her 2 in 100 consecutive gastric cancer patients Immuno-histochemistry will be done in all patients. Patients with 2 and 3+ IHC will also have FISH done.
- Study Design\& Methodology Patients will have the Her2 tested in 100 consecutive gastric cancer samples by immunohistochemistry and patients with 2+ and 3+ result will also have FISH done. This will not affect patient management
- Overview of Data collection Dr.Bhawna Sirohi the principal investigators will maintain and supervise data collection and maintaining records. The patient will be de-identified.
- Selection of Study Population
Inclusion Criteria:
100 consecutive patients with gastric cancer who have a pathology specimen at TMH
Exclusion Criteria:
If histopathology blocks were not available
- Sample size 100 to be enrolled. Patient consent waiver applied for as this does not affect patient care 6) Statistical Analysis It is an Observational study so Results will be given as %age of total population.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 100 consecutive Gastric Cancer
Key inclusion criteria (1 listed)
- 100 consecutive patients with gastric cancer who have a pathology specimen at TMH
Key exclusion criteria (1 listed)
- If histopathology blocks were not available
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 testing in Gastric cancer
Time frame: 6 month
Immuno-histochemistry will be done in all patients. Patients with 2 and 3+ IHC will also have FISH done.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2017.
- 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.
Dr Bhawna Sirohi, MBBS DCH principal investigator
Consulting Medical Oncologist
Shailesh Shrikhande, MS principal investigator
Professor of Surgical GI and HPB surgery
Mukta Ramadwar, MD principal investigator
Consultant Pathologist
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 Tata Memorial Hospital at 1 site in India.
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: stopped early, as of the sponsor's last update on 27 Apr 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 India. 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 was stopped early. 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?
Incidence of Her2 testing in Gastric cancer (time frame: 6 month). 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 27 Apr 2017.