Breast CancerNCT02654431
Identification and Semi -Quantification of ER/PR Proteins Expression
An observational study of Breast Cancer, run by Applied Spectral Imaging Ltd. at 1 site in United States.
Trial summary
The purpose of the study is the identification and quantification of proteins expression level in breast cancer tissues. The imaging system is intended for diagnostic use as an aid to the pathologist in the detection, counting and classifying ER/PR IHC stained samples. Read more about this study
- Who is it for?
- Ages 20 to 80 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Breast Cancer patient and Cancer patients
- Type of treatment
- Surgery or procedure
- How many people
- 350 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Dec 2014
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Breast cancer patients
Who may be able to join
- Women having breast cancer
Who cannot join
- others
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identification and Semi -Quantification of ER/PR Proteins Expression Status in Formalin Fixed, Paraffin-embedded Normal and Neoplastic Tissue
The purpose of the study is the identification and quantification of proteins expression level in breast cancer tissues.
The imaging system is intended for diagnostic use as an aid to the pathologist in the detection, counting and classifying ER/PR IHC stained samples.
Read the detailed description
The anti ER/PR Kit is a semi-quantitative immunohistochemical (IHC) assay to identify the progesterone (PR) and estrogen (ER) expressions in formalin-fixed, paraffin-embedded human breast cancer tissue specimens. Results from the ER/PR test is indicated as an aid in the assessment of the hormones status of breast cancer patients. While the ER/PR kit provides the antibodies that offer direct visualization and semi-quantification of the protein expression through a brightfield microscope, the GenASIs GoPath system is designed to complement the routine workflow of the pathologist in the review of immunohistochemically stained histologic slides.
- Conditions
- Breast Cancer
- Being tested
- Breast Cancer patient, Cancer patients
- Keywords
- Immunohistochemical (IHC), ER/PR, Breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast Cancer patientProcedure or surgery
Samples
Cancer patientsProcedure or surgery
Samples
| Study group | Role | What they receive |
|---|---|---|
| Breast Cancer patients | Breast cancer patients Receives: Procedure: Breast Cancer patient; Procedure: Cancer patients | |
| women with breast cancer | women with breast cancer Receives: Procedure: Breast Cancer patient; Procedure: Cancer patients | |
| Cancer patients | Cancer patients Receives: Procedure: Breast Cancer patient; Procedure: Cancer patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
IVD study of ER/PR IHC samples: Accuracy of analysis
Comparison tests (accuracy) between manual and automatic analysis of antibody expressions. The results from the automatic counting from the clinical studies will be compared to the manual counting analysis.
Accuracy of the study will be declared "Success" if Positive, Negative and Overall agreement with manual count of the ER \& PR antibody at least 90%.
Measured: 1 Day
IVD study of ER/PR IHC samples: Repeatability & Reproducibility of analysis
Repeatability \& Reproducibility tests of system analysis of antibody expressions. R\&R acceptance criteria of ER/PR are related to the average agreement for between runs, between days and between systems R\&R part of the study will be declared "Success" if Positive and Negative average agreement will be at least 85%.
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2016 (estimated)
- Study startMay 2013
- Primary completionMay 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Applied Spectral Imaging Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sheila Dobin, Study chair, Section Chief, Cytogenetics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02654431
- Sponsor's protocol ID
- ASI-ER/PR-IHC
- Status last verified
- Jan 2016
- First submitted
- 26 Jun 2014
- Last updated
- 13 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification and Semi -Quantification of ER/PR Proteins Expression Status in Formalin Fixed, Paraffin-embedded Normal and Neoplastic Tissue
- ClinicalTrials.gov ID
- NCT02654431
- Acronym / sponsor ID
- ASI-ER/PR-IHC
- Conditions
- Breast Cancer
- Keywords
- Immunohistochemical (IHC), ER/PR, Breast cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Applied Spectral Imaging Ltd.Industry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- May 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 13 Jan 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.
The purpose of the study is the identification and quantification of proteins expression level in breast cancer tissues.
The imaging system is intended for diagnostic use as an aid to the pathologist in the detection, counting and classifying ER/PR IHC stained samples.
Detailed description
The anti ER/PR Kit is a semi-quantitative immunohistochemical (IHC) assay to identify the progesterone (PR) and estrogen (ER) expressions in formalin-fixed, paraffin-embedded human breast cancer tissue specimens. Results from the ER/PR test is indicated as an aid in the assessment of the hormones status of breast cancer patients. While the ER/PR kit provides the antibodies that offer direct visualization and semi-quantification of the protein expression through a brightfield microscope, the GenASIs GoPath system is designed to complement the routine workflow of the pathologist in the review of immunohistochemically stained histologic slides.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Breast Cancer patients | – | Procedure: Breast Cancer patient, Procedure: Cancer patientsBreast cancer patients |
| women with breast cancer | – | Procedure: Breast Cancer patient, Procedure: Cancer patientswomen with breast cancer |
| Cancer patients | – | Procedure: Breast Cancer patient, Procedure: Cancer patientsCancer patients |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Breast cancer patients
Key inclusion criteria (1 listed)
- Women having breast cancer
Key exclusion criteria (1 listed)
- others
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 |
|---|---|---|
| Breast Cancer patientSamples | Procedure or surgery | Breast Cancer patients, Cancer patients, women with breast cancer |
| Cancer patientsSamples | Procedure or surgery | Breast Cancer patients, Cancer patients, women with breast cancer |
Primary outcome
IVD study of ER/PR IHC samples: Accuracy of analysis
Time frame: 1 Day
Comparison tests (accuracy) between manual and automatic analysis of antibody expressions. The results from the automatic counting from the clinical studies will be compared to the manual counting analysis. Accuracy of the study will be declared "Success" if Positive, Negative and Overall agreement with manual count of the ER \& PR antibody at least 90%.
IVD study of ER/PR IHC samples: Repeatability & Reproducibility of analysis
Time frame: 1 Day
Repeatability \& Reproducibility tests of system analysis of antibody expressions. R\&R acceptance criteria of ER/PR are related to the average agreement for between runs, between days and between systems R\&R part of the study will be declared "Success" if Positive and Negative average agreement will be at least 85%.
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 13 Jan 2016.
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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.
Sheila Dobin study chair
Section Chief, Cytogenetics
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 Breast Cancer, run by Applied Spectral Imaging Ltd. at 1 site in United States.
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: finished, as of the sponsor's last update on 13 Jan 2016. 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 United States. 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?
IVD study of ER/PR IHC samples: Accuracy of analysis (time frame: 1 Day). The study lists 2 primary outcomes in all. 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 Jan 2016.