Breast CancerNCT00978276
Immunohistochemical (IHC) Scoring for Receptors Expression in Breast Tissues
An observational study of Breast Cancer, run by Applied Spectral Imaging Ltd..
Trial summary
The purpose of this study is the identification and classification of human tissues and cytology specimens and elements therein. Computer aided technology to assist the pathologists to identify, quantify, characterize and report their findings with regards to one or more diagnoses they should perform. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2006to not given
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The breast samples were taken from female patients after tru cut biopsies, lumpectomies or mastectomies. Paraffin embedded blocks were prepared from the specimens out of which sections were stained immunohistochemically with the Vision Bio Systems mouse monoclonal antibodies for Estrogen Receptor (NCL-ER-6F11) and Progesterone Receptor (NCL-PGR-312). All stages were performed under the routine procedure of the hospital laboratory.
Who may be able to join
- Well stained paraffin embedded tissue specimens
Who cannot join
- Fade away slides
About this study
Official title: Concordance Study for Over Expression Level of Antibodies Within Breast Tissues
The purpose of this study is the identification and classification of human tissues and cytology specimens and elements therein.
Computer aided technology to assist the pathologists to identify, quantify, characterize and report their findings with regards to one or more diagnoses they should perform. In particular and for example: the scoring of the number of elements and their protein (antibody) expression level within a paraffin embedded tissue section.
- Conditions
- Breast Cancer
- Keywords
- Receptors, Immunohistochemistry, Breast, Over expression of Hormone receptors in carcinoma of the breast sues
- Medical subject headings
- Breast Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2009 (estimated)
- Study startMay 2006
Why it stopped: Personal changes in the company
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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Applied Spectral Imaging Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00978276
- Sponsor's protocol ID
- ASI-IHC
- Status last verified
- Jan 2016
- First submitted
- 15 Sep 2009
- Last updated
- 5 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concordance Study for Over Expression Level of Antibodies Within Breast Tissues
- ClinicalTrials.gov ID
- NCT00978276
- Acronym / sponsor ID
- ASI-IHC
- Conditions
- Breast Cancer
- Keywords
- Receptors, Immunohistochemistry, Breast, Over expression of Hormone receptors in carcinoma of the breast sues
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Personal changes in the company
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Applied Spectral Imaging Ltd.Industry (pharma, biotech, devices)
- Study start
- May 2006
- First posted
- 16 Sep 2009 (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 this study is the identification and classification of human tissues and cytology specimens and elements therein.
Computer aided technology to assist the pathologists to identify, quantify, characterize and report their findings with regards to one or more diagnoses they should perform. In particular and for example: the scoring of the number of elements and their protein (antibody) expression level within a paraffin embedded tissue section.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The breast samples were taken from female patients after tru cut biopsies, lumpectomies or mastectomies. Paraffin embedded blocks were prepared from the specimens out of which sections were stained immunohistochemically with the Vision Bio Systems mouse monoclonal antibodies for Estrogen Receptor (NCL-ER-6F11) and Progesterone Receptor (NCL-PGR-312). All stages were performed under the routine procedure of the hospital laboratory.
Key inclusion criteria (1 listed)
- Well stained paraffin embedded tissue specimens
Key exclusion criteria (1 listed)
- Fade away slides
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
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Applied Spectral Imaging Ltd..
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: withdrawn, as of the sponsor's last update on 5 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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.
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 5 Jan 2016.