Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2026-04-23 @ 11:14 PM
Study NCT ID:
NCT02654457
Status:
COMPLETED
Last Update Posted:
2016-01-13
First Post:
2015-02-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Identification and Semi-Quantification of Ki-67 Protein Expression Status
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-12', 'studyFirstSubmitDate': '2015-02-05', 'studyFirstSubmitQcDate': '2016-01-12', 'lastUpdatePostDateStruct': {'date': '2016-01-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-01-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'IVD study of Ki67 IHC samples: Accuracy of analysis', 'timeFrame': '1 Day', 'description': '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.\n\nAccuracy of the study will be declared "Success" if Positive, Negative and Overall agreement with manual count of the Ki67 antibody at least 85%.'}, {'measure': 'IVD study of Ki67 IHC samples: Repeatability & Reproducibility of analysis', 'timeFrame': '1 Day', 'description': 'Repeatability \\& Reproducibility tests of system analysis of antibody expressions. R\\&R acceptance criteria of Ki67 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 80%.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Immunohistochemical', 'Ki-67', 'Breast cancer', 'IHC'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is the identification and semi-quantification of Ki-67 protein expression level in breast cancer tissues by the GenASIs GoPth system as compared to manual reading of the same slides.\n\nThe imaging system is intended for diagnostic use as an aid to the pathologist in the detection, counting and classifying ER/PR IHC stained samples', 'detailedDescription': 'The anti Ki-67 is a semi-quantitative immunohistochemical (IHC) assay to identify the Ki-67 protein expressions in formalin-fixed, paraffin-embedded human breast cancer tissue specimens. Results from the Ki-67 test is indicated as an aid in the assessment of the protein status of breast cancer patients. While the p53 kit provides the antibody 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 analysis and review of immunohistochemically stained histologic slides.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '21 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Women having breast cancer aged 21 and up', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Slides with nuclear borders of tumor nuclei that is distinguishable, and having good integrity.\n\nExclusion Criteria:\n\n* Slides that have lots of background that interfere with the analysis'}, 'identificationModule': {'nctId': 'NCT02654457', 'briefTitle': 'Identification and Semi-Quantification of Ki-67 Protein Expression Status', 'organization': {'class': 'INDUSTRY', 'fullName': 'Applied Spectral Imaging Ltd.'}, 'officialTitle': 'Identification and Semi-Quantification of Ki-67 Protein Expression Status in Formalin Fixed, Paraffin-embedded Normal and Neoplastic Breast Tissue', 'orgStudyIdInfo': {'id': 'ASI-Ki-67-IHC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Women with Breast Cancer #1', 'description': 'IVD Study', 'interventionNames': ['Procedure: Women with Breast Cancer']}, {'label': 'Women with Breast Cancer #2', 'description': 'IVD Study', 'interventionNames': ['Procedure: Women with Breast Cancer']}, {'label': 'Women with Breast Cancer #3', 'description': 'IVD Study', 'interventionNames': ['Procedure: Women with Breast Cancer']}], 'interventions': [{'name': 'Women with Breast Cancer', 'type': 'PROCEDURE', 'description': 'IVD Study', 'armGroupLabels': ['Women with Breast Cancer #1', 'Women with Breast Cancer #2', 'Women with Breast Cancer #3']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Applied Spectral Imaging Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}