Immunohistochemical HER2 Status Evaluation In Breast Cancer Pathology Samples: A Multicenter, Parallel-Design Concordance Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 5
- 主要终点
- Kappa Coefficient as a Measure of Agreement Between Abroad and Trial Sites (A, B, C, D and E) Concerning the IHC Test of Breast Tissue Samples
研究概览
简要总结
A multi-center non-interventional, in-vitro trial for evaluation of concordance of the results for Human Epidermal Growth Factor Receptor 2 (HER2) expression by the Immunohistochemical (IHC) method in pathological samples collected from participants with breast cancer.
详细描述
For accurate selection of participants who will be treated with anti-HER2, primary crucial thing to do is the right identification of HER2 in breast tumor cells. The advantages and disadvantages of IHC and In-Situ Hybridization (ISH) for the detection of HER2 status is still disputable. It is generally agreed on that HER2 study should be applied on all invasive breast cancer participants. It can be used together with IHC which measures HER2 protein expression or ISH which assesses HER2 gene amplification. With regard to IHC, the inconsistency of sensitivity and specificity of marketed antibodies, differences in interpretation and technical artifacts cause problems in diagnosis on occasion. There is not enough study on reasons which cause the consistence and discrepancies between laboratories in HER2 detection with IHC method.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Samples that fulfill all of the criteria will be evaluated for the study.
- •Samples of women aged greater than or equal to (>/=) 18 and less than (<) 75 years
- •Tumor samples already diagnosed based on the IHC score of 0 to +3
- •Samples of primary lesions excluding lymph nodes
- •10 percent (%) neutral buffered formalin-fixed and paraffin embedded tissue samples
排除标准
- •Samples that fulfill any of the criteria below will not be included in the study.
- •Non-invasive ductal carcinoma (NOS) samples
- •Tru-cut biopsies
- •Non-breast cancer pathological samples
结局指标
主要结局
Kappa Coefficient as a Measure of Agreement Between Abroad and Trial Sites (A, B, C, D and E) Concerning the IHC Test of Breast Tissue Samples
时间窗: Up to 70 days
Inter-laboratory variation between the sites was assessed using Kappa test, K values to be interpreted as follows: a) \<0: less than chance agreement, b) 0.01-0.20: slight agreement, c) 0.21-0.40: fair agreement, d) 0.41-0.60: moderate agreement, e) 0.61-0.80: substantial agreement, and f) 0.81-0.99: almost perfect agreement.
Percentage of Participants With IHC Evaluation Between Sites B and Others (Sites C, D and E)
时间窗: Up to 70 days
IHC is a staining process performed on fresh/frozen breast cancer tissue. IHC is used to show whether or not the cancer cells have HER2 and/or hormone receptors on their surface. The IHC test gives a score of 0 to 3+ that measures the amount of HER2 receptor protein on the surface of cells in a breast cancer tissue sample. Score 0: cells free from immune staining, score 1 (+): is concluded in the case of stains not completely membranous and which do not surround the membranes regardless of quantity in the cells, or weak stains surrounding the entire membrane in less than 10% of the cells. Score 2 (++): is concluded in the presence of a moderate staining surrounding the cytoplasmic membrane in at least 10%, or strong membranous staining in less than 30% of the invasive carcinoma cells. Score 3 (+++): is concluded where IHC yields strong staining surrounding the entire cytoplasmic membrane in at least 30% of the invasive carcinoma cells.
Kappa Coefficient as a Measure of Agreement Between Site B and Others (Sites C, D and E) Concerning the IHC Test of Breast Tissue Samples
时间窗: Up to 70 days
Inter-laboratory variation between the sites was assessed using Kappa test, K values to be interpreted as follows: a) \<0: less than chance agreement, b) 0.01-0.20: slight agreement, c) 0.21-0.40: fair agreement, d) 0.41-0.60: moderate agreement, e) 0.61-0.80: substantial agreement, and f) 0.81-0.99: almost perfect agreement.
Kappa Coefficient (K) as a Measure of Agreement Between Site A and Others (Sites B, C, D and E) Concerning the IHC Test of Breast Tissue Samples
时间窗: Up to 70 days
Inter-laboratory variation between the sites was assessed using Kappa test, K values were interpreted as follows: a) less than (\<) 0: less than chance agreement, b) 0.01-0.20: slight agreement, c) 0.21-0.40: fair agreement, d) 0.41-0.60: moderate agreement, e) 0.61-0.80: substantial agreement, and f) 0.81-0.99: almost perfect agreement.
Percentage of Participants With IHC Evaluation Between Abroad and Trial Sites (A, B, C, D and E)
时间窗: Up to 70 days
IHC is a staining process performed on fresh/frozen breast cancer tissue. IHC is used to show whether or not the cancer cells have HER2 and/or hormone receptors on their surface. The IHC test gives a score of 0 to 3+ that measures the amount of HER2 receptor protein on the surface of cells in a breast cancer tissue sample. Score 0: cells free from immune staining, score 1 (+): is concluded in the case of stains not completely membranous and which do not surround the membranes regardless of quantity in the cells, or weak stains surrounding the entire membrane in less than 10% of the cells. Score 2 (++): is concluded in the presence of a moderate staining surrounding the cytoplasmic membrane in at least 10%, or strong membranous staining in less than 30% of the invasive carcinoma cells. Score 3 (+++): is concluded where IHC yields strong staining surrounding the entire cytoplasmic membrane in at least 30% of the invasive carcinoma cells.
Percentage of Participants With Immunohistochemical (IHC) Evaluation Between Site A and Others (Sites B, C, D and E)
时间窗: Up to 70 days
IHC is a staining process performed on fresh/frozen breast cancer tissue. IHC is used to show whether or not the cancer cells have Human Epidermal Growth Receptor (HER2) and/or hormone receptors on their surface. The IHC test gives a score of 0 to 3+ that measures the amount of HER2 receptor protein on the surface of cells in a breast cancer tissue sample. Score 0: cells free from immune staining, score 1 (+): is concluded in the case of stains not completely membranous and which do not surround the membranes regardless of quantity in the cells, or weak stains surrounding the entire membrane in less than 10% of the cells. Score 2 (++): is concluded in the presence of a moderate staining surrounding the cytoplasmic membrane in at least 10%, or strong membranous staining in less than 30% of the invasive carcinoma cells. Score 3 (+++): is concluded where IHC yields strong staining surrounding the entire cytoplasmic membrane in at least 30% of the invasive carcinoma cells.
Percentage of Participants With IHC Evaluation Between Site C and Others (Sites D and E)
时间窗: Up to 70 days
IHC is a staining process performed on fresh/frozen breast cancer tissue. IHC is used to show whether or not the cancer cells have HER2 and/or hormone receptors on their surface. The IHC test gives a score of 0 to 3+ that measures the amount of HER2 receptor protein on the surface of cells in a breast cancer tissue sample. Score 0: cells free from immune staining, score 1 (+): is concluded in the case of stains not completely membranous and which do not surround the membranes regardless of quantity in the cells, or weak stains surrounding the entire membrane in less than 10% of the cells. Score 2 (++): is concluded in the presence of a moderate staining surrounding the cytoplasmic membrane in at least 10%, or strong membranous staining in less than 30% of the invasive carcinoma cells. Score 3 (+++): is concluded where IHC yields strong staining surrounding the entire cytoplasmic membrane in at least 30% of the invasive carcinoma cells.
Kappa Coefficient as a Measure of Agreement Between Sites C, D and E Concerning the IHC Test of Breast Tissue Samples
时间窗: Up to 70 days
Inter-laboratory variation between the sites was assessed using Kappa test, K values to be interpreted as follows: a) \<0: less than chance agreement, b) 0.01-0.20: slight agreement, c) 0.21-0.40: fair agreement, d) 0.41-0.60: moderate agreement, e) 0.61-0.80: substantial agreement, and f) 0.81-0.99: almost perfect agreement.
次要结局
- Percentage of Participants With Diagnosis of Primary Tumor(Up to 70 days)
- Percentage of Participants With Pathological Score(Up to 70 days)
- Percentage of Participants With HER2 Test Form Based on Different Automated Slide Stainers(Up to 70 days)
- Percentage of Participants With Initial Tumor Node Metastasis (TNM) Stage According to Council Decision(Up to 70 days)
- Percentage of Participants With HER2 Test Form Based on Country(Up to 70 days)
- Percentage of Participants With HER2 Test Form Based on Primary Antibody(Up to 70 days)
- Percentage of Participants With Specified Density of Hormone Receptors(Up to 70 days)
- Percentage of Participants With HER2 Test Form Based on Antigen Retrieval(Up to 70 days)
- Percentage of Participants With Different IHC Results(Up to 70 days)
- Percentage of Participants With Pathological Grade(Up to 70 days)
- Percentage of Participants With Different Hormone Receptors(Up to 70 days)