Concordance of the IHC4 Score Performed in Local or Central Laboratory to Endopredict in ER+/HER2- Breast Cancer (GEFPICS IHC4)
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|ClinicalTrials.gov Identifier: NCT04246606|
Recruitment Status : Recruiting
First Posted : January 29, 2020
Last Update Posted : May 8, 2020
|Condition or disease||Intervention/treatment|
|Breast Neoplasm Female||Diagnostic Test: IHC4 score|
The IHC4 prognostic signature is an algorithm based on a combination of biomarkers evaluated in immunohistochemistry and anatomical-clinical parameters. Immunohistochemistry is routinely performed as a diagnostic procedure for estrogen receptor (ER; H-score 0-300), progesterone receptor (PR; % of marked cells), HER2 (positive vs negative status) and Ki67 (% of marked cells evaluated by counting). Clinical parameters include lymph node status (0N+, 1-3N+, >3N+, >3N+), tumour size in mm (≤10mm, 11-20, 21-50, >50mm), histologic grade (1, 2, 3), patient's age at diagnosis (<65 years, ≥65 years), and type of treatment (anti-estrogen or aromatase inhibitors).
The method for reading and scoring conditions is very precise and currently guarantee the validity of the test (validated centrally in TransATAC). However, there is not yet an open access web platform available for the calculation of the IHC4 score, due to the prior need for homogenisation of the interpretation of immunochemistry (standardisation of the protocol) to generate a reliable and validated IHC4 under decentralised "real life" conditions. There is currently few published data on the weight of technical parameters (antibody clones, automaton type, etc.) or interpretation methods (scoring) in the calculation of the IHC4 score (IHC4 robustness). However, only one study, published recently, shows a good tolerance of the test to variations in technical protocol or reading.
In this context, a study coordinated by the GEFPICS group, composed of expert pathologists in breast cancer, has been set up to better define the robustness and the scope of IHC4 score. These project will assess 2 main aspects: (i) validate the local "real life" technique for the calculation of the IHC4 score; and (ii) homogenise the IHC reading method (especially for Ki67), on a cohort of cases from the GEFPICS, tested in a prognostic molecular signatures.
|Study Type :||Observational|
|Estimated Enrollment :||155 participants|
|Official Title:||Retrospective Study Assessing the Concordance of the IHC4 Score Performed in Local Pathology Laboratory or in a Central Laboratory to a Molecular Gold Standard Test Endopredict in Breast Cancer Infiltrating ER+ HER2-|
|Actual Study Start Date :||April 24, 2020|
|Estimated Primary Completion Date :||June 30, 2020|
|Estimated Study Completion Date :||December 30, 2020|
ER+/HER2- infiltrating early breast cancer
Patients with ER+/HER2- infiltrating early breast cancer for which EndoPredict molecular signature was performed.
Diagnostic Test: IHC4 score
The IHC4 score is a prognostic tool that incorporates immunohistochemical parameters of ER (H-score), PR (% of positive cells), HER2 (positive or negative status), and Ki67 (% of positive cells).
IHC4 score, combined with nodal status and tumor grade, age, and the type of endocrine therapy (tamoxifen or aromatase inhibitors) provides a clinical score IHC4+C.
IHC4+C provides a prognostic risk of distant recurrence at 10 years for patients who underwent endocrine therapy for 5 years. IHC4+C defined three distinct risk categories:
- To assess the reproducibility of the IHC4 score testing performed in local pathology laboratory (i.e. real life) to in a central laboratory. [ Time Frame: Day 1 ]Inter-laboratory concordance rate of IHC4 score performed in a local laboratory versus central laboratory. The equivalence of the two methods is defined as a ≥90% concordance rate.
- To assess the inter-observer reproducibility of IHC4 scoring carry out by different local pathologists on digitalised slides. [ Time Frame: Day 1 ]Inter-observer reproducibility of IHC4 scoring carry out by different local pathologists on digitalised slides.
- Reproducibility of IHC4+C score compare to the molecular gold standard EPclin (Endopredict). [ Time Frame: Day 1 ]To assess the consistency of IHC4+C score (IHC4 combined with nodal status and tumor grade) to the molecular gold standard EPclin (Endopredict).
- To assess the consistency of the IHC4 scoring performed by a pathologist to an automatic image recognition algorithm. [ Time Frame: Day 1 ]Inter-observer reproducibility of IHC4 scoring carry out by a pathologist to an automatic image recognition algorithm
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04246606
|Contact: Etienne Lonchamp, PhD||0033 1 85 34 36 firstname.lastname@example.org|
|Contact: Jérôme Lemonnier, PhD||0033 1 71 93 67 email@example.com|
|Centre Antoine Lacassagne||Recruiting|
|Nice, France, 06180|
|Principal Investigator: Juliette Haudebourg, MD|
|Principal Investigator:||Juliette Haudebourg, MD||Centre Antoine Lacassagne|