A Study Of VENTANA TROP2 (EPR20043) Device In Non-Small Cell Lung Cancer (NSCLC)

Overview

About this study

The purpose of this study is to evaluate the inter-laboratory site and reader variability of the VENTANA TROP2 (EPR20043) Device, RUO used with OptiView DAB IHC Detection Kit on the BenchMark ULTRA instrument and DP 200/DP 600 scanners in determining the TROP2 expression level in FFPE NSCLC.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Specimen must consist of de-identified FFPE human NSCLC tissue;

  • Specimen must contain sufficient tumor tissue of consistent morphology throughout the tissue block (based on the RTD pathologists’ reviews of bracketing slides stained with H&E); and

  • Specimen must exhibit consistent TROP2 expression throughout the tissue block (based on the RTD pathologists’ reviews of bracketing slides stained with the VENTANA TROP2 (EPR20043) Rabbit Monoclonal Antibody, RUO)

Exclusion Criteria:

  • The amount of tumor tissue is insufficient to cut and mount the required number of tissue sections for use in the study;

  • Specimen exhibits significant tumor tissue loss throughout the tissue block (based on the RTD pathologists’ review);

  • Specimen is a fine needle aspirate or cytology specimen; or

  • Specimen consists of tissue that has been decalcified

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

 

Eligibility last updated 05/09/2025. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Anja Roden

Contact us for the latest status

Contact information:

Anja Roden

(507) 422-7790

Roden.Anja@mayo.edu

More information

Publications

Publications are currently not available
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CLS-20597177

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