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Lung Neoplasms

The Idylla EGFR Mutation Test, performed on the BioCartis Idylla System, is an in vitro diagnostic test for the qualitative detection of exon mutations. One of the biggest challenges in oncology biomarker testing is the ability to obtain samples of sufficient size and quality. This study can help test the BioCartis Idylla System against standard of care (SoC) pathology results from tissue biopsies in the same setting, ultimately being able to diagnose with a fraction of the tissue previously needed.

This diagnostic test is performed on the BioCartis Idylla System for qualitative detection of exon mutations.

Idylla EGFR Mutation Test

Hannah Park, BS

So Hyeon Park, MS

Anthony Magliocco, MD

This retrospective, observational study will compare the results of a BioCartis' EGFR mutation test on the Idylla platform with test results from SoC pathology results from tissue biopsies in the same setting. A comparable rapid testing platform for EGFR may serve as a more accessible means to diagnose, and overall, more patients treated successfully with targeted therapies. Up to 150 samples will be tested and compared with existing results.

This study will compare the results of a BioCartis' EGFR mutation test on theIdylla platform with test results from standard of care (SoC) pathology results from tissue biopsies. The Idylla™ EGFR Mutation Test, performed on the BioCartis Idylla™ System, is an in vitro diagnostic test for the qualitative detection of exon 18, exon 20, and exon 21 mutations. Additionally, exon 19 deletions and exon 20 insertions in the EGFR oncogene. A rapid testing platform for EGFR may serve as a more accessible means to diagnose, and overall, more patients treated successfully with targeted therapies.

Idylla EGFR Lung Trial

Technology Study: Measuring Potential Impact of Research Use Only Rapid EGFR Testing on Standard of Care

The primary outcome measured is if the Idylla EGFR Mutation Test is a possible alternative to diagnose EGFR mutation status in tissue samples.

Anthony Magliocco

Principal Investigator

Symptoms and General Pathology

Skin and Connective Tissue Diseases

Neoplasm Metastasis

Breast Neoplasms

Recurrence

Breast Diseases

Skin Diseases

Investigators plan to enroll patients previously diagnosed with a primary breast cancer of any subtype at least six (6) months before presentation with suspected metastases or be presenting with de novo metastasis The suspected metastases in these patients must be outside the ipsilateral breast, axilla infra/supraclavicular areas. In those with suspected metastases in contralateral axilla, infra/supraclavicular areas only a new contralateral breast primary must be excluded by physical exam, mammogram or MRI

If a tissue biopsy is performed, the matched tissue will be sent to the central pathology lab for reanalysis. If a tissue biopsy was performed, but the tissue block is exhausted or unavailable, patients are still eligible to participate in the study.

Investigators plan to enroll patients previously diagnosed with a primary breast cancer of any subtype at least six (6) months before presentation with suspected metastases or be presenting with de novo metastasis The suspected metastases in these patients must be outside the ipsilateral breast, axilla infra/supraclavicular areas. In those with suspected metastases in contralateral axilla, infra/supraclavicular areas only a new contralateral breast primary must be excluded by physical exam, mammogram or MRI.

A contemporaneous tissue biopsy is optional for this cohort.

Blood will be drawn from each patient to check the concordance between liquid and tissue biopsy

Blood Draw

Joseph M Viscomi, BS

Jayme Ion

Nithya Sundararaman

Delia C Guaqueta Segura, MD

Sanjit Nirmandalahan, PhD

Darcy Benedetto

Rama Balaraman, MD

Jon-Michael Eckert

Russell Novak, MD

Laura Lozano

Karen Zwicky, MS

Marina Messinger, MD

Prena Etchen

Benjamin Duva

Jesus D Anampa Mesias, MD

Laura Brady

Joseph Battelli

Richard Zuniga, MD

Rashmi Nagaraj, MSc

Andreea Badea

Gary Groot, MD

The purpose of this study is to continue to develop a liquid biopsy (minimally invasive blood test) that can be used to confirm if breast cancer has spread throughout the body and if this liquid biopsy test can provide comparable information to a highly invasive tissue biopsy. The knowledge gained in this study could be used in future studies to confirm cancer recurrence using a safe and minimally invasive procedure. The research will consist of looking for tumor cell(s) circulating in the blood stream and if they are present to characterize them so that more information about the disease can be collected. This information may help us to better understand how to fight cancer.

An estimated 287,850 women will be diagnosed with invasive breast cancer in the US in 2022 (cancer.org). Most women with breast cancer present with disease confined to the breast and local lymph nodes, where surgical removal of lesions is standard of care and well-managed. Those diagnosed and treated for primary breast cancer often recur with metastatic disease more than 5 years after initial diagnosis. (Pan, NEJM 2017).

Sadly, when lesions emerge in other areas, after months or decades with no evidence of disease, mortality rates rise. The most common sites of distant recurrence of breast cancer are the bone, lung, liver, and brain, (Lin, NCCN 2012), all of which are difficult to biopsy, and obtain pathological evidence of malignancy because metastatic lesions: 1) are not always accessible/deeply located, 2) are prone to under sampling, and 3) may present dense fibrotic tissue. In addition, tissue biopsy methods in metastatic lesions have been shown to:

1. have low patient compliance,
2. have high discordance rate with malignant lesions at imaging,
3. be incompatible with longitudinal monitoring.

As a result, at a critical point in patient care, there is still a current unmet need for diagnostic information to guide decision-making.

As established widely in published literature over the past decade, receptor status often changes between primary and metastatic disease, and during lines of metastatic treatments, changing the trajectory of the disease and further highlighting the need for longitudinal evaluation of receptor status. Occult micro-metastases or minimal residual disease (MRD) cannot be detected with current medical modalities and can originate metastatic relapse at distant sites. For this reason, cellular and molecular liquid biopsy approaches that enable detection of disease relapse allow therapy escalation many months earlier than overt relapse detected by imaging which as result may increase patients' survival. Based on discussions, interviews, and surveys of both thought-leading academics and community-based medical oncologists, there is an evident opportunity to improve patient care. Moreover, the market shows receptivity to a blood-based test for these inaccessible cases as well as improve identification of patients at high risk of relapse or eligible for earlier treatment escalation compared to current tissue biopsy testing in practice today.

In this clinical trial the purpose is to examine the potential of blood draws as a rapid and less invasive alternative to biopsies. Additionally, to compare the results of Epic Sciences' liquid biopsy test, DefineMBC, with results of standard-of-care (SoC) pathology results from metastatic contemporaneous tissue biopsies. With the implementation of our newest Registry Arm of patients, our goal is also to provide participating physician investigators the results Epic Sciences' liquid biopsy test, Define MBC, for breast cancer subjects with no central pathology data and utilize physician feedback for test experience improvements.

Breast Cancer Liquid Biopsy Trial

Liquid vs Tissue Biopsy Concordance in Samples of 1st Suspected BCa Recurrence/Metastasis and Evaluation of DefineMBC Comprehensive Cancer Profiling Liquid Biopsy LDT

To analyze concordance between liquid biopsy, Circulating tumor (ct) cells and ctDNA (academic assays based on mutations and/or epigenetic changes), with biopsy results (presence or absence of cancer), and with all blood assays being conducted blinded to tissue biopsy results

After confirmation of tumor area and cellularity, slides will be stained with the appropriate Immunohisto Chemistry: Progesterone Receptor (clone 1E2), Estrogen Receptor (clone SP1), GATA3, TTF1, PD-L1 (SP142), FOXA1, or HER2 (4B5).

Exploratory analyses will include agreement of GATA3, FOXA1 and PDL1 staining results between liquid and tissue biopsies, where possible.

Secondary analysis of the concordance between hormone receptor and HER status identified on tissue with identified CTCs

To provide participating physician investigators the results Epic Sciences' liquid biopsy test, Define MBC, for breast cancer subjects with no central pathology data and utilize physician feedback for test experience improvements

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Idylla EGFR Lung Trial	NCT04962191	Lung Cancer Technology Oncology	Idylla EGFR Mut...	18 Years -	Protean BioDiagnostics
Breast Cancer Liquid Biopsy Trial	NCT04962529	Breast Cancer Cancer	Blood Draw	18 Years -	Protean BioDiagnostics
Breast Cancer Liquid Biopsy Trial	NCT04962529	Breast Cancer Cancer	Blood Draw	18 Years -	Protean BioDiagnostics

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