Concordance Between Liquid and Tissue Biopsy
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|ClinicalTrials.gov Identifier: NCT04241237|
Recruitment Status : Recruiting
First Posted : January 27, 2020
Last Update Posted : November 23, 2020
Tissue biopsy is a procedure to remove a piece of tissue (sample of cells) from the body to be analyzed in a laboratory, and it is commonly performed to confirm diagnosis of a patient with symptoms of breast cancer recurrence. It may also provide information on tumor markers (hormone receptors, HER2) that can guide treatment decisions. The goal of this study is to determine whether blood tests (which require less-invasive procedures) can be used to confirm diagnosis of suspected recurrent breast cancer (as compared to tissue biopsy).
Investigators plan to investigate blood factors which include circulating tumor cells (CTCs - i.e., cancer cells that can be detected in the blood), circulating tumor DNA (ctDNA - i.e., pieces of DNA from cancer cells that can be found in the blood), as well as other biomarkers. Investigators will conduct this study in 120 participants who present with suspected breast cancer recurrence and symptoms of cancer that has spread to other areas in the body.
Participants will be asked for blood collection within 30 days before tissue biopsy. The tissue will be analysed locally to determine the presence of cancer and the tumor markers listed above. The blood will be processed and stored for analysis of CTCs and ctDNA. If these blood tests show concordance with tissue based tests (presence of cancer cells, hormone receptors & HER2 status), these tests could be used in future studies to confirm diagnosis using a non-invasive procedure. Also, investigators believe that the results of this study can influence other research of early-stage recurrent breast cancer.
|Condition or disease||Intervention/treatment|
|Breast Neoplasms||Procedure: Blood Draw|
In Canada, it is estimated that more than 26,900 women will be diagnosed with breast cancer (BC), and 5,000 women will die from BC in 2019. Metastatic BC will cause the vast majority of these deaths. Tissue biopsy is recommended to confirm recurrence (presence of cancer cells) in patients with a history of previous BC. Additionally, tissue biopsy provides information on BC subtypes (estrogen receptor (ER), progesterone receptor (PgR), and HER2 status). Technological advances over the last several years have led to more robust methods for the detection, quantification, and characterization of liquid biopsy (including CTCs and ctDNA) in recurrent BC. If these approaches demonstrate sufficiently concordant results to tissue-based testing, blood draws may quickly become a viable alternative to invasive biopsies.
In a cross-sectional study, 120 consecutive individuals from study centers in Ontario, who present with highly suspicious BC distant metastases who undergo biopsy to confirm BC recurrence will be enrolled (enrollment will be continued until 100 subjects with confirmed metastatic breast cancer have been enrolled). Blood samples for the circulating factors will be taken within 30 days prior to the tissue biopsy. Patient and tumor characteristics will be recorded. At the end of study, liquid biopsy (CTCs and ctDNA) analyses will be performed blinded to biopsy results. Investigators will continuously review the number of participants in each BC subtype. Cases with tissue biopsy results not classified as definite or highly suspicious for metastatic breast cancer by the treating physician will be re-assessed after six month of study entry in an attempt to classify them as having metastatic breast cancer or not. This aims to confirm/rule out breast cancer or other diagnosis.
The overall anticipated public and/or scientific benefit of the study is to demonstrate the concordance between liquid (blood) biopsy and tissue based tests in terms of the presence of cancer cells, hormone receptors, HER2 status etc. so these tests could be used in the future to confirm diagnosis using a non-invasive procedure. The results of this study will advance our understanding of liquid biomarkers and ideally improve the care journey for breast cancer patients by not subjecting them to invasive and potentially dangerous biopsy procedures.
|Study Type :||Observational|
|Estimated Enrollment :||120 participants|
|Official Title:||Concordance Between Liquid and Tissue Biopsy in Newly Diagnosed Metastatic Breast Cancer|
|Actual Study Start Date :||July 1, 2020|
|Estimated Primary Completion Date :||April 2021|
|Estimated Study Completion Date :||April 2021|
Metastatic Breast Cancer patients
Investigators plan to enroll patients who are undergoing biopsy for potential metastatic Breast Cancer any subtype ER/PgR+ and HER2, triple negative or HER2+ at least 6 months before suspected metastases were identified. 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 and MRI
Procedure: Blood Draw
Blood will be drawn from each patient to check the concordance between liquid and tissue biopsy
- Concordance between liquid and tissue biopsy in terms of presence or absence of Cancer [ Time Frame: Its a single visit study and the study investigators try to have a blood draw from patients within 30 days prior to tissue biopsy. ]To analyze concordance between liquid biopsy, CTCs (Epic Sciences) 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
- Concordance between liquid and tissue biopsy in terms of hormone and HER2 status [ Time Frame: Its a single visit study and study investigators try to have a blood draw from patients within 30 days prior to tissue biopsy. ]To conduct secondary analyses of the concordance between hormone receptor and HER2 status identified on tissue specimens with those identified on CTCs (Epic Sciences).
- Classification of tissue biopsy results [ Time Frame: Its a single visit study and study investigators try to have a blood draw from patients within 30 days prior to tissue biopsy. ]To classify tissue biopsy results according to the interpretation of the local pathologist, the treating physician (primary comparator) and the study investigators (interpretations to include clinical data such as physical exam, radiologic investigations, blood work as available).
- Exploratory analysis [ Time Frame: Its a single visit study and study investigators try to have a blood draw from patients within 30 days prior to tissue biopsy. ]To conduct exploratory analyses of the associations between tumor markers and CTCs or ctDNA.
Biospecimen Retention: Samples With 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): NCT04241237
|Contact: Robin Sachdeva, PhD||519-685-8500 ext firstname.lastname@example.org|
|London Regional Cancer Program||Recruiting|
|London, Ontario, Canada, N6A 5W9|
|Contact: Robin Sachdeva, PhD 519-685-8500 ext 54005 email@example.com|
|Principal Investigator: Ana Lohmann, MD, PhD|
|Principal Investigator:||Ana Lohmann, MD, PhD||London Regional Cancer Program|