Concordance Between Liquid and Tissue Biopsy

NCT04241237 | Unknown

• 1 other identifier: Concordance
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Neoplasms

Keywords

Breast Cancer; Circulating Tumor Cells; Circulating Tumor DNA; Liquid Biopsy; Tissue biopsy; Concordance

Outcome Measures

Primary Outcomes (1)

• Concordance between liquid and tissue biopsy in terms of presence or absence of Cancer

  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

  Its a single visit study and the study investigators try to have a blood draw from patients within 30 days prior to tissue biopsy.

Secondary Outcomes (3)

• Concordance between liquid and tissue biopsy in terms of hormone and HER2 status

  Its a single visit study and study investigators try to have a blood draw from patients within 30 days prior to tissue biopsy.

• Classification of tissue biopsy results

  Its a single visit study and study investigators try to have a blood draw from patients within 30 days prior to tissue biopsy.

• Exploratory analysis

  Its a single visit study and study investigators try to have a blood draw from patients within 30 days prior to tissue biopsy.

Study Arms (1)

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

Interventions

Blood Draw PROCEDURE

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

Metastatic Breast Cancer patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study cohort will be selected from the Breast Cancer patients visiting London Regional Cancer Program for the treatment of their disease.

You may qualify if:

• Adult (≥18 years of age) diagnosed with primary breast cancer (BC) any subtype ER/PgR+ and HER2, triple negative or HER2+ at least 6 months before suspected metastases were identified
• Patients must have suspected recurrent metastatic BC that will be confirmed by tissue biopsy that is expected to yield tissue adequate for histologic examination (sampling expected to yield material for cytologic evaluation only does not satisfy this criterion)
• The suspected metastases 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

You may not qualify if:

• Only locoregional recurrence (ipsilateral breast, axilla, infra/supraclavicular) suspected (see above regarding potential contralateral axillary or infra/supraclavicular metastases as only site of metastasis)
• Tissue biopsy occurs prior to blood collection for CTCs and ctDNA
• New treatment for suspected metastases commences prior to blood collection for CTCs and ctDNA
• Patient has received previous lines of systemic treatment for metastatic BC
• Previous history of an invasive non-BC apart from cancers treated with curative intent at least 5 years previously with no recurrence since diagnosis, with the exception of a non-melanoma skin cancer
• Patients unable or unwilling to undergo a tissue biopsy
• Patients unable to provide informed consent
• Patients undergoing only cytologic evaluation of suspected metastases

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• Epic Sciences: collaborator
• University of Western Ontario, Canada: collaborator
• Lunenfeld Tanenbaum Research Institute: collaborator
• MOUNT SINAI HOSPITAL: collaborator
• Toronto Sunnybrook Regional Cancer Centre: collaborator
• University of Toronto: collaborator

Study Sites (1)

London Regional Cancer Program

London, Ontario, N6A 5W9, Canada

RECRUITING

Related Publications (16)

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Biospecimen

Retention: SAMPLES WITH DNA

Blood and archival tissue

MeSH Terms

Conditions

Breast Neoplasms; Neoplastic Cells, Circulating

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Ana Lohmann, MD, PhD

  London Regional Cancer Program

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robin Sachdeva, PhD

CONTACT

519-685-8500; robin.sachdeva@lhsc.on.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2020
• First Posted: January 27, 2020
• Study Start: July 1, 2020
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: September 2, 2021

Record last verified: 2021-08

Locations

CA (1)