Validation of Molecular Diagnostic Assays to Detect Cancer Biomarkers in Blood & Primary Tumor in ER+/HER2- MBC
NCT ID: NCT04480814
Last Updated: 2025-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
30 participants
OBSERVATIONAL
2019-10-11
2022-02-08
Brief Summary
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Liquid biopsy is a non-invasive approach based on the extraction of information through peripheral blood analysis. It makes it possible to characterize the development of a solid tumor in real time, through detailed molecular analysis of circulating genetic material in peripheral blood.
Detailed Description
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Liquid biopsy is a non-invasive approach based on the extraction of information through peripheral blood analysis. It makes it possible to characterize the development of a solid tumor in real time, through detailed molecular analysis of circulating genetic material in peripheral blood.
Study procedure:
1. Initial Visit (V0-Baseline): For the purposes of the study the following information will be collected: the demographics, medical and social history, the characteristics of the disease (stage, molecular characterization e.t.c) and the treatment regimen that is followed. As part of the visit, 20 mL of peripheral blood will be drawn prior to their treatment according to physician's suggestion as per common clinical practice. Blood samples will be then sent to ACTC laboratory for plasma/CTC isolation, DNA and RNA extraction and subsequent test for biomarkers. Primary tumor tissue samples will be also collected
2. Follow-up visit (V1): Response to treatment by RECIST based on restaging CTs/MRIs will be documented during this visit, which will take place 3 months after treatment initiation. As part of the visit, 20 mL of peripheral blood will be drawn.
Blood samples will be then sent to laboratory for plasma/CTC isolation, DNA and RNA extraction and subsequent test for biomarkers. Survival status and clinical response (CR, PR, SD, PD) will be also documented.
Conditions
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Keywords
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Metastatic Breast Cancer
The study population are subjects with a confirmed diagnosis of ER+/HER2 metastatic Breast Cancer patient before the treatment initiation.
The selected inclusion/exclusion criteria have been set to include in the performance study appropriate population of interest, as broad as possible, but to exclude these subjects that have another current malignancy or any history of recent malignancy within 3 years.
PIK3CA kit
Prospective investigation of clinical samples for evaluation of IVD clinical performance
Healthy volunteers
In case of healthy volunteers only peripheral blood samples will be collected.
PIK3CA kit
Prospective investigation of clinical samples for evaluation of IVD clinical performance
Interventions
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PIK3CA kit
Prospective investigation of clinical samples for evaluation of IVD clinical performance
Eligibility Criteria
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Inclusion Criteria
2. Histological confirmed ER+/HER2- metastatic Breast Cancer prior to beginning a treatment
3. Life expectancy permits participation to the study.
4. Available tumor tissue sample for molecular analysis.
5. Signed informed consent form.
Exclusion Criteria
2. History of another malignancy within 3 years or current 2nd primary malignancy.
3. Patients that have not signed the informed consent.
18 Years
FEMALE
Yes
Sponsors
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University of Athens
OTHER
Pharmassist Ltd
INDUSTRY
Responsible Party
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Locations
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University General Hospital of Alexandroupoli
Alexandroupoli, Alexandroupolis, Greece
Aretaieio University Hospital of Athens
Athens, Attica, Greece
University General Hospital of Athens Attikon
Athens, Attica, Greece
Metropolital Hospital
Piraeus, Piraeus, Greece
Countries
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Other Identifiers
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CBS-PIK3CA
Identifier Type: -
Identifier Source: org_study_id