Clinical trial NCT04480814: Validation of Molecular Diagnostic Assays to Detect Cancer Biomarkers in Blood & Primary Tumor in ER+/HER2- MBC
Official title: A Clinical Performance Study to Validate the Use of Novel Molecular Diagnostic Assays for the Detection of Cancer Biomarkers in Peripheral Blood and Primary Tumor Tissue Samples of Patients With Metastatic ER+/HER2- Breast Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Keywords: Liquid biopsy
CTC
Plasma
PIK3CA
Lead sponsor: Pharmassist Ltd
Sponsor class: INDUSTRY
Collaborators: name: University of Athens
First posted: 2020-07-21
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 120 with metastatic breast cancer 30 healthy subjects

Brief summary: Conventional biopsy and surgical tumor resection are invasive procedures that capture only one instance of the progression of the tumor. However, the genome of tumor is not static, but it is constantly altered during treatment.

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: Conventional biopsy and surgical tumor resection are invasive procedures that capture only one instance of the progression of the tumor. However, the genome of tumor is not static, but it is constantly altered during treatment.

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.

Eligibility criteria: Inclusion Criteria:

1. Female aged ≥ 18 years of age.
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:

1. Female younger than 18 years old.
2. History of another malignancy within 3 years or current 2nd primary malignancy.
3. Patients that have not signed the informed consent.

Primary outcomes:
measure: Clinical performance of PIK3CA kit in CTCs, plasma and tumor tissue samples of metastatic breast cancer patients
timeFrame: 18 months
Secondary outcomes:
measure: - To study the PIK3CA Mutation Status before and after treatment of metastatic breast cancer patients using PIK3CA kit.
timeFrame: 24 months
measure: - To assess the PIK3CA Mutation Status before treatment vs treatment response of metastatic breast cancer patients using PIK3CA kit.
timeFrame: 24 months
measure: - To correlate patients' survival status with PIK3CA mutations at baseline
timeFrame: 24 months
Other outcomes:
measure: To study CK-19 expression in CTC samples
timeFrame: 24 months
measure: To study methylation status of ESR1 in CTC, ctDNA and tumor tissue samples
timeFrame: 24 months
measure: To study the presence of other biomarkers in tissue and liquid biopsy sample (at baseline).
timeFrame: 24 months
Locations:
city: Athens
country: Greece
facility: Aretaieio University Hospital of Athens
state: Attica
city: Athens
country: Greece
facility: University General Hospital of Athens Attikon
state: Attica
city: Alexandroupolis
country: Greece
facility: University General Hospital of Alexandroupoli
city: Piraeus
country: Greece
facility: Metropolital Hospital
Study officials:
References: