Validation of Molecular Diagnostic Assays to Detect Cancer Biomarkers in Blood & Primary Tumor in ER+/HER2- MBC

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04480814
• Other study ID #: CBS-PIK3CA
• Status: Active, not recruiting
• Start date: October 11, 2019
• Est. completion date: June 11, 2023

Study information

• Verified date: March 2023
• Source: Pharmassist Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: June 11, 2023
• Est. primary completion date: May 11, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Diagnostic Test:
• PIK3CA kit
Prospective investigation of clinical samples for evaluation of IVD clinical performance

Locations

Country	Name	City	State
Greece	University General Hospital of Alexandroupoli	Alexandroupolis
Greece	Aretaieio University Hospital of Athens	Athens	Attica
Greece	University General Hospital of Athens Attikon	Athens	Attica
Greece	Metropolital Hospital	Piraeus

Sponsors (2)

Lead Sponsor	Collaborator
Pharmassist Ltd	University of Athens

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	To study CK-19 expression in CTC samples	Detection of CK-19 expression in CTCs	24 months
Other	To study methylation status of ESR1 in CTC, ctDNA and tumor tissue samples	Methylation status of ESR1 in CTC, plasma and tumor samples	24 months
Other	To study the presence of other biomarkers in tissue and liquid biopsy sample (at baseline).	Molecular profile of cancer biomarkers between tissue and peripheral blood samples	24 months
Primary	Clinical performance of PIK3CA kit in CTCs, plasma and tumor tissue samples of metastatic breast cancer patients	The performance of PIK3CA kit on detecting mutations in CTCs samples of metastatic breast cancer patients will be assessed via Sensitivity, Specificity, Positive and Negative Predictive Values, Positive and Negative Likelihood Ratios, Accuracy and Diagnostic Odds Ratio. The point of primary evaluation in CTCs samples will be at baseline and droplet digital PCR will be used as reference method.; The performance of PIK3CA kit on detecting mutations in plasma-ctDNA, and tumor tissue samples of metastatic breast cancer patients will be assessed via Sensitivity, Specificity Positive and Negative Predictive Values, Positive and Negative Likelihood Ratios, Accuracy and Diagnostic Odds Ratio. The point of primary evaluation in plasma-ctDNA and tumor tissue samples will be at baseline and therascreen PIK3CA RGQ PCR Kit will be used as reference method.	18 months
Secondary	- To study the PIK3CA Mutation Status before and after treatment of metastatic breast cancer patients using PIK3CA kit.	Presence of PIK3CA mutations at a second visit following to baseline of metastatic breast cancer patients using the PIK3CA kit.	24 months
Secondary	- To assess the PIK3CA Mutation Status before treatment vs treatment response of metastatic breast cancer patients using PIK3CA kit.	Association of PIK3CA mutations presence at baseline with clinical response to treatment (CR, PR, SD, PD) of metastatic breast cancer patients using PIK3CA kit.	24 months
Secondary	- To correlate patients' survival status with PIK3CA mutations at baseline	Metastatic breast cancer patients' survival status by presence of PIK3CA mutations at baseline.	24 months