Identification and Characterization of Commercial RUO Antibodies for the Detection of Specific Breast Cancer Tumoral Markers Expressed in Potential Circulating Tumoral Cells (CTCs)
Overview
- Phase
- Not Applicable
- Intervention
- Early Breast Cancer patients
- Conditions
- Breast Neoplasms
- Sponsor
- Tethis S.p.A.
- Enrollment
- 84
- Locations
- 1
- Primary Endpoint
- Number of commercial Antibodies capable of Identify specific Breast Cancer Biomarkers
- Status
- Active, not recruiting
- Last Updated
- 2 months ago
Overview
Brief Summary
This is an exploratory research study with the aim of identifying specific cancer biomarkers in various subtypes of breast cancer. Blood samples will be collected from 60 participants divided into 40 patients and 20 healthy donors. An amendment to the research has been proposed to enroll 24 additional participants divided into 12 patients and 12 healthy donors.
Detailed Description
In this research study different commercial RUO (Research Use Only) antibodies will be purchased and then tested on blood samples obtained by participants affected by breast cancer and by healthy participants as control. Sixty participants will be enrolled belonging to different categories: 20 participants affected by early breast cancer, 20 participants affected by metastatic breast cancer, and 20 healthy volunteers to be used as negative control. After signing the informed consent form, participants will be screened to evaluate if they meet the eligibility criteria. If all the criteria are met, participants will be enrolled into the study and will be asked to provide some demographic and other data. A 13 ml blood sample will be collected by the subjects and shipped to Tethis laboratories in order to be processed and analysed. An amendment has been proposed to enroll 24 additional participants divided into 12 patients and 12 healthy donors. During the amendment, participants will be enrolled to test the analytical capacity of the antibodies evaluated in the first part on samples processed with different methods in order to select the optimal one for future development.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Participant is willing and able to give and sign a written informed consent for participation in the study.
- •Female aged 18 years or above.
- •Diagnosed with early breast cancer (stage I and II) or metastatic breast cancer.
- •Healthy participants who visit the site for reason other than cancer diagnosis (including breast cancer).
Exclusion Criteria
- •History of other malignancies other than breast cancer (for healthy participants includes also breast cancer).
- •Undergone surgery or treatment for breast cancer before enrollment (only for early breast cancer).
- •Presence of known severe coagulation or haematological disorder
- •Known Pregnancy
- •Absence of written signed informed consent for participation in the study
Arms & Interventions
Early Breast Cancer patients
Early stage breast cancer category is based on the definition of the European Society of medical Oncology and is defined as disease confined to the breast with or without regional lymph node involvement
Metastatic Breast Cancer patients
Metastatic breast cancer category is based on the definition of the European Society of Medical Oncology and is defined as disease spread to other parts of the body, such as bones, liver or lungs (also called stage IV). Tumours at distant sites are called metastases.
Healthy donors
Participants who are in good health and without history of cancer disease
Outcomes
Primary Outcomes
Number of commercial Antibodies capable of Identify specific Breast Cancer Biomarkers
Time Frame: 1 day (at the blood draw)
Qualitative Assessment of Staining Positivity for different Breast Cancer Biomarkers