Identification of Breast Cancer Specific Markers in Patients Compared to Healthy Participants

Tethis

Status: Active, not recruiting

Conditions: Breast Neoplasms

Study type: Observational

Funder types: Industry

Identifiers

NCT05054010

TET-21-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 84 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

84 participants in 3 patient groups

Early Breast Cancer patients

Description:

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

Description:

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

Description:

Participants who are in good health and without history of cancer disease