Selenoproteins as Prognostic Markers and Therapeutic Targets in Breast Cancer.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 300
- Locations
- 2
- Primary Endpoint
- Use of immunohistochemistry investigation (IHC)
Study Overview
Brief Summary
This is multicentric, spontaneous, observational, retrospective and prospective study.
Detailed Description
In the retrospective part of the study, Tissue Microarrays (TMA) will be prepared from surgical samples of breast tissue from a series of patients with TNBC type breast cancer.
In the prospective part of the study will be evaluated the expression of some selenoproteins by ELISA in plasma samples obtained from up to 100 healthy subjects and about 300 (~100 per year) patients with basally metastatic TNBC breast cancer (150) and metastatic (150) before any treatment.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •TNBC breast cancer patients, before any drug treatment
- •healthy women aged 25-60
Exclusion Criteria
- •donors suffering from diabetes, hypertension, active infectious states, HIV infection, Hepatitis B or C, chronic inflammatory diseases, current or previous neoplasms, heart disease or drug treatment.
Outcomes
Primary Outcomes
Use of immunohistochemistry investigation (IHC)
Time Frame: 3 years
In the retrospective part of the study, Tissue Microarrays (TMA) will be prepared from surgical samples of breast tissue from a series of patients with TNBC type breast cancer. The expression of some of the twenty-five selenoproteins will be evaluated by immunohistochemical investigation (IHC) on the TMA (Tumor Microarrays).
Prospective evaluation of expression of some selenoproteins by kit ELISA in plasma samples
Time Frame: 3 years
In the prospective part of the study will be evaluated the expression of some selenoproteins by ELISA in plasma samples obtained from up to 100 healthy subjects and about 300 (\~100 per year) patients with basally metastatic TNBC breast cancer (150) and metastatic (150) before any treatment.
Secondary Outcomes
No secondary outcomes reported