Selenoproteins as Prognostic Markers and Therapeutic Targets in Breast Cancer.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05817227

Acronym

Selebrec

Enrollment

300

Registered

2023-04-18

Start date

2022-05-19

Completion date

2027-11-19

Last updated

2025-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Use of immunohistochemistry investigation (IHC)	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	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.

Countries

Italy

Contacts

Primary ContactElena Di Gennaro, PhD

e.digennaro@istitutotumori.na.it08117770584

Backup ContactSusan Costantini, PhD

s.costantini@istitutotumori.na.it08251911729

Outcome results