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Clinical Trials in Italy / NCT05817227
Recruiting Observational

Selenoproteins as Prognostic Markers and Therapeutic Targets in Breast Cancer.

NCT05817227 · tracked via the Priya Life Science Italy tracker
Sponsor
National Cancer Institute, Naples
Phase
Observational
Started
2022-05-19
Last updated
2025-12-22

Condition(s) studied

Breast Cancer

Study summary

This is multicentric, spontaneous, observational, retrospective and prospective study.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

  • 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.

Trial sites (2)

FacilityCityRegionStatus
Istituto Nazionale Tumori - Fondazione "G.Pascale", IRCCS Naples Napoli Recruiting
Istituto Nazionale Tumori Regina Elena Roma Roma Recruiting

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Other trials for the same condition

TACTIVE-U: A Study to Learn About the Study Medicine (Vepdegestrant) When Given With Other Medicines in People With Advanced or Metastatic Breast Cancer (Sub-Study A) Active, not recruiting
The OPBC-07/microNAC Study Active, not recruiting
Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2) Recruiting
Vocational Rehabilitation for the Return to Work of Breast Cancer Patients: a Feasibility Study Active, not recruiting
Music Therapy in Patients With Breast Cancer (IMPACT) Enrolling by invitation
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05817227 on ClinicalTrials.gov ↗ ← All trials in Italy