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NCT Number: NCT05817227

Selenoproteins as Prognostic Markers and Therapeutic Targets in Breast Cancer.

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

Recruiting

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Istituto Nazionale Tumori - Fondazione "G.Pascale", IRCCS, Naples, Napoli, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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).

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Elena Di Gennaro, PhD

CONTACT

[email protected]

08117770584

Susan Costantini, PhD

CONTACT

[email protected]

08251911729

Sponsors and collaborators

Lead sponsor

National Cancer Institute, Naples

Other

Registry information

Acronym: Selebrec

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Apr 18, 2023
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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