Selenoproteins as Prognostic Markers and Therapeutic Targets in Breast Cancer. (Selebrec)

December 16, 2025 updated by: National Cancer Institute, Naples
This is multicentric, spontaneous, observational, retrospective and prospective study.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
    • Napoli
    • Roma
      • Roma, Roma, Italy, 00144
        • Recruiting
        • Istituto Nazionale Tumori Regina Elena
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The patients included in the study are all women and have an age below 40 in 26/235 (11.1%) cases, between 40 and 60 in 108/235 (46.0%) cases and over 60 for 101/235 (43.0%) cases.

Tumours have the following clinical and pathological characteristics: 204/235 (86.8%) are carcinomiducts and 31/235 (13.2%) are non ductal carcinomas; 202/235 (86%) grade 3, 31/235 (13.1%) grade 2 and 2/235 (0.9%) grade 1; tumour dimensions are less than 2 cm (T1) in 103/225 cases (45.8%), between 2 and 5 cm in 103/225 (45.8%) and greater than 5 cm in 19/225 (8.4%). Expression of Ki67 diproliferation factor was high (>20%) in 186/227 (81.9%) patients and low (<20%) in 41/227 (18.1%). At the date of surgery 97/232 (41.8%) patients had lymphonode metastases, while 44/111 (39.6%) had distant metastases.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
3 years
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.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute, Naples

Investigators

  • Principal Investigator: Alfredo Budillon, M.D., IRCCS I.N.T. "G. Pascale"
  • Principal Investigator: Susan Costantini, PhD, IRCCS I.N.T. "G. Pascale"

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 19, 2022

Primary Completion (Estimated)

November 19, 2027

Study Completion (Estimated)

November 19, 2027

Study Registration Dates

First Submitted

March 22, 2023

First Submitted That Met QC Criteria

April 4, 2023

First Posted (Actual)

April 18, 2023

Study Record Updates

Last Update Posted (Actual)

December 22, 2025

Last Update Submitted That Met QC Criteria

December 16, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SELEBREC
  • 57/21oss (Other Identifier: IRCCS I.N.T. "G. Pascale")

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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