Clinical trial NCT05817227: Selenoproteins as Prognostic Markers and Therapeutic Targets in Breast Cancer.
Official title: Selenoproteins as Prognostic Markers and Therapeutic Targets in Breast Cancer.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Lead sponsor: National Cancer Institute, Naples
Sponsor class: OTHER
First posted: 2023-04-18
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
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.

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.

Eligibility criteria: 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 outcomes:
measure: Use of immunohistochemistry investigation (IHC)
timeFrame: 3 years
measure: Prospective evaluation of expression of some selenoproteins by kit ELISA in plasma samples
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori - Fondazione "G.Pascale", IRCCS
city: Roma
country: Italy
facility: Istituto Nazionale Tumori Regina Elena
Study officials:
affiliation: IRCCS I.N.T. "G. Pascale"
name: Alfredo Budillon, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: IRCCS I.N.T. "G. Pascale"
name: Susan Costantini, PhD
role: PRINCIPAL_INVESTIGATOR
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