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Trial Title:
Selenoproteins as Prognostic Markers and Therapeutic Targets in Breast Cancer.
NCT ID:
NCT05817227
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Other
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Istituto Nazionale Tumori - Fondazione "G.Pascale", IRCCS
Address:
City:
Napoli
Zip:
80131
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Alfredo Budillon, M.D.
Phone:
0815903756
Email:
a.budillon@istitutotumori.na.it
Contact backup:
Last name:
Susan Costantini, PhD
Phone:
08251911729
Email:
s.costantini@istitutotumori.na.it
Facility:
Name:
Istituto Nazionale Tumori Regina Elena
Address:
City:
Roma
Zip:
00144
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Patrizia Vici, M.D.
Phone:
0652665584
Email:
patrizia.vici@ifo.it
Start date:
May 19, 2022
Completion date:
November 19, 2025
Lead sponsor:
Agency:
National Cancer Institute, Naples
Agency class:
Other
Source:
National Cancer Institute, Naples
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05817227
