Selenoproteins as Prognostic Markers and Therapeutic Targets in Breast Cancer.
ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorNational Cancer Institute, Naples
About this trial
This is multicentric, spontaneous, observational, retrospective and prospective study.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
TNBC breast cancer patients, before any drug treatment
healthy women aged 25-60
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Use of immunohistochemistry investigation (IHC)
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).
Time frame
3 years2
Prospective evaluation of expression of some selenoproteins by kit ELISA in plasma samples
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.
Time frame
3 yearsSponsors and contacts
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Source ClinicalTrials.gov