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NCT05817227 Clinical Trial

Selenoproteins as Prognostic Markers and Therapeutic Targets in Breast Cancer.

Breast Cancer Clinical Trial

— Selebrec  

Official title:
Selenoproteins as Prognostic Markers and Therapeutic Targets in Breast Cancer.

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05817227
Other study ID # SELEBREC
Secondary ID 57/21oss
Status Recruiting
Phase
First received
Last updated
Start date May 19, 2022
Est. completion date November 19, 2025

Study information
Verified date June 2024
Source National Cancer Institute, Naples
Contact Elena Di Gennaro, PhD
Phone 08117770584
Email e.digennaro@istitutotumori.na.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 300
Est. completion date November 19, 2025
Est. primary completion date November 19, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
Italy Istituto Nazionale Tumori - Fondazione "G.Pascale", IRCCS Napoli
Italy Istituto Nazionale Tumori Regina Elena Roma

Sponsors (1)
Lead Sponsor Collaborator
National Cancer Institute, Naples

Country where clinical trial is conducted

Italy, 

References & Publications (22)

Avery JC, Hoffmann PR. Selenium, Selenoproteins, and Immunity. Nutrients. 2018 Sep 1;10(9):1203. doi: 10.3390/nu10091203. — View Citation

Capone F, Polo A, Sorice A, Budillon A, Costantini S. Integrated Analysis to Study the Relationship between Tumor-Associated Selenoproteins: Focus on Prostate Cancer. Int J Mol Sci. 2020 Sep 13;21(18):6694. doi: 10.3390/ijms21186694. — View Citation

Cha MK, Suh KH, Kim IH. Overexpression of peroxiredoxin I and thioredoxin1 in human breast carcinoma. J Exp Clin Cancer Res. 2009 Jun 30;28(1):93. doi: 10.1186/1756-9966-28-93. — View Citation

Costantini S, Capone F, Polo A, Bagnara P, Budillon A. Valosin-Containing Protein (VCP)/p97: A Prognostic Biomarker and Therapeutic Target in Cancer. Int J Mol Sci. 2021 Sep 21;22(18):10177. doi: 10.3390/ijms221810177. — View Citation

Debski MG, Pachucki J, Ambroziak M, Olszewski W, Bar-Andziak E. Human breast cancer tissue expresses high level of type 1 5'-deiodinase. Thyroid. 2007 Jan;17(1):3-10. doi: 10.1089/thy.2006.0012. — View Citation

DeSantis CE, Ma J, Gaudet MM, Newman LA, Miller KD, Goding Sauer A, Jemal A, Siegel RL. Breast cancer statistics, 2019. CA Cancer J Clin. 2019 Nov;69(6):438-451. doi: 10.3322/caac.21583. Epub 2019 Oct 2. — View Citation

Epplein M, Burk RF, Cai Q, Hargreaves MK, Blot WJ. A prospective study of plasma Selenoprotein P and lung cancer risk among low-income adults. Cancer Epidemiol Biomarkers Prev. 2014 Jul;23(7):1238-44. doi: 10.1158/1055-9965.EPI-13-1308. Epub 2014 Apr 24. — View Citation

Garrido-Castro AC, Lin NU, Polyak K. Insights into Molecular Classifications of Triple-Negative Breast Cancer: Improving Patient Selection for Treatment. Cancer Discov. 2019 Feb;9(2):176-198. doi: 10.1158/2159-8290.CD-18-1177. Epub 2019 Jan 24. — View Citation

Guariniello S, Di Bernardo G, Colonna G, Cammarota M, Castello G, Costantini S. Evaluation of the selenotranscriptome expression in two hepatocellular carcinoma cell lines. Anal Cell Pathol (Amst). 2015;2015:419561. doi: 10.1155/2015/419561. Epub 2015 Jun 23. — View Citation

Hu YJ, Diamond AM. Role of glutathione peroxidase 1 in breast cancer: loss of heterozygosity and allelic differences in the response to selenium. Cancer Res. 2003 Jun 15;63(12):3347-51. — View Citation

Knight JA, Onay UV, Wells S, Li H, Shi EJ, Andrulis IL, Ozcelik H. Genetic variants of GPX1 and SOD2 and breast cancer risk at the Ontario site of the Breast Cancer Family Registry. Cancer Epidemiol Biomarkers Prev. 2004 Jan;13(1):146-9. doi: 10.1158/1055-9965.epi-03-0164. — View Citation

Lopez-Saez JB, Senra-Varela A, Pousa-Estevez L. Selenium in breast cancer. Oncology. 2003;64(3):227-31. doi: 10.1159/000069312. — View Citation

Lu J, Holmgren A. Selenoproteins. J Biol Chem. 2009 Jan 9;284(2):723-7. doi: 10.1074/jbc.R800045200. Epub 2008 Aug 29. — View Citation

Marciel MP, Hoffmann PR. Selenoproteins and Metastasis. Adv Cancer Res. 2017;136:85-108. doi: 10.1016/bs.acr.2017.07.008. Epub 2017 Sep 1. — View Citation

Nunziata C, Polo A, Sorice A, Capone F, Accardo M, Guerriero E, Marino FZ, Orditura M, Budillon A, Costantini S. Structural analysis of human SEPHS2 protein, a selenocysteine machinery component, over-expressed in triple negative breast cancer. Sci Rep. 2019 Nov 6;9(1):16131. doi: 10.1038/s41598-019-52718-0. — View Citation

Pellatt AJ, Wolff RK, John EM, Torres-Mejia G, Hines LM, Baumgartner KB, Giuliano AR, Lundgreen A, Slattery ML. SEPP1 influences breast cancer risk among women with greater native american ancestry: the breast cancer health disparities study. PLoS One. 2013 Nov 20;8(11):e80554. doi: 10.1371/journal.pone.0080554. eCollection 2013. — View Citation

Ravn-Haren G, Olsen A, Tjonneland A, Dragsted LO, Nexo BA, Wallin H, Overvad K, Raaschou-Nielsen O, Vogel U. Associations between GPX1 Pro198Leu polymorphism, erythrocyte GPX activity, alcohol consumption and breast cancer risk in a prospective cohort study. Carcinogenesis. 2006 Apr;27(4):820-5. doi: 10.1093/carcin/bgi267. Epub 2005 Nov 14. — View Citation

Rusolo F, Capone F, Pasquale R, Angiolillo A, Colonna G, Castello G, Costantini M, Costantini S. Comparison of the seleno-transcriptome expression between human non-cancerous mammary epithelial cells and two human breast cancer cell lines. Oncol Lett. 2017 Apr;13(4):2411-2417. doi: 10.3892/ol.2017.5715. Epub 2017 Feb 13. — View Citation

Short SP, Williams CS. Selenoproteins in Tumorigenesis and Cancer Progression. Adv Cancer Res. 2017;136:49-83. doi: 10.1016/bs.acr.2017.08.002. — View Citation

Siegel RL, Miller KD, Jemal A. Cancer statistics, 2019. CA Cancer J Clin. 2019 Jan;69(1):7-34. doi: 10.3322/caac.21551. Epub 2019 Jan 8. — View Citation

Varlamova EG. Participation of selenoproteins localized in the ER in the processes occurring in this organelle and in the regulation of carcinogenesis-associated processes. J Trace Elem Med Biol. 2018 Jul;48:172-180. doi: 10.1016/j.jtemb.2018.04.005. Epub 2018 Apr 3. — View Citation

Yu SS, Du JL. Selenoprotein S: a therapeutic target for diabetes and macroangiopathy? Cardiovasc Diabetol. 2017 Aug 10;16(1):101. doi: 10.1186/s12933-017-0585-8. — View Citation

* Note: There are 22 references in all — Click here to view all references

Outcome
Type Measure Description Time frame Safety issue
Primary 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). 3 years
Primary 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. 3 years
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