Treg, Th17 Cells, NKT in Epithelial Ovarian Tumor

NCT03779399 | Completed DMC

• 1 other identifier: 032018
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study was to estimate the percentage and of Treg, Th17 and NKT in peripheral blood and the tissue of the epithelial ovarian tumor and relationship with blood serum level of HE4, CA125, as well as algorithm ROMA. Material and methods Mononuclear cells (PBMCs) were isolated by density gradient centrifugation obtained from peripheral blood and ovarian tissue of patient suffering ovarian pathology. Patient from control group underwent surgery for unexplanied infertility. The percentage of Treg and Th17 , NKT in peripheral blood and the tissue was assessed using the flow cytometry method according to the manufacturer's instructions. The ROMA index was calculated according to the levels of HE4 and CA-125 in serum.

Conditions

Ovarian Cancer; Borderline Ovarian Tumors; Benign Ovarian Tumor; Unexplained Infertility

Keywords

Ovarian Cancer; Borderline Ovarian Tumor; Benign Ovarian Tumor; lymphocyte T regulatory; Natural Killer T cell; ROMA; HE4

Outcome Measures

Primary Outcomes (2)

• Percentage of Treg, Th17, NKT in peripheral blood and tissue

  Percentage of regulatory TREG, Th17, NKT among peripheral blood mononuclear cells and in healthy and neoplastic tissue was made with the flow cytometry

  3 days

• Value of ROMA in serum

  Assessment level of CA125 and HE4 in serum

  3 days

Secondary Outcomes (2)

• Prognostic assessment of T reg, Th17, NKT lymphocytes in the tissue and peripheral blood of patients with ovarian cancer

  3 years

• Association between Treg, Th17,NKTand clinical marker

  1 year

Study Arms (4)

Patient with benign ovarian tumor

25 patients with benign ovarian tumor (cystadenoma) were admitted to IInd Department of Gynecology, Lublin Medical University, Lublin, Poland.

Other: Assessment of percentage of Treg, Th17, NKT and serum level of HE4, CA125 and ROMA.

Patient with borderline tumor

11 women with borderline ovarian tumor were admitted to IInd Department of Gynecology

Other: Assessment of percentage of Treg, Th17, NKT and serum level of HE4, CA125 and ROMA.

Patient with ovarian cancer

24 women with ovarian cancer were admitted to IInd Department of Gynecology

Other: Assessment of percentage of Treg, Th17, NKT and serum level of HE4, CA125 and ROMA.

Patient without ovarian pathology

20 patient with unexpleined infertility were admitted to IInd Department of Gynecology

Other: Assessment of percentage of Treg, Th17, NKT and serum level of HE4, CA125 and ROMA.

Interventions

Assessment of percentage of Treg, Th17, NKT and serum level of HE4, CA125 and ROMA. OTHER

Treg, Th17, NKT cells in peripheral blood and ovarian tissue and serum level of HE4, CA125 and ROMA.

Patient with benign ovarian tumor; Patient with borderline tumor; Patient with ovarian cancer; Patient without ovarian pathology

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: 18-75
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study group consisted of 60 women. The patients were divided into 3 subgroups: a group of 24 women with malignant epithelial ovarian tumors (cystadenocarcinomas), 25 women with benign ovarian tumors (cystadenomas) and 11 women with borderline ovarian tumors (serous borderline tumors). The control group consisted of 20 women without ovarian pathology who underwent surgery for unexplanied infertility. Patients were admitted to IInd Department of Gynecology, Lublin Medical University, Lublin, Poland, between 2011 and 2014. All women with OCs were staged III or IV according to revised 2013 FIGO classification (International Journal of Gynecology and Obstetrics, January, 2014)

You may qualify if:

• written informed consent
• age 18-75
• ovarian tumor

You may not qualify if:

• below 18 years old
• necrosis in tumor

Sponsors & Collaborators

• Medical University of Lublin: lead

Study Sites (1)

IInd Department of Gynecology

Lublin, 20-954, Poland

Location

Related Publications (1)

• Winkler I, Wos J, Bojarska-Junak A, Semczuk A, Rechberger T, Baranowski W, Markut-Miotla E, Tabarkiewicz J, Wolinska E, Skrzypczak M. An association of iNKT+/CD3+/CD161+ lymphocytes in ovarian cancer tissue with CA125 serum concentration. Immunobiology. 2020 Nov;225(6):152010. doi: 10.1016/j.imbio.2020.152010. Epub 2020 Aug 28.

  PMID: 33130518 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

peripheral blood, ovarian tissue, serum

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

CA-125 Antigen

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Mucins; Mucoproteins; Glycoproteins; Glycoconjugates; Carbohydrates; Proteins; Amino Acids, Peptides, and Proteins; Antigens, Tumor-Associated, Carbohydrate; Antigens, Neoplasm; Antigens; Biological Factors; Epitopes; Biomarkers, Tumor; Biomarkers

Study Officials

• Izabela Winkler

  Medical University of Lublin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Proffesor

Study Record Dates

• First Submitted: December 14, 2018
• First Posted: December 19, 2018
• Study Start: December 1, 2011
• Primary Completion: May 31, 2014
• Study Completion: December 31, 2016
• Last Updated: December 19, 2018

Record last verified: 2018-12

Locations

PL (1)