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Treg, Th17 Cells, NKT in Epithelial Ovarian Tumor

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ClinicalTrials.gov Identifier: NCT03779399
Recruitment Status : Completed
First Posted : December 18, 2018
Last Update Posted : December 18, 2018
Sponsor:
Information provided by (Responsible Party):
Paweł Miotła, Medical University of Lublin

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.


Condition or disease Intervention/treatment
Ovarian Cancer Borderline Ovarian Tumors Benign Ovarian Tumor Unexplained Infertility Other: Assessment of percentage of Treg, Th17, NKT and serum level of HE4, CA125 and ROMA.

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Lymphocyte T Regulatory , Th17 and NKT in Epithelial Ovarian Tumor- Prognostic Assessment and Relationship With Clinical Marker
Actual Study Start Date : December 1, 2011
Actual Primary Completion Date : May 31, 2014
Actual Study Completion Date : December 31, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Group/Cohort Intervention/treatment
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.
Treg, Th17, NKT cells in peripheral blood and ovarian tissue 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.
Treg, Th17, NKT cells in peripheral blood and ovarian tissue 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.
Treg, Th17, NKT cells in peripheral blood and ovarian tissue 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.
Treg, Th17, NKT cells in peripheral blood and ovarian tissue and serum level of HE4, CA125 and ROMA.




Primary Outcome Measures :
  1. Percentage of Treg, Th17, NKT in peripheral blood and tissue [ Time Frame: 3 days ]
    Percentage of regulatory TREG, Th17, NKT among peripheral blood mononuclear cells and in healthy and neoplastic tissue was made with the flow cytometry

  2. Value of ROMA in serum [ Time Frame: 3 days ]
    Assessment level of CA125 and HE4 in serum


Secondary Outcome Measures :
  1. Prognostic assessment of T reg, Th17, NKT lymphocytes in the tissue and peripheral blood of patients with ovarian cancer [ Time Frame: 3 years ]
    Kaplan-Meier survival analysis was performed in the group of patients with ovarian cancer.

  2. Association between Treg, Th17,NKTand clinical marker [ Time Frame: 1 year ]
    Spearman's rank correlation coefficient and its significance test was applied to assess relationships between two parameters.


Biospecimen Retention:   Samples With DNA
peripheral blood, ovarian tissue, serum


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   18-75
Accepts Healthy Volunteers:   Yes
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)
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • below 18 years old
  • necrosis in tumor

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03779399


Locations
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Poland
IInd Department of Gynecology
Lublin, Poland, 20-954
Sponsors and Collaborators
Medical University of Lublin
Investigators
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Principal Investigator: Izabela Winkler Medical University of Lublin

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Responsible Party: Paweł Miotła, Clinical Proffesor, Medical University of Lublin
ClinicalTrials.gov Identifier: NCT03779399     History of Changes
Other Study ID Numbers: 032018
First Posted: December 18, 2018    Key Record Dates
Last Update Posted: December 18, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Paweł Miotła, Medical University of Lublin:
Ovarian Cancer
Borderline Ovarian Tumor
Benign Ovarian Tumor
lymphocyte T regulatory
Natural Killer T cell
ROMA
HE4
Additional relevant MeSH terms:
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Ovarian Neoplasms
Infertility
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Genital Diseases, Male