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Investigation Of Receptivity Markers For Endometrial Cancer Treatment Development

Sponsor
Celal Bayar University (Other)
Overall Status
Completed
CT.gov ID
NCT05914844
Collaborator
(none)
30
Enrollment
1
Location
14.4
Actual Duration (Months)
2.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Hyaluronan is an extracellular matrix protein that is involved in cell-cell and cell-matrix interactions. Hyaluronan performs this activity through hyaladherins, which are intracellular and extracellular receptors.

The purpose of this study was to compare the distributions of Hyaluronan Synthetase 2 (HAS2) and CD44s in healthy endometrial tissue samples obtained during the proliferative phase endometrium (PPE) and secretory phase endometrium (SPE), as well as pathologic samples diagnosed with benign endometrial hyperplasia (EH), endometrial intraepithelial neoplasia (EIN), early stage of endometrial carcinoma (EC) (stage I/II) and advanced stage of endometrial carcinoma (stage III/IV) (n:5, each).

By using the avidin-biotin-peroxidase method, tissue samples that had been fixed with formalin passed through a regular paraffin follow-up protocol, and subsequently embedded in paraffin were stained indirectly with anti-CD44s and anti-HAS2 primary antibodies.

Immunostaining intensity was graded as 0: negative, 1: weak, 2: moderate, 3: strong, and 4:

very strong using a semiquantitative technique. The ANOVA test was used to assess the statistical significance of the findings. Statistical significance was defined as (p) values less than 0.05.

While weak HAS2 and weak/moderate CD44s immunoreactivity was observed on the surface epithelium (SE)/glandular epithelium (GE) and stroma of the tissue samples acquired during PPE; weak/moderate HAS2 and moderate CD44s immunoreactivity were observed in SPE and EH groups; moderate/strong HAS2, strong CD44s immunoreactivity was observed in EIN; strong/very strong HAS2 and very strong CD44s immunoreactivity were observed in early-stage EC and advanced stage EC. It was determined that the immunoreactivity intensity increased at a statistically significant level in both early and advanced stage EC.

The fact that HAS2 and CD44s, two intracellular receptors, have increased in endometrial carcinoma leads us to believe that they are likely to play a role in tumor development, invasion, migration, metastasis and that they may be useful in developing future treatment protocols targeting hyaluronan receptors.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    30 participants
    Observational Model:
    Case-Crossover
    Time Perspective:
    Prospective
    Official Title:
    The Role Of Hyaluronan Receptor Cd44s And Has2 In Endometrial Malignities
    Actual Study Start Date :
    Nov 19, 2021
    Actual Primary Completion Date :
    Aug 17, 2022
    Actual Study Completion Date :
    Feb 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Group 1:

    Proliferative phase endometrium (PPE)
    Group 2:

    Secretory phase endometrium
    Group 3:

    Benign endometrial hyperplasia
    Group 4:

    Endometrial intraepithelial neoplasia
    Group 5:

    Early stage of endometrial carcinoma
    Group6:

    Advanced stage of endometrial carcinoma

    Outcome Measures

    Primary Outcome Measures

    1. Investigation Of Receptivity Markers For Endometrial Cancer Treatment Development [Baseline]

      The increase or decrease of hyaluronan receptors, which play a role in endometrial cancer, has a critical role to be explained in cancer treatments.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • All patients with endometrial carcinoma underwent surgery.
    Exclusion Criteria:
    • No patient was subject to chemotherapy or radiotherapy prior to surgery.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Manisa Celal Bayar University Yunusemre Manì‡sa Turkey 45030

    Sponsors and Collaborators

    • Celal Bayar University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hayrunnisa Yesil Sarsmaz, Asistant Prof., Celal Bayar University
    ClinicalTrials.gov Identifier:
    NCT05914844
    Other Study ID Numbers:
    • MCBU_endometriumcancer
    First Posted:
    Jun 22, 2023
    Last Update Posted:
    Jun 22, 2023
    Last Verified:
    Jun 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Hayrunnisa Yesil Sarsmaz, Asistant Prof., Celal Bayar University
    endometrial carcinoma
    immunohistochemistry
    CD44s
    HAS2
    Additional relevant MeSH terms:
    Endometrial Neoplasms

    Study Results

    No Results Posted as of Jun 22, 2023