NCT05914844

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 19, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 17, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 2, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
5 months until next milestone

First Posted

Study publicly available on registry

June 22, 2023

Completed
Last Updated

June 22, 2023

Status Verified

June 1, 2023

Enrollment Period

9 months

First QC Date

December 2, 2022

Last Update Submit

June 13, 2023

Conditions

Keywords

endometrial carcinomaimmunohistochemistryCD44sHAS2

Outcome Measures

Primary Outcomes (1)

  • Investigation Of Receptivity Markers For Endometrial Cancer Treatment Development

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

    Baseline

Study Arms (6)

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

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with endometrium cancer

You may qualify if:

  • \- All patients with endometrial carcinoma underwent surgery.

You may not qualify if:

  • No patient was subject to chemotherapy or radiotherapy prior to surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Manisa Celal Bayar University

Yunusemre, Mani̇sa, 45030, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITH DNA

endometrial tissue cells

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asistant Prof.

Study Record Dates

First Submitted

December 2, 2022

First Posted

June 22, 2023

Study Start

November 19, 2021

Primary Completion

August 17, 2022

Study Completion

February 1, 2023

Last Updated

June 22, 2023

Record last verified: 2023-06

Locations