Endometrial Cancer StageNCT05914844
Investigation Of Receptivity Markers For Endometrial Cancer Treatment Development
An observational study of Endometrial Cancer Stage, run by Manisa Celal Bayar University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Endometrial Cancer Stage
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Nov 2021to 1 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with endometrium cancer
Who may be able to join
- All patients with endometrial carcinoma underwent surgery.
Who cannot join
- No patient was subject to chemotherapy or radiotherapy prior to surgery.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Manisa Celal Bayar University
Yunusemre, Mani̇sa, 45030
About this study
Official title: The Role Of Hyaluronan Receptor Cd44s And Has2 In Endometrial Malignities
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).
Read more
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.
- Conditions
- Endometrial Cancer Stage
- Keywords
- endometrial carcinoma, immunohistochemistry, CD44s, HAS2
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start19 Nov 2021
- Primary completion17 Aug 2022
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial Cancer StageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manisa Celal Bayar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hayrunnisa Yesil Sarsmaz, Manisa Celal Bayar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05914844
- Sponsor's protocol ID
- MCBU_endometriumcancer
- Status last verified
- Jun 2023
- First submitted
- 2 Dec 2022
- Last updated
- 22 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role Of Hyaluronan Receptor Cd44s And Has2 In Endometrial Malignities
- ClinicalTrials.gov ID
- NCT05914844
- Acronym / sponsor ID
- MCBU_endometriumcancer
- Conditions
- Endometrial Cancer Stage
- Keywords
- endometrial carcinoma, immunohistochemistry, CD44s, HAS2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Manisa Celal Bayar UniversityUniversity, hospital or other
- Study start
- 19 Nov 2021 (actual)
- Primary completion
- 17 Aug 2022 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 22 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with endometrium cancer
Key inclusion criteria (1 listed)
- All patients with endometrial carcinoma underwent surgery.
Key exclusion criteria (1 listed)
- No patient was subject to chemotherapy or radiotherapy prior to surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Investigation Of Receptivity Markers For Endometrial Cancer Treatment Development
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometrial Cancer Stage, run by Manisa Celal Bayar University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigation Of Receptivity Markers For Endometrial Cancer Treatment Development (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.