Endometrium CancerNCT04603599
Relationship of Endometrial Cancer and Serum Soluble L1CAM Level
An observational study of Endometrium Cancer, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to evaluate the effect of serum soluble L1CAM (sL1CAM) on the diagnosis and prognosis of endometrial cancer. This prospective randomized controlled trial will be conducted in patients who have undergone endometrial biopsy and whose pathology results are reported as benign endometrial changes… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrium Cancer
- What is being tested?
- serum soluble L1CAM (sL1CAM)
- How many people
- 146 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2019to 31 Dec 2019
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: benign endometrial changes, endometrial hyperplasia or endometrial cancer
Who may be able to join
- Patients who underwent endometrial biopsy due to abnormal uterine bleeding and whose pathology results were reported as benign endometrial changes, endometrial hyperplasia or endometrial cancer were included in the study. All patients participating in the study signed informed consent.
Who cannot join
- Patients who did not have consent, received neoadjuvant therapy and who would not have surgery despite endometrial cancer were excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to evaluate the effect of serum soluble L1CAM (sL1CAM) on the diagnosis and prognosis of endometrial cancer. This prospective randomized controlled trial will be conducted in patients who have undergone endometrial biopsy and whose pathology results are reported as benign endometrial changes, endometrial hyperplasia, or endometrial cancer. The sL1CAM level between groups will be compared. The relationship between prognostic factors and serum sL1CAM will be evaluated in patients with endometrial cancer.
- Conditions
- Endometrium Cancer
- Being tested
- serum soluble L1CAM (sL1CAM)
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serum soluble L1CAM (sL1CAM)Diagnostic test
blood sample
| Study group | Role | What they receive |
|---|---|---|
| benign endometrial changes | Not described Receives: Diagnostic Test: serum soluble L1CAM (sL1CAM) | |
| endometrial hyperplasia | Not described Receives: Diagnostic Test: serum soluble L1CAM (sL1CAM) | |
| endometrial cancer | Not described Receives: Diagnostic Test: serum soluble L1CAM (sL1CAM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum sL1CAM level
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2020
- Study start1 Jan 2019
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrium CancerStudies 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Dermir, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04603599
- Sponsor's protocol ID
- Merve L1CAM
- Status last verified
- Oct 2020
- First submitted
- 14 Oct 2020
- Last updated
- 2 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship of Endometrial Cancer and Serum Soluble L1CAM Level
- ClinicalTrials.gov ID
- NCT04603599
- Acronym / sponsor ID
- Merve L1CAM
- Conditions
- Endometrium Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 27 Oct 2020 (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.
The aim of this study is to evaluate the effect of serum soluble L1CAM (sL1CAM) on the diagnosis and prognosis of endometrial cancer. This prospective randomized controlled trial will be conducted in patients who have undergone endometrial biopsy and whose pathology results are reported as benign endometrial changes, endometrial hyperplasia, or endometrial cancer. The sL1CAM level between groups will be compared. The relationship between prognostic factors and serum sL1CAM will be evaluated in patients with endometrial cancer.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| benign endometrial changes | – | Diagnostic Test: serum soluble L1CAM (sL1CAM) |
| endometrial hyperplasia | – | Diagnostic Test: serum soluble L1CAM (sL1CAM) |
| endometrial cancer | – | Diagnostic Test: serum soluble L1CAM (sL1CAM) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- benign endometrial changes, endometrial hyperplasia or endometrial cancer
Key inclusion criteria (1 listed)
- Patients who underwent endometrial biopsy due to abnormal uterine bleeding and whose pathology results were reported as benign endometrial changes, endometrial hyperplasia or endometrial cancer were included in the study. All patients participating in the study signed informed consent.
Key exclusion criteria (1 listed)
- Patients who did not have consent, received neoadjuvant therapy and who would not have surgery despite endometrial cancer were excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| serum soluble L1CAM (sL1CAM)blood sample | Diagnostic test | benign endometrial changes, endometrial cancer, endometrial hyperplasia |
Primary outcome
serum sL1CAM level
Time frame: one year
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 2 Nov 2020.
- Individual participant dataSharing planned: Undecided
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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 Endometrium Cancer, run by Kocaeli 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 2 Nov 2020. 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?
serum sL1CAM level (time frame: one year). 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 2 Nov 2020.