Endometrial CancerPhase 2NCT02560571
Pre-operative Studies for Prediction of Lymph Nodes Involvement in Endometrial Cancer Patients
A Phase 2 study testing ultrasound and blood test in people with Endometrial Cancer, run by Meir Medical Center at 1 site in Israel.
Trial summary
The study evaluates pre-operative prediction of the risk for lymph nodes involvement in endometrial cancer patients. Patients will undergo ultrasound exam (bi and three dimensional) and biomarker test - Ca 125, in addition to routine physical and laboratory exams, before surgery. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- ultrasound and blood test
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2015to Oct 2020
- Phase
- Phase 2
- 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
Who may be able to join
- Endometrial cancer patients
- Surgical candidates
Who cannot join
- Fertility preservation therapy
- Contraindication for surgery
- Stage 2 and higher
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preoperative Evaluation of Endometrial Cancer
The study evaluates pre-operative prediction of the risk for lymph nodes involvement in endometrial cancer patients. Patients will undergo ultrasound exam (bi and three dimensional) and biomarker test - Ca 125, in addition to routine physical and laboratory exams, before surgery.
The sonographic evaluation will include endometrial characteristics and myometrial invasion, pelvic findings and enlarged lymph nodes.
- Conditions
- Endometrial Cancer
- Being tested
- ultrasound, blood test
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasoundDevice
blood testOther
| Study group | Role | What they receive |
|---|---|---|
| all patients | Experimental | all study patients will undergo ultrasound and blood test Receives: Device: ultrasound; Other: blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of participants with positive nodes
Measured: 4 weeks after surgery (4-6 weeks from enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2015 (estimated)
- Study startOct 2015
- Primary completionOct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yfat kadan, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02560571
- Sponsor's protocol ID
- 0142-15-MMC
- Status last verified
- Sep 2016
- First submitted
- 21 Sep 2015
- Last updated
- 20 Sep 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Evaluation of Endometrial Cancer
- ClinicalTrials.gov ID
- NCT02560571
- Acronym / sponsor ID
- 0142-15-MMC
- Conditions
- Endometrial Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Oct 2020 (estimated)
- First posted
- 25 Sep 2015 (estimated)
- 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 study evaluates pre-operative prediction of the risk for lymph nodes involvement in endometrial cancer patients. Patients will undergo ultrasound exam (bi and three dimensional) and biomarker test - Ca 125, in addition to routine physical and laboratory exams, before surgery.
The sonographic evaluation will include endometrial characteristics and myometrial invasion, pelvic findings and enlarged lymph nodes.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| all patients | Experimental | Device: ultrasound, Other: blood testall study patients will undergo ultrasound and blood test |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Endometrial cancer patients
- Surgical candidates
Key exclusion criteria (3 listed)
- Fertility preservation therapy
- Contraindication for surgery
- Stage 2 and higher
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 |
|---|---|---|
| ultrasound | Device | all patients |
| blood test | Other | all patients |
Primary outcome
number of participants with positive nodes
Time frame: 4 weeks after surgery (4-6 weeks from enrollment)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2016.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ultrasound and blood test in people with Endometrial Cancer, run by Meir Medical Center at 1 site in Israel.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 20 Sep 2016. 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 Israel. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact yfat kadan, md (972-9-7471575, yfat_ka@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of participants with positive nodes (time frame: 4 weeks after surgery (4-6 weeks from enrollment)). 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 20 Sep 2016.