Malignant Tumor of Women's Reproductive SystemNCT03598335
Characterizing Malignant Tumors Using Ultrasound Doppler Imaging
An observational study of Malignant Tumor of Women's Reproductive System, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
The aim of this study is to determine whether Ultrasound Doppler imaging can identify malignant tumors at a very early stage. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Malignant Tumor of Women's Reproductive System
- What is being tested?
- Ultrasound
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2018to Jul 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 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women presenting at the Hillel Yaffe Medical Center gynecological ultrasound clinic.
Who may be able to join
- Women presenting for routine abdominal/vaginal ultrasound
Who cannot join
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to determine whether Ultrasound Doppler imaging can identify malignant tumors at a very early stage.
- Being tested
- Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDevice
Ultrasound imaging of women arriving at clinic for routine care
| Study group | Role | What they receive |
|---|---|---|
| Women with malignant tumor | Women with malignant tumor in reproductive system Receives: Device: Ultrasound | |
| Women with benign tumor | Women with benign tumor in reproductive system Receives: Device: Ultrasound | |
| Women with no observed tumor | Women with no observed tumor in reproductive system Receives: Device: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early characterization of malignant tumors
Comparison of Ultrasound Doppler findings at different speeds between women without tumors, with benign tumors and with malignant tumors of reproductive system
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 posted26 Jul 2018
- Study startJul 2018 (estimated)
- Primary completionJul 2019 (estimated)
- Study completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Tumor of Women's Reproductive SystemStudies 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
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Alon Shrim, MD, Principal investigator, Hillel Yaffe Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03598335
- Sponsor's protocol ID
- HYMC-0096-17
- Status last verified
- Jul 2018
- First submitted
- 16 Jul 2018
- Last updated
- 26 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterizing Malignant Tumors Using Ultrasound Doppler Imaging
- ClinicalTrials.gov ID
- NCT03598335
- Acronym / sponsor ID
- HYMC-0096-17
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Jul 2018 (estimated)
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 26 Jul 2018 (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 determine whether Ultrasound Doppler imaging can identify malignant tumors at a very early stage.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Women with malignant tumor | – | Device: UltrasoundWomen with malignant tumor in reproductive system |
| Women with benign tumor | – | Device: UltrasoundWomen with benign tumor in reproductive system |
| Women with no observed tumor | – | Device: UltrasoundWomen with no observed tumor in reproductive system |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women presenting at the Hillel Yaffe Medical Center gynecological ultrasound clinic.
Key inclusion criteria (1 listed)
- Women presenting for routine abdominal/vaginal ultrasound
Key exclusion criteria (1 listed)
- Pregnant women
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 |
|---|---|---|
| UltrasoundUltrasound imaging of women arriving at clinic for routine care | Device | Women with benign tumor, Women with malignant tumor, Women with no observed tumor |
Primary outcome
Early characterization of malignant tumors
Time frame: One year
Comparison of Ultrasound Doppler findings at different speeds between women without tumors, with benign tumors and with malignant tumors of reproductive system
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2018.
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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.
Alon Shrim, MD principal investigator
Hillel Yaffe Medical Center
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 Malignant Tumor of Women's Reproductive System, run by Hillel Yaffe 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 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: status not confirmed, as of the sponsor's last update on 26 Jul 2018. 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.
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 Genya Peisahov, BSc (972-54-8886349, genyap@hymc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early characterization of malignant tumors (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 26 Jul 2018.