Gynecologic CancerNCT07044505
Molecular and Cellular Profiling of Uterine Lavage Collected During Gynecologic Surgery
A study testing Uterine Lavage in people with Gynecologic Cancer and Gynecologic Disease, run by Stanford University at 1 site in United States.
Trial summary
This study is a designed as a to test the clinical and technical feasibility of using this novel uterine lavage collection catheter to collected UL samples from up to 50 individuals undergoing gynecologic surgery and to describe the cellular composition of these samples. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gynecologic Cancer, Gynecologic Disease, Gynecological Surgery
- What is being tested?
- Uterine Lavage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Sep 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing gynecologic surgery with Stanford Healthcare
- Intact uterus and cervix
- At least one intact fallopian tube and ovary (on the same side)
- Aged 18 years or older
- Ability to understand and the willingness to provide written informed consent.
Who cannot join
- Known endometrial or cervical cancer or endometrial or cervical intraepithelial neoplasia
- Status post bilateral salpingectomy or tubal ligation
- Lack of consenting capacity
- Positive preoperative pregnancy test
- Active uterine bleeding (i.e. menses, etc.)
- Intrauterine device in place
- Non-English speaking (requires interpretor)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Stanford University
Palo Alto, California, 94304
Rozelle Laquindanum, 650-724-9948, rlaquind@stanford.edu
James Ford, MD
About this study
Official title: Exploring the Molecular and Cellular Composition of Uterine Lavage Specimens Collected at the Time of Gynecologic Surgery.
This study is a designed as a to test the clinical and technical feasibility of using this novel uterine lavage collection catheter to collected UL samples from up to 50 individuals undergoing gynecologic surgery and to describe the cellular composition of these samples. In order to do this, it is a prospective consecutively-enrolled cohort of 50 participants, all of who will receive the intervention of uterine lavage collection.
- Being tested
- Uterine Lavage
- Medical subject headings
- Genital Diseases, Female, Uterine Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Uterine LavageProcedure or surgery
Saline is introduced into the uterine cavity and retrieved during surgery to collect cells and fluid for downstream molecular and cellular analyses.
| Study group | Role | What they receive |
|---|---|---|
| Single Group | Experimental | Participants undergoing gynecologic surgery who agree to uterine lavage collection intraoperatively for molecular and cellular analysis. Receives: Procedure: Uterine Lavage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterization of cellular composition in uterine lavage fluid
Quantification and classification of cell types obtained from uterine lavage specimens using cytology and/or flow cytometry.
Measured: At time of gynecologic surgery
Secondary outcomes (2)
Molecular profiling of uterine lavage specimens
Analysis of RNA, DNA, or protein expression profiles in collected lavage fluid.
Measured: At time of surgery
Detection of inflammatory biomarkers in uterine lavage
Measurement of cytokines or other markers associated with uterine immune status or pathology.
Measured: At time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start19 Sep 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic CancerStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James Ford, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07044505
- Sponsor's protocol ID
- IRB-77882
- Status last verified
- Nov 2025
- First submitted
- 23 Jun 2025
- Last updated
- 5 Nov 2025
- 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 5 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Molecular and Cellular Composition of Uterine Lavage Specimens Collected at the Time of Gynecologic Surgery.
- ClinicalTrials.gov ID
- NCT07044505
- Acronym / sponsor ID
- IRB-77882
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 19 Sep 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 1 Jul 2025 (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.
This study is a designed as a to test the clinical and technical feasibility of using this novel uterine lavage collection catheter to collected UL samples from up to 50 individuals undergoing gynecologic surgery and to describe the cellular composition of these samples. In order to do this, it is a prospective consecutively-enrolled cohort of 50 participants, all of who will receive the intervention of uterine lavage collection.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Group | Experimental | Procedure: Uterine LavageParticipants undergoing gynecologic surgery who agree to uterine lavage collection intraoperatively for molecular and cellular analysis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Undergoing gynecologic surgery with Stanford Healthcare
- Intact uterus and cervix
- At least one intact fallopian tube and ovary (on the same side)
- Aged 18 years or older
- Ability to understand and the willingness to provide written informed consent.
Key exclusion criteria (7 listed)
- Known endometrial or cervical cancer or endometrial or cervical intraepithelial neoplasia
- Status post bilateral salpingectomy or tubal ligation
- Lack of consenting capacity
- Positive preoperative pregnancy test
- Active uterine bleeding (i.e. menses, etc.)
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 |
|---|---|---|
| Uterine LavageSaline is introduced into the uterine cavity and retrieved during surgery to collect cells and fluid for downstream molecular and cellular analyses. | Procedure or surgery | Single Group |
Primary outcome
Characterization of cellular composition in uterine lavage fluid
Time frame: At time of gynecologic surgery
Quantification and classification of cell types obtained from uterine lavage specimens using cytology and/or flow cytometry.
2 secondary outcomes
Molecular profiling of uterine lavage specimens
Time frame: At time of surgery
Detection of inflammatory biomarkers in uterine lavage
Time frame: At time of surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2025.
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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.
James Ford, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Uterine Lavage in people with Gynecologic Cancer and Gynecologic Disease, run by Stanford University at 1 site in United States.
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 5 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 5 Nov 2025. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rozelle Laquindanum ((650) 724-9948, rlaquind@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterization of cellular composition in uterine lavage fluid (time frame: At time of gynecologic surgery). 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 5 Nov 2025.