Endometrial CancerSCREEN-CUPNCT07220239
Menstrual Cup for Early Endometrial Cancer Detection in Lynch Syndrome
A study testing Menstrual cup use in people with Endometrial Cancer and Lynch Syndrome, run by Jessica D. St. Laurent, MD at 1 site in United States.
Trial summary
Study Goal: This pilot study wants to find out if using a menstrual cup can be a good, non-invasive way to collect samples from the lining of the uterus (called the endometrium) to help screen for endometrial cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometrial Cancer, Lynch Syndrome, Screening
- What is being tested?
- Menstrual cup use
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2025to Mar 2027
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals over the age of 18
- Menstruating
Who cannot join
- Levonorgestrel intrauterine device (IUD) in situ or removed within the last 30 days prior to sample collection
- Patients with prior endometrial ablation
- Prior history of endometrial cancer or endometrial intraepithelial neoplasia
- History of germline pathologic germline variant in MLH1, MSH2, MSH6, PMS2, or EPCAM
- Known allergy against menstrual cup material (silicone)
- Main Study Inclusion criteria
Show all 16Show fewer
- LS carrier with a pathogenic or likely pathogenic germline variant in MLH1, MSH2, MSH6, PMS2, or EPCAM
- Individuals over the age of 18
- Planned screening EMB
- Menstruating
- Ability to give consent
- Current pregnancy
- Levonorgestrel IUD in situ or removed within the last 30 days prior to sample collection
- Patients with prior endometrial ablation
- Prior history of endometrial cancer
- Known allergy against menstrual cup material (silicone)
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
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Jessica D St. Laurent, MD, 4135635543, jdstlaurent@bwh.harvard.edu
Laura Wollborn, MD, 617 ext. 5823347, lwollborn@bwh.harvard.edu
About this study
Official title: Menstrual Cup-based Endometrial Collection as an Alternative to Endometrial Biopsy in Lynch Syndrome Patients
Study Goal:
This pilot study wants to find out if using a menstrual cup can be a good, non-invasive way to collect samples from the lining of the uterus (called the endometrium) to help screen for endometrial cancer. This is especially important for women who have a higher chance of getting this cancer, such as those with a genetic condition called Lynch syndrome.
Read more
Main Questions the Study Will Answer:
- Can a menstrual cup collect enough uterine lining (endometrial tissue) for doctors to examine under a microscope?
- Are the samples from the menstrual cup as useful for diagnosis as samples taken using the usual method (called an endometrial biopsy or EMB)?
- Is using a menstrual cup at home easy, effective, and comfortable for participants?
- Can scientists grow small lab models of the uterus (called organoids) from the menstrual cup samples and from biopsy samples?
What Will Happen in the Study:
- Participants will use a menstrual cup at home to collect menstrual blood.
- They will also have a standard endometrial biopsy done by a healthcare provider.
- After both collections, participants will fill out a short survey about how comfortable and easy it was to use the menstrual cup.
What the Study Will Measure:
- Feasibility: How well participants are able to use the menstrual cup and send in the sample.
- Sample Quality: Whether the menstrual cup collects enough good-quality tissue for testing, and how it compares to biopsy samples.
- Participant Experience: How women feel about using the menstrual cup, based on the survey.
- Lab Testing: Whether researchers can successfully grow endometrial organoids from both types of samples.
Why This Study Matters: If this method works, it could offer a gentler, more convenient way for women to get checked for endometrial cancer-especially those who need regular screening. It could also make it easier to collect samples for research and improve early detection of cancer.
Read the detailed description
Menstrual Cup for Early Endometrial Cancer Detection in Lynch Syndrome (SCREEN-CUP) The study entails two parts that will be conducted one after each other.
- Pre-pilot study Pre-pilot study including 5 menstruating females who will provide a one-time menstrual cup-based endometrial collection for the generation of organoids and for a pathological evaluation of endometrial specimen from menstrual fluid. After optimizing the study protocol in the pre-pilot study period, the main study will be conducted.
- Main pilot study Prospective feasibility study including 20 female Lynch syndrome (LS) carriers undergoing annual endometrial biopsy for endometrial cancer surveillance or suspected endometrial pathology will provide a one-time menstrual cup-based endometrial collection and endometrial biopsy specimen. One study aim is to evaluate the comparability and quality of the menstrual cup-based endometrial collection with the EMB sample from the same patient. For the second study aim, endometrial sample collected with the menstrual cup and EMB will be used and compared for organoid generation. Patient satisfaction and feasibility will be monitored through patient and provider questionnaires.
- Being tested
- Menstrual cup use
- Keywords
- Endometrial Cancer, Lynch Syndrome, Screening, Early detection, Organoids
- Medical subject headings
- Endometrial Neoplasms, Colorectal Neoplasms, Hereditary Nonpolyposis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Menstrual cup useDevice
Menstrual cup use in menstruating women to collect menstrual fluid with the aim to 1) compare the histology to endometrial biopsy samples from the same patient, to 2) investigate the feasibility and clinical utility of a menstrual cup use as a screening method for endometrial cancer and to 3) generate organoids from the menstrual cup samples
| Study group | Role | What they receive |
|---|---|---|
| Pilot study arm | Other | Single arm study: Intervention includes use of a mentrual cup to collect menstrual fluid Receives: Device: Menstrual cup use |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of samples considered adequate for pathologic evaluation
A pathologist will evaluate the menstrual cup-based sample and record its adequacy for pathological evaluation using a questionnaire with binary responses.
Measured: Postprocedural (7-14 days after study visit #2)
Secondary outcomes (4)
Overall participant satisfaction with menstrual cup collection for endometrial screening.
Participants self-report to questions on overall participant satisfaction with menstrual cup collection for endometrial screening with 5 answer possibilities ranging from "very satisfied" to "very dissatisfied".
Measured: Periprocedural (on day of study visit #2)
Successful endometrial organoid generation from menstrual cup sample
Successful organoid generation from menstrual cup samples will be assessed by viability assays after 5 days of culture and immunofluorescence imaging to compare cell composition.
Measured: Postprocedural (5-7 days after study visit #2)
Successful endometrial organoid generation from endometrial biopsy sample (EMB).
Successful organoid generation from EMB samples will be assessed by viability assays after 5 days of culture and immunofluorescence imaging to compare cell composition.
Measured: Postprocedural (5-7 days after study visit #2)
Provider satisfaction of menstrual cup collection for endometrial cancer screening within this study setting
Provider self-report on question regarding satisfaction of menstrual cup collection for endometrial cancer screening within this study setting with 5 answer possiblities ranging from "very satisfied" to "very dissatisfied".
Measured: Through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2025
- Study start20 Nov 2025
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pre-Pilot study: one study arm with healthy women Main Pilot study: one study arm with Lynch syndrome carriers
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jessica D. St. Laurent, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Dana-Farber Cancer Institute
- Responsible party
- Sponsor-investigator, Jessica D. St. Laurent, MD, Brigham and Women's Hospital
- Investigators
- Jessica D St. Laurent, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07220239
- Sponsor's protocol ID
- 25-416
- Acronym
- SCREEN-CUP
- Status last verified
- Jun 2026
- First submitted
- 11 Aug 2025
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a data use agreement. The protocol and statistical analysis plan will be made available to on clinicaltrials.gov only as required by federal regulations or as a condition of awards and agreements supporting research.
Publications
Cindrova-Davies T, Zhao X, Elder K, Jones CJP, Moffett A, Burton GJ, Turco MY. Menstrual flow as a non-invasive source of endometrial organoids. Commun Biol. 2021 Jun 17;4(1):651. doi: 10.1038/s42003-021-02194-y.
PubMed 34140633Jenkins RW, Aref AR, Lizotte PH, Ivanova E, Stinson S, Zhou CW, Bowden M, Deng J, Liu H, Miao D, He MX, Walker W, Zhang G, Tian T, Cheng C, Wei Z, Palakurthi S, Bittinger M, Vitzthum H, Kim JW, Merlino A, Quinn M, Venkataramani C, Kaplan JA, Portell A, Gokhale PC, Phillips B, Smart A, Rotem A, Jones RE, Keogh L, Anguiano M, Stapleton L, Jia Z, Barzily-Rokni M, Canadas I, Thai TC, Hammond MR, Vlahos R, Wang ES, Zhang H, Li S, Hanna GJ, Huang W, Hoang MP, Piris A, Eliane JP, Stemmer-Rachamimov AO, Cameron L, Su MJ, Shah P, Izar B, Thakuria M, LeBoeuf NR, Rabinowits G, Gunda V, Parangi S, Cleary JM, Miller BC, Kitajima S, Thummalapalli R, Miao B, Barbie TU, Sivathanu V, Wong J, Richards WG, Bueno R, Yoon CH, Miret J, Herlyn M, Garraway LA, Van Allen EM, Freeman GJ, Kirschmeier PT, Lorch JH, Ott PA, Hodi FS, Flaherty KT, Kamm RD, Boland GM, Wong KK, Dornan D, Paweletz CP, Barbie DA. Ex Vivo Profiling of PD-1 Blockade Using Organotypic Tumor Spheroids. Cancer Discov. 2018 Feb;8(2):196-215. doi: 10.1158/2159-8290.CD-17-0833. Epub 2017 Nov 3.
PubMed 29101162Hewitt SC, Dickson MJ, Edwards N, Hampton K, Garantziotis S, DeMayo FJ. From cup to dish: how to make and use endometrial organoid and stromal cultures derived from menstrual fluid. Front Endocrinol (Lausanne). 2023 Sep 21;14:1220622. doi: 10.3389/fendo.2023.1220622. eCollection 2023.
PubMed 37810883
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Menstrual Cup-based Endometrial Collection as an Alternative to Endometrial Biopsy in Lynch Syndrome Patients
- ClinicalTrials.gov ID
- NCT07220239
- Acronym / sponsor ID
- SCREEN-CUP / 25-416
- Keywords
- Endometrial Cancer, Lynch Syndrome, Screening, Early detection, Organoids
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Jessica D. St. Laurent, MDUniversity, hospital or other
- Collaborators
- Dana-Farber Cancer Institute
- Study start
- 20 Nov 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 23 Oct 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.
Study Goal:
This pilot study wants to find out if using a menstrual cup can be a good, non-invasive way to collect samples from the lining of the uterus (called the endometrium) to help screen for endometrial cancer. This is especially important for women who have a higher chance of getting this cancer, such as those with a genetic condition called Lynch syndrome.
Main Questions the Study Will Answer:
- Can a menstrual cup collect enough uterine lining (endometrial tissue) for doctors to examine under a microscope?
- Are the samples from the menstrual cup as useful for diagnosis as samples taken using the usual method (called an endometrial biopsy or EMB)?
- Is using a menstrual cup at home easy, effective, and comfortable for participants?
- Can scientists grow small lab models of the uterus (called organoids) from the menstrual cup samples and from biopsy samples?
What Will Happen in the Study:
- Participants will use a menstrual cup at home to collect menstrual blood.
- They will also have a standard endometrial biopsy done by a healthcare provider.
- After both collections, participants will fill out a short survey about how comfortable and easy it was to use the menstrual cup.
What the Study Will Measure:
- Feasibility: How well participants are able to use the menstrual cup and send in the sample.
- Sample Quality: Whether the menstrual cup collects enough good-quality tissue for testing, and how it compares to biopsy samples.
- Participant Experience: How women feel about using the menstrual cup, based on the survey.
- Lab Testing: Whether researchers can successfully grow endometrial organoids from both types of samples.
Why This Study Matters: If this method works, it could offer a gentler, more convenient way for women to get checked for endometrial cancer-especially those who need regular screening. It could also make it easier to collect samples for research and improve early detection of cancer.
Detailed description
Menstrual Cup for Early Endometrial Cancer Detection in Lynch Syndrome (SCREEN-CUP) The study entails two parts that will be conducted one after each other.
- Pre-pilot study Pre-pilot study including 5 menstruating females who will provide a one-time menstrual cup-based endometrial collection for the generation of organoids and for a pathological evaluation of endometrial specimen from menstrual fluid. After optimizing the study protocol in the pre-pilot study period, the main study will be conducted.
- Main pilot study Prospective feasibility study including 20 female Lynch syndrome (LS) carriers undergoing annual endometrial biopsy for endometrial cancer surveillance or suspected endometrial pathology will provide a one-time menstrual cup-based endometrial collection and endometrial biopsy specimen. One study aim is to evaluate the comparability and quality of the menstrual cup-based endometrial collection with the EMB sample from the same patient. For the second study aim, endometrial sample collected with the menstrual cup and EMB will be used and compared for organoid generation. Patient satisfaction and feasibility will be monitored through patient and provider questionnaires.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pre-Pilot study: one study arm with healthy women Main Pilot study: one study arm with Lynch syndrome carriers
| Arm | Type | Receives |
|---|---|---|
| Pilot study arm | Other | Device: Menstrual cup useSingle arm study: Intervention includes use of a mentrual cup to collect menstrual fluid |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Individuals over the age of 18
- Menstruating
Key exclusion criteria (16 listed)
- Levonorgestrel intrauterine device (IUD) in situ or removed within the last 30 days prior to sample collection
- Patients with prior endometrial ablation
- Prior history of endometrial cancer or endometrial intraepithelial neoplasia
- History of germline pathologic germline variant in MLH1, MSH2, MSH6, PMS2, or EPCAM
- Known allergy against menstrual cup material (silicone)
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 |
|---|---|---|
| Menstrual cup useMenstrual cup use in menstruating women to collect menstrual fluid with the aim to 1) compare the histology to endometrial biopsy samples from the same patient, to 2) investigate the feasibility and clinical utility of a menstrual cup use as a screening method for endometrial cancer and to 3) generate organoids from the menstrual cup samples | Device | Pilot study arm |
Primary outcome
Proportion of samples considered adequate for pathologic evaluation
Time frame: Postprocedural (7-14 days after study visit #2)
A pathologist will evaluate the menstrual cup-based sample and record its adequacy for pathological evaluation using a questionnaire with binary responses.
4 secondary outcomes
Overall participant satisfaction with menstrual cup collection for endometrial screening.
Time frame: Periprocedural (on day of study visit #2)
Successful endometrial organoid generation from menstrual cup sample
Time frame: Postprocedural (5-7 days after study visit #2)
Successful endometrial organoid generation from endometrial biopsy sample (EMB).
Time frame: Postprocedural (5-7 days after study visit #2)
Provider satisfaction of menstrual cup collection for endometrial cancer screening within this study setting
Time frame: Through study completion, an average of 1 year.
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 10 Jun 2026.
- Background: PubMed 34140633Cindrova-Davies T, Zhao X, Elder K, Jones CJP, Moffett A, Burton GJ, Turco MY. Menstrual flow as a non-invasive source of endometrial organoids. Commun Biol. 2021 Jun 17;4(1):651. doi: 10.1038/s42003-021-02194-y.
- Background: PubMed 29101162Jenkins RW, Aref AR, Lizotte PH, Ivanova E, Stinson S, Zhou CW, Bowden M, Deng J, Liu H, Miao D, He MX, Walker W, Zhang G, Tian T, Cheng C, Wei Z, Palakurthi S, Bittinger M, Vitzthum H, Kim JW, Merlino A, Quinn M, Venkataramani C, Kaplan JA, Portell A, Gokhale PC, Phillips B, Smart A, Rotem A, Jones RE, Keogh L, Anguiano M, Stapleton L, Jia Z, Barzily-Rokni M, Canadas I, Thai TC, Hammond MR, Vlahos R, Wang ES, Zhang H, Li S, Hanna GJ, Huang W, Hoang MP, Piris A, Eliane JP, Stemmer-Rachamimov AO, Cameron L, Su MJ, Shah P, Izar B, Thakuria M, LeBoeuf NR, Rabinowits G, Gunda V, Parangi S, Cleary JM, Miller BC, Kitajima S, Thummalapalli R, Miao B, Barbie TU, Sivathanu V, Wong J, Richards WG, Bueno R, Yoon CH, Miret J, Herlyn M, Garraway LA, Van Allen EM, Freeman GJ, Kirschmeier PT, Lorch JH, Ott PA, Hodi FS, Flaherty KT, Kamm RD, Boland GM, Wong KK, Dornan D, Paweletz CP, Barbie DA. Ex Vivo Profiling of PD-1 Blockade Using Organotypic Tumor Spheroids. Cancer Discov. 2018 Feb;8(2):196-215. doi: 10.1158/2159-8290.CD-17-0833. Epub 2017 Nov 3.
- Background: PubMed 37810883Hewitt SC, Dickson MJ, Edwards N, Hampton K, Garantziotis S, DeMayo FJ. From cup to dish: how to make and use endometrial organoid and stromal cultures derived from menstrual fluid. Front Endocrinol (Lausanne). 2023 Sep 21;14:1220622. doi: 10.3389/fendo.2023.1220622. eCollection 2023.
- Individual participant dataSharing planned: Yes. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a data use agreement. The protocol and statistical analysis plan will be made available to on clinicaltrials.gov only as required by federal regulations or as a condition of awards and agreements supporting research.
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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.
Jessica D St. Laurent, MD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Menstrual cup use in people with Endometrial Cancer and Lynch Syndrome, run by Jessica D. St. Laurent, MD 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 2 inclusion and 16 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 10 Jun 2026. 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 Jessica D St. Laurent, MD (857-215-1892, jdstlaurent@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of samples considered adequate for pathologic evaluation (time frame: Postprocedural (7-14 days after study visit #2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07220239, which also lists 3 linked publications.
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 10 Jun 2026.