Menstrual Cup for Early Endometrial Cancer Detection in Lynch Syndrome (SCREEN-CUP)

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.

Main Questions the Study Will Answer:

1. Can a menstrual cup collect enough uterine lining (endometrial tissue) for doctors to examine under a microscope?
2. Are the samples from the menstrual cup as useful for diagnosis as samples taken using the usual method (called an endometrial biopsy or EMB)?
3. Is using a menstrual cup at home easy, effective, and comfortable for participants?
4. 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.

Study Overview

• Status: Recruiting
• Conditions: Lynch Syndrome; Endometrial Cancer; Early Detection of Cancer; Screening
• Intervention / Treatment: Device: Menstrual cup use

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.

1. 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.

2. 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 Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jessica D St. Laurent, MD; Phone Number: 857-215-1892; Email: jdstlaurent@bwh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Dana-Farber Cancer Institute
      • Contact: Jessica D St. Laurent, MD; Phone Number: 4135635543; Email: jdstlaurent@bwh.harvard.edu
      • Contact: Laura Wollborn, MD; Phone Number: 5823347 617; Email: lwollborn@bwh.harvard.edu
      • Principal Investigator: Jessica D St. Laurent, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Pre-pilot study

Inclusion criteria:

• Individuals over the age of 18
• Menstruating

Exclusion criteria:

• 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

• 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

Exclusion criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Pilot study arm; Single arm study: Intervention includes use of a mentrual cup to collect menstrual fluid	Device: Menstrual cup use; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Postprocedural (7-14 days after study visit #2)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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".	Through study completion, an average of 1 year.
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".	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.	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.	Postprocedural (5-7 days after study visit #2)

Collaborators and Investigators

• Sponsor: Jessica D. St. Laurent, MD
• Collaborators: Dana-Farber Cancer Institute
• Investigators: Principal Investigator: Jessica D St. Laurent, MD, Brigham and Women's Hospital

Publications and helpful links

General 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.
• Jenkins 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.
• Hewitt 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: August 11, 2025
• First Submitted That Met QC Criteria: October 21, 2025
• First Posted (Actual): October 23, 2025

Study Record Updates

• Last Update Posted (Actual): June 10, 2026
• Last Update Submitted That Met QC Criteria: June 9, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Screening; Endometrial Cancer; Early detection; Lynch Syndrome; Organoids
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genetic Diseases, Inborn; Metabolic Diseases; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Uterine Diseases; Genital Diseases, Female; Colonic Diseases; Genital Neoplasms, Female; Uterine Neoplasms; Neoplastic Syndromes, Hereditary; DNA Repair-Deficiency Disorders; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Nutritional and Metabolic Diseases; Endometrial Neoplasms; Colorectal Neoplasms, Hereditary Nonpolyposis
• Other Study ID Numbers: 25-416

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Beginning 12 months after publication of the primary results, for a period of up to 3 years.
• IPD Sharing Access Criteria: Researchers must submit a methodologically sound proposal and demonstrate an IRB-approved protocol. Requests maybe directed to the sponsor investigator or designee. A formal data use agreement will be required prior to access.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes