Menstrual Cup for Early Endometrial Cancer Detection in Lynch Syndrome

NCT ID: NCT07220239

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-20
• Study Completion Date: 2026-09-30

Brief 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. 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.

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 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.

Conditions

Endometrial Cancer; Lynch Syndrome; Screening; Early Detection of Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Pilot study arm

Single arm study: Intervention includes use of a mentrual cup to collect menstrual fluid

Group Type: OTHER

Menstrual cup use

Intervention Type: DEVICE

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 utiliy of a menstrual cup use as a screening method for endometrial cancer and to 3) generate organoids from the menstrual cup samples

Interventions

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 utiliy of a menstrual cup use as a screening method for endometrial cancer and to 3) generate organoids from the menstrual cup samples

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Individuals over the age of 18
• Menstruating

• 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

• 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 or endometrial intraepithelial neoplasia
• History of germline pathologic germline variant in MLH1, MSH2, MSH6, PMS2, or EPCAM
• Known allergy against menstrual cup material (silicone)

• 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Dana-Farber Cancer Institute

OTHER

Sponsor Role: collaborator

Jessica D. St. Laurent, MD

OTHER

Sponsor Role: lead

Responsible Party

Jessica D. St. Laurent, MD

Director, Gynecologic Oncology Laboratory

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jessica D St. Laurent, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jessica D St. Laurent, MD

Role: CONTACT

jdstlaurent@bwh.harvard.edu

4135635543

Facility Contacts

Jessica D St. Laurent, MD

Role: primary

jdstlaurent@bwh.harvard.edu

4135635543

Laura Wollborn, MD

Role: backup

lwollborn@bwh.harvard.edu

617 ext. 5823347

References

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.

Reference Type: BACKGROUND

PMID: 34140633 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29101162 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 37810883 (View on PubMed)

Other Identifiers

25-416

Identifier Type: -

Identifier Source: org_study_id