Menstrual Cup for Early Endometrial Cancer Detection in Lynch Syndrome

NCT07220239 | Recruiting

• 1 other identifier: 25-416
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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:

• 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.

Conditions

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

Keywords

Endometrial Cancer; Lynch Syndrome; Screening; Early detection; Organoids

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Overall participant satisfaction with menstrual cup collection for endometrial screening.

  Periprocedural (on day of study visit #2)

• Successful endometrial organoid generation from menstrual cup sample

  Postprocedural (5-7 days after study visit #2)

• Successful endometrial organoid generation from endometrial biopsy sample (EMB).

  Postprocedural (5-7 days after study visit #2)

• Provider satisfaction of menstrual cup collection for endometrial cancer screening within this study setting

  Through study completion, an average of 1 year.

Study Arms (1)

Pilot study arm

OTHER

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

Device: Menstrual cup use

Interventions

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

Pilot study arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals over the age of 18
• Menstruating

You may not qualify if:

• 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)
• 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)

Sponsors & Collaborators

• Jessica D. St. Laurent, MD: lead
• Dana-Farber Cancer Institute: collaborator

Study Sites (1)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

Related Publications (3)

• 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.

  PMID: 34140633 BACKGROUND

• 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.

  PMID: 29101162 BACKGROUND

• 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.

  PMID: 37810883 BACKGROUND

MeSH Terms

Conditions

Endometrial Neoplasms; Colorectal Neoplasms, Hereditary Nonpolyposis

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplastic Syndromes, Hereditary; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; DNA Repair-Deficiency Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Jessica D St. Laurent, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica D St. Laurent, MD

CONTACT

857-215-1892; jdstlaurent@bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Only one part of the outcome assessor will be masked: the pathologist evaluating the EMB specimen and menstrual cup-collected specimen.
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Gynecologic Oncology Laboratory

Model Details: Pre-Pilot study: one study arm with healthy women Main Pilot study: one study arm with Lynch syndrome carriers

Study Record Dates

• First Submitted: August 11, 2025
• First Posted: October 23, 2025
• Study Start: November 20, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 12 months after publication of the primary results, for a period of up to 3 years.
• 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.

Locations

US (1)