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NCT Number: NCT07220239

Menstrual Cup for Early Endometrial Cancer Detection in Lynch Syndrome

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.

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Key information

Conditions

Endometrial Cancer Colonic Diseases Colorectal Neoplasms Colorectal Neoplasms, Hereditary Nonpolyposis Congenital, Hereditary, and Neonatal Diseases and Abnormalities DNA Repair-Deficiency Disorders Digestive System Diseases Digestive System Neoplasms Early Detection of Cancer Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genetic Diseases, Inborn Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Intestinal Diseases Intestinal Neoplasms Lynch Syndrome Metabolic Diseases Neoplasms Neoplasms by Site Neoplastic Syndromes, Hereditary Nutritional and Metabolic Diseases Screening Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location status: Recruiting

Location contact

Jessica D St. Laurent, MD

CONTACT

[email protected]

4135635543

Jessica D St. Laurent, MD

PRINCIPAL_INVESTIGATOR

Laura Wollborn, MD

CONTACT

[email protected]

617 ext. 5823347

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Primary outcomes

  1. 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.

Secondary outcomes

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

    Time frame: Periprocedural (on day of study visit #2)

    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".

  2. Successful endometrial organoid generation from menstrual cup sample

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

    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.

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

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

    Successful organoid generation from EMB samples will be assessed by viability assays after 5 days of culture and immunofluorescence imaging to compare cell composition.

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

    Time frame: Through study completion, an average of 1 year.

    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".

Study contacts

Contact information is provided by the study sponsor or research team.

Jessica D St. Laurent, MD

CONTACT

[email protected]

857-215-1892

Sponsors and collaborators

Lead sponsor

Jessica D. St. Laurent, MD

Other

Collaborators

  • Dana-Farber Cancer Institute

Registry information

Official study title

Menstrual Cup-based Endometrial Collection as an Alternative to Endometrial Biopsy in Lynch Syndrome Patients

Acronym: SCREEN-CUP

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Oct 23, 2025
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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