Menstrual Cup for Early Endometrial Cancer Detection in Lynch Syndrome

Official title

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

Overview

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 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.

Interventions

• 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

Primary outcome measures

• Proportion of samples considered adequate for pathologic evaluation [Time frame: Postprocedural (7-14 days after study visit #2)]

Secondary outcome measures (4)

• 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.]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Screening

Study locations

United States · 1 center

• Dana-Farber Cancer Institute — Boston

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. PMID 34140633
• 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, Vlaho PMID 29101162
• 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

Identifiers

NCT: NCT07220239 · 25-416

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗