Mirena® IUD's Effect on Fallopian Tube Fimbriae and Ovarian Cortical Inclusion Cyst Cell Proliferation

NCT ID: NCT02477202

Last Updated: 2023-10-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2022-12-29

Brief Summary

Combination-type oral contraceptives (COCs) have been shown to significantly reduce the risk of invasive epithelial ovarian cancer (IEOC); this protective effect may be achieved to a large extent through COCs ability to reduce cell proliferation in the fallopian tube fimbriae (FTF). The progestin-releasing Mirena® intra-uterine device (IUD) is an increasingly popular method of contraception, but it is not known if its use will reduce a woman's risk of IEOC. Mirena® use does not block ovulation in most women but it may release sufficient progestin to also reduce cell proliferation in the FTF. This study aims to evaluate the effects of the Mirena® IUD on cell proliferation in the FTF as a possible biomarker of protection against IEOC.

Conditions

Epithelial Ovarian Cancer

Study Design

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

Study Groups

Mirena® IUD

This is a non-randomized study of the effect of Mirena® IUD use of at least 10 days before an RRSO or RRS on cell proliferation within the FTF and when available within ovarian CICs in women aged 35 through 50. The study will compare the results from 14 women using Mirena® with the results from 28 normally cycling women identified under MSK IRB Protocol #14-165 described above; all patients will be aged 35-50 years, and will have undergone the RRSO at MSK. To date we have identified approximately 100 suitable controls and are continuing to identify further suitable controls among women who have recently undergone RRSOs at MSK. The balancing/matching factors will be BRCA status (BRCA1/BRCA2/BRCA-ve), age (35-39/40-44/45-50), parity (nulliparous/parous), and BMI (\<30/30+ kg/m\^2). As each Mirena® patient completes the study and is deemed evaluable, she will be matched on each of these factors with 2 controls.

Group Type: EXPERIMENTAL

Mirena® intra-uterine device (IUD)

Intervention Type: DEVICE

In this study, a Mirena® IUD will be inserted into volunteers scheduled for a risk-reducing salpingo-oophorectomy (RRSO) or risk-reducing salpingectomy (RRS) at Memorial Sloan Kettering Cancer Center (MSK). Alternatively, women with a Mirena® IUD already in place and who will be scheduled for an RRSO or RRS at MSK can also participate. We are seeking 14 evaluable participants. FTF tissue (and ovarian inclusion cyst tissue, when available) collected at the time of risk-reducing salpingectomy (RRS) will be tested by immunochemistry staining for Ki67 (a protein that is significantly increased when cells are preparing for division).

Interventions

Mirena® intra-uterine device (IUD)

In this study, a Mirena® IUD will be inserted into volunteers scheduled for a risk-reducing salpingo-oophorectomy (RRSO) or risk-reducing salpingectomy (RRS) at Memorial Sloan Kettering Cancer Center (MSK). Alternatively, women with a Mirena® IUD already in place and who will be scheduled for an RRSO or RRS at MSK can also participate. We are seeking 14 evaluable participants. FTF tissue (and ovarian inclusion cyst tissue, when available) collected at the time of risk-reducing salpingectomy (RRS) will be tested by immunochemistry staining for Ki67 (a protein that is significantly increased when cells are preparing for division).

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Women between 35 and 50 years of age (inclusive)
• Women who will be scheduled to undergo an RRSO or RRs
• Women who will have at least one fallopian tube removed for risk-reducing reasons (with or without removal of ovar(ies))
• Women who are willing to have a Mirena® IUD inserted at least prior to risk-reducing surgery or who already have the Mirena® in place
• Women using non-hormonal forms of contraception (Note: If a copper IUD is being used, the IUD must be removed prior to or at time of Mirena insertion.)

Exclusion Criteria

• Any medical contraindication to use of a Mirena® IUD, including:

• Pregnancy (a pregnancy test is required prior to study entry)
• Known uterine anomaly that distorts the shape of the uterine cavity
• Acute pelvic inflammatory disease
• Postpartum endometritis or endometrial infection
• Known or suspected uterine or cervical neoplasia
• Known history or suspected breast cancer or other progestin-sensitive cancer
• Uterine bleeding of unknown etiology.
• Untreated acute cervicitis, vaginitis, or other lower genital tract infections
• Acute liver disease or liver tumor (benign or malignant)
• Use of tamoxifen, raloxifene, or chemotherapy within the previous 6 months
• Positive pregnancy test
• Breastfeeding
• Use of a copper IUD if the patient is not willing to have it removed prior to surgery and replaced with a Mirena® IUD

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dennis Chi, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, United States

Memorial Sloan Kettering Commack

Commack, New York, United States

Memorial Sloan Kettering Westchester

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Memorial Sloan Kettering Rockville Centre

Rockville Centre, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

https://www.mskcc.org/

Memorial Sloan Kettering Cancer Center

Other Identifiers

15-105

Identifier Type: -

Identifier Source: org_study_id