NCT02477202

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

June 15, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 22, 2015

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 29, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 29, 2022

Completed
10 months until next milestone

Results Posted

Study results publicly available

October 16, 2023

Completed
Last Updated

October 16, 2023

Status Verified

January 1, 2023

Enrollment Period

7.6 years

First QC Date

June 15, 2015

Results QC Date

September 19, 2023

Last Update Submit

September 19, 2023

Conditions

Epithelial Ovarian Cancer

Keywords

Mirena® IUD'sWomenrisk-reducing salpingo-oophorectomyrisk-reducing salpingectomy

Outcome Measures

Primary Outcomes (1)

  • Cell Proliferation in the Fallopian Tube Fimbriae as Measured by Ki-67%+

    Women will be deemed evaluable for this primary outcome if they successfully underwent placement of the Mirena® IUD, received a RRSO or RRS as planned, and had a P4 value ≤1 ng/ml.

    1 year

Study Arms (1)

Mirena® IUD

EXPERIMENTAL

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.

Device: Mirena® intra-uterine device (IUD)

Interventions

Mirena® intra-uterine device (IUD)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).

Mirena® IUD

Eligibility Criteria

Age35 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, 07920, United States

Location

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Commack

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Rockville Centre

Rockville Centre, New York, United States

Location

Related Links

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsOvarian NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Results Point of Contact

Title
Dr. Dennis Chi, MD
Organization
Memorial Sloan Kettering Cancer Center
chid@MSKCC.ORG
212-639-5016

Study Officials

  • Dennis Chi, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2015

First Posted

June 22, 2015

Study Start

June 1, 2015

Primary Completion

December 29, 2022

Study Completion

December 29, 2022

Last Updated

October 16, 2023

Results First Posted

October 16, 2023

Record last verified: 2023-01

Locations

US(6)