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Search / Trial NCT05651282

Risk Evaluation and Screening to Tailor Prevention and Reduce the Incidence of Endometrial Cancer

Launched by UNIVERSITY OF BRITISH COLUMBIA · Dec 12, 2022

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Trial Information

Current as of January 22, 2025

Recruiting

Keywords

Screening Prevention Progesterone Challenge Test Women's Health Reproductive Health Menopause

ClinConnect Summary

This clinical trial is looking into ways to better identify and reduce the risk of endometrial cancer, which affects the lining of the uterus. The study will first assess participants' risk levels using a special model that predicts how likely they are to develop this cancer in the next ten years. If a participant has a risk of 2% or higher, or a Body Mass Index (BMI) over 34.9, they will undergo a follow-up screening called the Progesterone Challenge Test (PCT). This involves taking a medication daily for ten days, and if they experience withdrawal bleeding afterward, it suggests that further investigation is needed. Those who test positive will receive standard care, which may include a biopsy to check for cancer cells and hormone therapy.

To be eligible for the trial, participants must be postmenopausal (at least three years since their last menstrual period) and have an intact uterus (not had a hysterectomy). Participants should not be on certain hormone therapies or have experienced abnormal bleeding. Throughout the study, participants will also learn about making lifestyle changes through a program called "Small Steps for Big Changes." This trial aims to find safer, less invasive ways to screen for endometrial cancer and improve health outcomes for women at risk.

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • • Individuals are postmenopausal (must be three (3) years past last menstrual period)
  • • Individuals have an intact uterus (have not had a hysterectomy)
  • Exclusion Criteria:
  • • Individuals taking hormone therapy for menopause (including vaginal estrogen)
  • • Individuals taking male hormones,
  • • Individuals on anti-endocrine therapy (such as tamoxifen)
  • • Individuals on aromatase inhibitor therapy
  • • Individuals who have experienced abnormal uterine bleeding
  • • Individuals who have an Intrauterine Device (IUD)

Trial Officials

Aline Talhouk, PhD

Principal Investigator

University of British Columbia, Department of Obstetrics and Gynecology

Jessica McAlpine, MD

Principal Investigator

University of British Columbia, Department of Obstetrics and Gynecology

About University Of British Columbia

The University of British Columbia (UBC) is a leading research institution located in Vancouver, Canada, renowned for its commitment to advancing health sciences through innovative research and education. As a prominent clinical trial sponsor, UBC leverages its interdisciplinary expertise and state-of-the-art facilities to conduct rigorous clinical studies aimed at improving patient outcomes across various medical fields. The university fosters collaborations with healthcare professionals, industry partners, and community stakeholders to translate research findings into practical applications, thereby contributing to the global advancement of medicine and public health.

Locations

Vancouver, British Columbia, Canada

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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