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Study of Ovarian Failure Needs Newly Diagnosed Young Women

POISE trial to look at pre-chemotherapy biological markers

Trial Starts: September 2008; Trial Ends: August 2015

Written By Robin Warshaw
Reviewed By Kutluk Oktay, MD

Researchers seek premenopausal women newly diagnosed with breast cancer for the POISE (Predictors of Ovarian Insufficiency in Young Breast Cancer Patients) study, which seeks to identify biological markers that predict the risk for ovarian failure after chemotherapy.

About the Study

Chemotherapy can affect the ovaries, resulting in ovarian insufficiency or failure. That may affect what type of additional therapy may be given, fertility and reproduction, early onset of menopause and outcome.

Testing participants’ biological factors, this study will look at hormone levels that reflect ovarian function, gene mutations that influence the way chemotherapy metabolizes, size of the ovaries and egg count. The researchers believe these factors may relate to the risk of ovarian insufficiency.

The study will follow participants from breast cancer diagnosis to five years after chemotherapy, to determine if and when either the ovaries stop working (measured as no menstruation for 12 months) or menstruation returns after 12 months.

The researchers plan to use the information gathered in the study to develop a tool that can predict the risk of ovarian failure. In the future, this tool could help young women diagnosed with breast cancer and their doctors decide on the best treatment to benefit future fertility as well as survival.

Who Is Eligible to Participate?

You may be able to take part in this study if you:

  • are a premenopausal woman (at least one menstrual period in the past year);
  • are age 18 to 45;
  • have a new diagnosis of stage 0 to III breast cancer;
  • have not had chemotherapy at any time.

Participants may be included whether they will undergo chemotherapy or not.

Study Locations and Activities

The POISE study is being carried out at three locations:

  • University of California, San Diego
  • University of Southern California (Los Angeles)
  • University of Pennsylvania (Philadelphia)

Full participants will go to the location near them regularly for blood draws, other testing and to answer questionnaires. They will also keep track of menstrual cycles. Study visits will occur at joining, three months later and six months after joining. Visits will then continue every six months for five years.

If you do not live in these areas, you may participate at a different level by giving permission for the researchers to access your medical records and by tracking menstrual cycles.

Contact Information

For more details or to find out about becoming a participant in the POISE study, contact Leslie Barbier at poisestudyucsd@gmail.com or (858) 822-6790.

For more information, visit clinicaltrials.gov.

This article was supported by Cooperative Agreement Number DP11-1111 from The Centers for Disease Control and Prevention. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the Centers for Disease Control and Prevention.

Denver, CO  ·  September 13, 2014

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