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Assessing Reproductive Outcomes in Young Female Cancer Survivors Through a National Fertility Preservation Registry

This study is currently recruiting participants.
Verified May 2016 by Hui-Chun Irene Su, University of California, San Diego
Sponsor:
ClinicalTrials.gov Identifier:
NCT01843140
First Posted: April 30, 2013
Last Update Posted: May 16, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Hui-Chun Irene Su, University of California, San Diego
  Purpose
The FIRST project is a national fertility preservation registry for young women facing cancer treatments. The investigators will examine how different cancers and treatments affect the reproductive health of young survivors. This prospective cohort study seeks to recruit young women close to time of cancer diagnosis and treatment. Participants will answer a yearly questionnaire on their current health. A subset of participants will provide dried blood spots to measure reproductive hormones. The primary goal of the study is to determine the risk of infertility and time to pregnancy in young female cancer survivors.

Condition
Cancer Infertilty

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Fertility Information Research Study

Further study details as provided by Hui-Chun Irene Su, University of California, San Diego:

Primary Outcome Measures:
  • Risk of infertility [ Time Frame: Annually up to 10 years ]
    Participants will be assessed for infertility on average each year from age 18 to 51, the age of natural menopause.


Secondary Outcome Measures:
  • Time to pregnancy [ Time Frame: Annually up to 10 years ]

Biospecimen Retention:   Samples Without DNA
Dried blood spots

Estimated Enrollment: 500
Study Start Date: May 2011
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
Young female cancer survivors

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Young women ages 18-44 who have been diagnosed with cancer or exposed to cancer treatment
Criteria

Inclusion Criteria:

  • Diagnosed with cancer or exposure to cancer treatment
  • English speaking
  • Ability to consent to the study
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01843140


Contacts
Contact: Samantha C Bailey 858-822-0768 ayastudy.ucsd@gmail.com

Locations
United States, California
UCSD Moores Cancer Center Recruiting
La Jolla, California, United States, 92093
Contact: Samantha C Bailey    858-822-0768    ayastudy.ucsd@gmail.com   
Sponsors and Collaborators
University of California, San Diego
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hui-Chun Irene Su, Assistant Professor of Reproductive Medicine, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01843140     History of Changes
Other Study ID Numbers: FIRST
First Submitted: July 26, 2012
First Posted: April 30, 2013
Last Update Posted: May 16, 2016
Last Verified: May 2016

Keywords provided by Hui-Chun Irene Su, University of California, San Diego:
cancer
fertility preservation
infertility
pregnancy