Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    Ovarian Reserve | Ireland
Previous Study | Return to List | Next Study

Ovarian Reserve in Premenopausal Breast Cancer

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01726322
Recruitment Status : Active, not recruiting
First Posted : November 14, 2012
Last Update Posted : October 14, 2020
Sponsor:
Information provided by (Responsible Party):
Cancer Trials Ireland

Tracking Information
First Submitted Date November 9, 2012
First Posted Date November 14, 2012
Last Update Posted Date October 14, 2020
Actual Study Start Date September 2012
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 11, 2018)
Alteration of hormone levels in premenopausal patients receiving adjuvant or neo-adjuvant chemotherapy for breast cancer [ Time Frame: AMH levels will be taken at specified intervals until 3 years post chemotherapy ]
To determine alteration of hormone levels in premenopausal patients receiving adjuvant or neo-adjuvant chemotherapy for breast cancer
Original Primary Outcome Measures
 (submitted: November 9, 2012)
Change of AMH levels from before starting chemotherapy to predefined intervals concluding at 6 months post completion of chemotherapy [ Time Frame: AMH levels will be taken at specified intervals until 6 months post chemotherapy (5 blood samples collected) ]
Change History
Current Secondary Outcome Measures
 (submitted: October 11, 2018)
  • Comparative ovarian toxicity of differing neo-adjuvant/ adjuvant chemotherapy regimens [ Time Frame: up to 3 years post chemotherapy ]
    To evaluate the comparative ovarian toxicity of differing neo-adjuvant/ adjuvant chemotherapy regimens
  • Correlation between CIA and depletion of ovarian follicular reserve. [ Time Frame: up to 3 years post chemotherapy ]
    To assess the correlation between CIA and depletion of ovarian follicular reserve.
  • Correlation between changes in hormone levels during chemotherapy and the quality of life of premenopausal breast cancer patients [ Time Frame: up to 3 years post chemotherapy ]
    To determine the correlation between changes in hormone levels during chemotherapy and the quality of life of premenopausal breast cancer patients
  • Efficacy of GNRH agonists in preservation of ovarian follicles in premenopausal women treated with adjuvant or neo-adjuvant chemotherapy for breast cancer [ Time Frame: up to 3 years post chemotherapy ]
    To determine the efficacy of GNRH agonists in preservation of ovarian follicles in premenopausal women treated with adjuvant or neo-adjuvant chemotherapy for breast cancer (administration of GNRH agonists is dependent on the treating oncologist's judgment of the patient's case and prac-tices and is not to be influenced by study participation).
Original Secondary Outcome Measures
 (submitted: November 9, 2012)
Frequency of chemotherapy induced amenorrhea in patients treated with and without GNRH agonists. [ Time Frame: up to 6 months post chemotherapy ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Ovarian Reserve in Premenopausal Breast Cancer
Official Title A Study to Determine Alteration of Hormone Levels in Premenopausal Patients Receiving Adjuvant or Neo-adjuvant Chemotherapy for Breast Cancer
Brief Summary This is a translational, mutlicentre study. The aim of this study is to determine whether pre-treatment levels of hormones predict ovarian follicular reserve post adjuvant or neoadjuvant chemotherapy for breast cancer and chemotherapy induced amenorrhea.
Detailed Description It is proposed that levels of AMH and inhibin A and B measured will give an indication of the residual ovarian reserve in women with breast cancer treated with chemotherapy. In addition, AMH might give an indication of the possible efficacy of GNRH agonists in fertility preservation and the effect on ovarian follicular reserve using different adjuvant chemotherapy regimens. Those likely to be offered GNRH agonists are younger women with no children and a wish to have some in the future. Older women who have completed their families are less likely to be offered a GNRH agonist.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood, salivary samples and hair samples.
Sampling Method Non-Probability Sample
Study Population Premenopausal breast cancer patients who are to receive chemotherapy
Condition
  • Premenopausal Breast Cancer
  • Breast Cancer
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: November 9, 2012)
250
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 2023
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Documented histological diagnosis of invasive breast cancer
  2. Patient due to be treated with chemotherapy (neoadjuvant or adjuvant)*
  3. Female patients aged between 18 and 50 years
  4. Premenopausal status as defined by a hormone profile within the pre-menopausal range as defined by local lab

    OR The patient's last menstrual period had to be within the last 180 days

    OR An IUD is used for contraception.

  5. Ability to provide written informed consent

    • Patients treated with GNRH agonist or adjuvant Herceptin or participating in other clinical trials are also eligible

Exclusion Criteria:

  1. Patients with hypothalamic/pituitary disorder
  2. History of ovarian tumour
  3. Current pregnancy
Sex/Gender
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Ireland
Removed Location Countries  
 
Administrative Information
NCT Number NCT01726322
Other Study ID Numbers CTRIAL-IE (ICORG) 10-16
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Cancer Trials Ireland
Study Sponsor Cancer Trials Ireland
Collaborators Not Provided
Investigators Not Provided
PRS Account Cancer Trials Ireland
Verification Date October 2020