Anti-Mullerian Hormone Study. ICORG 10-16, V2
Primary Objective :
To determine whether pre-treatment levels of anti-mullerian hormone predicts ovarian follicular reserve post adjuvant or neoadjuvant chemotherapy for breast cancer and chemotherapy induced amenorrhea (CIA).
- To evaluate the comparative ovarian toxicity of differing neo-adjuvant/ adjuvant chemotherapy regimens.
- To assess the correlation between CIA and depletion of ovarian follicular reserve.
- To partly externally validate preceding studies of anti-mullerian hormone levels in patients receiving neo-adjuvant/ adjuvant chemotherapy for breast cancer.
- 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 practices and is not to be influenced by study participation.
Premenopausal Breast Cancer
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||A Study to Determine Alteration of Anti-mullerian Hormone (AMH) Concentrations in Premenopausal Patients Receiving Adjuvant or Neo-adjuvant Chemotherapy for Breast Cancer|
- Change of AMH levels from before starting chemotherapy to predefined intervals concluding at 3 years post completion of chemotherapy [ Time Frame: AMH levels will be taken at specified intervals until 3 years post chemotherapy ] [ Designated as safety issue: No ]
- Frequency of chemotherapy induced amenorrhea in patients treated with and without GNRH agonists. [ Time Frame: up to 3 years post chemotherapy ] [ Designated as safety issue: No ]
|Study Start Date:||September 2012|
|Estimated Primary Completion Date:||September 2018 (Final data collection date for primary outcome measure)|
Type of Study: Translational Study
Sample Type: A 10mL blood sample will be collected in red vacutainer tubes (no anticoagulant, no gel) from each patient at the designated time points +/- 7days. Blood should preferably be collected in the follicular phase of the menstrual cycle.
Time of Sample procurement:
- 1st Sample: Pre-Chemotherapy (≤ 14 days pre-treatment)
- 2nd Sample: e.g. before cycle 3, if undergoing a 4 cycle regimen or before cycle 4 in a 6 cycle regimen. (If the chemotherapy regimen changes following the commencement of chemotherapy &/or after surgery, then blood samples will be taken at the time points determined by the original plan i.e. if a patient was to have 6 cycles of chemotherapy and this was then changed to 4 cycles samples will be taken before cycle 4)
- 3rd sample: 3 weeks following the last dose of chemotherapy
- 4th sample: 3 months following the last dose of chemotherapy
- 5th sample: 6 months following the last dose of chemotherapy
- 6th sample: 1 year following the last dose of chemotherapy
- 7th sample: 2 years following the last dose of chemotherapy
- 8th sample: 3 years following the last dose of chemotherapy
Patient's menstrual status including the commencement date of last menstrual period or the use of Intra Uterine Devices (IUD) and FSH, LH and E2 levels will be documented on the Baseline Assessment CRF.
FSH, LH and E2 levels will also be measured at each time point and documented on the Follow-up Assessment CRF.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01726322
|Bracken Rd, Sandyford Industrial Estate, Dublin 18, Ireland|
|Contact: Jennifer Westrup 01 293 6600|
|Contact: Dr Jennifer Westrup|
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