Anti-Mullerian Hormone Study. ICORG 10-16, V2

This study is currently recruiting participants.
Verified January 2014 by ICORG- All Ireland Cooperative Oncology Research Group
Sponsor:
Information provided by (Responsible Party):
ICORG- All Ireland Cooperative Oncology Research Group
ClinicalTrials.gov Identifier:
NCT01726322
First received: November 9, 2012
Last updated: January 22, 2014
Last verified: January 2014
  Purpose

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).

Secondary Objective

  • 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.

Condition
Premenopausal Breast Cancer
Breast Cancer

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by ICORG- All Ireland Cooperative Oncology Research Group:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 250
Study Start Date: September 2012
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 42 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Premenopausal breast cancer patients who are to receive chemotherapy

Criteria

Inclusion Criteria:

  1. Documented histological diagnosis of invasive breast cancer
  2. Patient due to be treated with chemotherapy (neoadjuvant or adjuvant)[Patients treated with GNRH agonist or adjuvant Herceptin or participating in other clinical trials are also eligible]
  3. Female patients aged between 18 and 42 years
  4. Premenopausal status as defined by a hormone profile (FSH, LH, E2 within the pre-menopausal range as defined by local lab).

    OR

    -The last menstrual period had to be within 180 days

    OR

    -An IUD is used for contraception

  5. Karnofsky score greater or equal to 70
  6. Ability to provide written informed consent

Exclusion Criteria:

  1. Patients with hypothalamic/pituitary disorder
  2. History of ovarian tumour
  3. Current pregnancy (pregnancy test as per hospital standard prior to treatment)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01726322

Locations
Ireland
Our Lady of Lourdes Hospital Recruiting
Drogheda, Louth, Ireland, Co
Contact: Bryan Hennessy, Dr    01-8092010      
Principal Investigator: Bryan Hennessy, Dr         
Cork University Hospital Recruiting
Cork, Ireland
Contact: Contact Person    021-4546400      
Principal Investigator: Seamus O'Reilly, Dr         
Bon Secours Hospital Recruiting
Cork, Ireland
Contact: Contact Person    021-4542807      
Principal Investigator: Brian Bird, Dr         
St James Hospital Recruiting
Dublin, Ireland
Contact: Contact Person    01-4103000      
Principal Investigator: John Kennedy, Dr         
St Vincent's University Hospital Recruiting
Dublin, Ireland
Contact: Contact Person    01-2214000      
Principal Investigator: Janice Walshe, Dr         
The Adelaide & Meath Hospital, Dublin, Incorporating the National Children's Hospital Recruiting
Dublin, Ireland
Contact: Contact Person    01- 414 2000      
Principal Investigator: Janice Walshe, Dr         
Beaumont Hospital Recruiting
Dublin, Ireland, 9
Contact: Contact Person    01-8092373      
Principal Investigator: Oscar Breathnach, Dr         
Galway University Hospital Recruiting
Galway, Ireland
Contact: Contact Person    091-544805      
Principal Investigator: Maccon Keane, Dr         
Sligo General Hospital Recruiting
Sligo, Ireland
Contact: Contact Person    071- 9171111      
Principal Investigator: Michael Martin, Dr         
Waterford Regional Hospital Recruiting
Waterford, Ireland
Contact: Contact Person    051-848000      
Principal Investigator: Miriam O'Connor, Dr         
Sponsors and Collaborators
ICORG- All Ireland Cooperative Oncology Research Group
  More Information

No publications provided

Responsible Party: ICORG- All Ireland Cooperative Oncology Research Group
ClinicalTrials.gov Identifier: NCT01726322     History of Changes
Other Study ID Numbers: ICORG 10-16
Study First Received: November 9, 2012
Last Updated: January 22, 2014
Health Authority: Ireland: Health Information and Quality Authority

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on April 22, 2014