Breast Cancer SurvivorNCT01062542
Assessment of Ovarian Reserve in Female Cancer Survivors
An observational study of Breast Cancer Survivor and Pediatric Cancer Survivor, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Chemotherapy can damage the ovaries and cause premature menopause. In women treated before the age of 40 years, menopause does not usually occur. We have very little information about the impact of chemotherapy on ovarian function in this particular group of women. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer Survivor, Pediatric Cancer Survivor
- What is being tested?
- Blood Draw and Ultrasound
- Type of treatment
- Surgery or procedure
- How many people
- 210 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2008to 2 Mar 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Patients are selected from their primary care clinic.
Who may be able to join
- Breast Cancer Survivors
- histological confirmation of breast cancer
- received chemotherapy +/- radiotherapy with curative intent
- age 40 years or less at the time of diagnosis
- currently age 50 years or less
- currently disease free.
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- Pediatric Cancer Survivors
- Received chemotherapy and / or radiotherapy with curative intent.
- Currently age 18 years and older.
- Currently premenopausal and attained at age 50 years or less.
- Currently disease free.
- Diagnosed with sarcoma or Hodgkin's disease or leukemia at 30 years or less.
- Control group 1. Premenopausal.
Who cannot join
- Breast Cancer Survivors
- treatment for malignancy other than breast cancer, involving chemotherapy or radiation to the ovaries/pelvis.
- any cancer recurrence
- hysterectomy/oophorectomy.
- Pediatric Cancer Survivors
- Hysterectomy / oophorectomy.
Show all 10Show fewer
- Pelvic Radiation.
- Control group
- Received chemotherapy and / or pelvic radiation therapy,
- hysterectomy/oophorectomy.
Trial locations and contacts
1 site in 1 country.
Canada1 site
University Health Network, Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
About this study
Official title: Fertility in Female Cancer Survivors - Novel Assessment of Ovarian Reserve
Chemotherapy can damage the ovaries and cause premature menopause. In women treated before the age of 40 years, menopause does not usually occur. We have very little information about the impact of chemotherapy on ovarian function in this particular group of women. In this study, we will check hormone blood tests and ultrasound tests of the ovaries to measure the reserve of eggs left in the ovaries after treatment in young survivors of breast cancer and childhood cancer. We will do the same tests in our comparison group. We can use these results to estimate the reduction in fertility in young cancer survivors.
Read the detailed description
As women across North America and Europe increasingly delay childbirth, fertility preservation is emerging as an important issue among young breast cancer patients. The dramatic increase in survival for the major pediatric cancers in the last 50 years has resulted in an expanding population of childhood cancer survivors. The information currently available to counsel these patients about the impact of treatment on their fertility is inadequate. A significant degree of subfertility can exist prior to the onset of frank ovarian failure, and current studies do not address this.
This study will adopt new technologies that have revolutionized the evaluation of female fertility to assess ovarian function in young breast cancer survivors. The results will provide new, more accurate and clinically useful information to patients and physicians about the impact of cancer therapy on fertility. The results have the potential to influence clinical decisions regarding cancer treatment, and the use of assisted reproductive technologies for contemporary patients and survivors. Further, insofar as treatment advances are designed to improve disease control while reducing toxicity, these results may serve as the basis for better understanding the toxicity of modern therapy and provide opportunities for improvement.
- Conditions
- Breast Cancer Survivor, Pediatric Cancer Survivor
- Being tested
- Blood Draw and Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Draw and UltrasoundProcedure or surgery
Patients will have a Blood sample taken to check hormone levels. Patients will also have an ultrasound test done to examine the ovaries. The ultrasound test is done by inserting a cylindrical probe into the vagina. The test has to be done this way to measures the ovaries accurately.
| Study group | Role | What they receive |
|---|---|---|
| Breast Cancer Survivors | Not described Receives: Procedure: Blood Draw and Ultrasound | |
| Pediatric Cancer Survivors | Not described Receives: Procedure: Blood Draw and Ultrasound | |
| Control group | Not described Receives: Procedure: Blood Draw and Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
To estimate the immediate decline in ovarian reserve in young breast cancer patients receiving chemotherapy using new biochemical and biophysical measures
Measured: 3 years
To model the decline in ovarian reserve with advancing age after cancer therapy in both young breast cancer and childhood cancer survivors and compare this with the decline seen in controls
Measured: 3 years
To develop methods to estimate the time to onset of menopause, and the time before natural or assisted conception such as in vitro fertilization become less successful
Measured: 3 years
Secondary outcomes (2)
To evaluate the changes in ovarian function associated with specific chemotherapy regimens.
Measured: 3 years
To determine the time-to-pregnancy and cumulative incidence of pregnancy among young cancer survivors attempting pregnancy after treatment.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2010 (estimated)
- Study startSep 2008
- Primary completionMar 2018
- Study completion2 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer SurvivorStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Princess Margaret Hospital, Canada, Canadian Breast Cancer Foundation
- Responsible party
- Sponsor
- Investigators
- David Hodgson, MD, Principal investigator, University Health Network, Princess Margaret Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01062542
- Sponsor's protocol ID
- UHN REB 08-0115-B
- Status last verified
- Jun 2018
- First submitted
- 21 Jan 2010
- Last updated
- 12 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fertility in Female Cancer Survivors - Novel Assessment of Ovarian Reserve
- ClinicalTrials.gov ID
- NCT01062542
- Acronym / sponsor ID
- UHN REB 08-0115-B
- Conditions
- Breast Cancer Survivor, Pediatric Cancer Survivor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Princess Margaret Hospital, Canada, Canadian Breast Cancer Foundation
- Study start
- Sep 2008
- Primary completion
- Mar 2018 (actual)
- Study completion
- 2 Mar 2018 (actual)
- First posted
- 4 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chemotherapy can damage the ovaries and cause premature menopause. In women treated before the age of 40 years, menopause does not usually occur. We have very little information about the impact of chemotherapy on ovarian function in this particular group of women. In this study, we will check hormone blood tests and ultrasound tests of the ovaries to measure the reserve of eggs left in the ovaries after treatment in young survivors of breast cancer and childhood cancer. We will do the same tests in our comparison group. We can use these results to estimate the reduction in fertility in young cancer survivors.
Detailed description
As women across North America and Europe increasingly delay childbirth, fertility preservation is emerging as an important issue among young breast cancer patients. The dramatic increase in survival for the major pediatric cancers in the last 50 years has resulted in an expanding population of childhood cancer survivors. The information currently available to counsel these patients about the impact of treatment on their fertility is inadequate. A significant degree of subfertility can exist prior to the onset of frank ovarian failure, and current studies do not address this.
This study will adopt new technologies that have revolutionized the evaluation of female fertility to assess ovarian function in young breast cancer survivors. The results will provide new, more accurate and clinically useful information to patients and physicians about the impact of cancer therapy on fertility. The results have the potential to influence clinical decisions regarding cancer treatment, and the use of assisted reproductive technologies for contemporary patients and survivors. Further, insofar as treatment advances are designed to improve disease control while reducing toxicity, these results may serve as the basis for better understanding the toxicity of modern therapy and provide opportunities for improvement.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Breast Cancer Survivors | – | Procedure: Blood Draw and Ultrasound |
| Pediatric Cancer Survivors | – | Procedure: Blood Draw and Ultrasound |
| Control group | – | Procedure: Blood Draw and Ultrasound |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients are selected from their primary care clinic.
Key inclusion criteria (13 listed)
- Breast Cancer Survivors
- Pediatric Cancer Survivors
- Control group 1. Premenopausal.
Key exclusion criteria (10 listed)
- Breast Cancer Survivors
- Pediatric Cancer Survivors
- Control group
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood Draw and UltrasoundPatients will have a Blood sample taken to check hormone levels. Patients will also have an ultrasound test done to examine the ovaries. The ultrasound test is done by inserting a cylindrical probe into the vagina. The test has to be done this way to measures the ovaries accurately. | Procedure or surgery | Breast Cancer Survivors, Control group, Pediatric Cancer Survivors |
Primary outcome
To estimate the immediate decline in ovarian reserve in young breast cancer patients receiving chemotherapy using new biochemical and biophysical measures
Time frame: 3 years
To model the decline in ovarian reserve with advancing age after cancer therapy in both young breast cancer and childhood cancer survivors and compare this with the decline seen in controls
Time frame: 3 years
To develop methods to estimate the time to onset of menopause, and the time before natural or assisted conception such as in vitro fertilization become less successful
Time frame: 3 years
2 secondary outcomes
To evaluate the changes in ovarian function associated with specific chemotherapy regimens.
Time frame: 3 years
To determine the time-to-pregnancy and cumulative incidence of pregnancy among young cancer survivors attempting pregnancy after treatment.
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Hodgson, MD principal investigator
University Health Network, Princess Margaret Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer Survivor and Pediatric Cancer Survivor, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To estimate the immediate decline in ovarian reserve in young breast cancer patients receiving chemotherapy using new biochemical and biophysical measures (time frame: 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2018.