Breast CancerAMHpilotNCT07896772
Anti-Müllerian Hormone in Breast Cancer Clinical Practice
An observational study of Breast Cancer, run by Masaryk Memorial Cancer Institute at 1 site in Czechia.
Trial summary
This study aims to evaluate serum anti-Müllerian hormone (AMH) levels and complementary hormonal parameters, including follicle-stimulating hormone (FSH), estradiol, thyroid-stimulating hormone (TSH), and free thyroxine (fT4), in women with breast cancer and healthy female controls. Read more about this study
- Who is it for?
- Ages 20 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- How many people
- 200 participants
- Where
- 1 siteCzechia
- Study dates
- 20 Nov 2025to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 20 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: The study population will consist of women aged 20-55 years, including patients with breast cancer at different stages of disease and treatment and healthy female volunteers. Breast cancer patients will be identified during routine clinical care, while healthy volunteers will be recruited on a voluntary basis.
Who may be able to join
- Women aged 20-55 years.
- Patients with a diagnosis of breast cancer at any of the specified stages of treatment or follow-up, or healthy female volunteers.
- Blood sampling as part of routine clinical care (breast cancer patients) or willingness to undergo a single blood draw (healthy volunteers).
Who cannot join
- Inability or unwillingness to participate in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Milos Holanek, Ph.D. contact
Czechia1 site, 1 recruiting
- Recruiting
Masaryk Memorial Cancer Institute
Brno, 65653
Iveta Selingerova, Ph.D., +420543136720, iveta.selingerova@mou.cz
About this study
This study aims to evaluate serum anti-Müllerian hormone (AMH) levels and complementary hormonal parameters, including follicle-stimulating hormone (FSH), estradiol, thyroid-stimulating hormone (TSH), and free thyroxine (fT4), in women with breast cancer and healthy female controls.
The study will generate preliminary real-world data on AMH and related hormonal parameters and assess the feasibility of implementing AMH testing into routine clinical practice.
Read the detailed description
The study will include women aged 20-55 years. Patients with breast cancer will be enrolled at different stages of their disease and treatment, including newly diagnosed treatment-naive patients, patients who have completed chemotherapy, patients receiving endocrine therapy without prior chemotherapy, and patients undergoing follow-up after treatment.
In patients with breast cancer, hormonal measurements will be obtained as part of routine clinical care, based on the treating physician's decision. No additional study-specific blood sampling or interventions will be performed. Relevant clinical data will be collected from medical records.
Healthy volunteers will undergo a single blood sampling procedure and complete a brief questionnaire covering gynecological history, smoking status, and body mass index (BMI).
The hormonal assessment will include serum anti-Müllerian hormone (AMH), follicle-stimulating hormone (FSH), estradiol, thyroid-stimulating hormone (TSH), and free thyroxine (fT4).
The collected data will be used to describe hormonal profiles in both study populations and assess the feasibility of routine AMH testing in clinical practice. The findings may provide preliminary data for future research on the clinical utility of AMH in women with breast cancer.
- Conditions
- Breast Cancer
- Keywords
- AMH, Anti-Müllerian Hormone, Hormonal Profile, Ovarian Reserve, Breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Breast Cancer Patients | Women aged 20-55 years with breast cancer at different stages of disease and treatment, including newly diagnosed treatment-naive patients, patients who have completed chemotherapy, patients receiving endocrine therapy without prior chemotherapy, and patients undergoing follow-up after treatment. | |
| Healthy Controls | Healthy women aged 20-55 years without a history of breast cancer. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Anti-Müllerian Hormone (AMH) Levels
Serum AMH concentrations will be measured in women with breast cancer at different stages of treatment and in healthy female controls. The distribution of AMH levels will be described in both study populations.
Measured: Baseline (At the time of blood sampling)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start20 Nov 2025
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Masaryk Memorial Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07896772
- Sponsor's protocol ID
- A53/25
- Acronym
- AMHpilot
- Status last verified
- Oct 2026
- First submitted
- 20 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-Müllerian Hormone in Breast Cancer Clinical Practice
- ClinicalTrials.gov ID
- NCT07896772
- Acronym / sponsor ID
- AMHpilot / A53/25
- Conditions
- Breast Cancer
- Keywords
- AMH, Anti-Müllerian Hormone, Hormonal Profile, Ovarian Reserve, Breast cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Masaryk Memorial Cancer InstituteUniversity, hospital or other
- Study start
- 20 Nov 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 27 Oct 2026 (actual)
- 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.
This study aims to evaluate serum anti-Müllerian hormone (AMH) levels and complementary hormonal parameters, including follicle-stimulating hormone (FSH), estradiol, thyroid-stimulating hormone (TSH), and free thyroxine (fT4), in women with breast cancer and healthy female controls.
The study will generate preliminary real-world data on AMH and related hormonal parameters and assess the feasibility of implementing AMH testing into routine clinical practice.
Detailed description
The study will include women aged 20-55 years. Patients with breast cancer will be enrolled at different stages of their disease and treatment, including newly diagnosed treatment-naive patients, patients who have completed chemotherapy, patients receiving endocrine therapy without prior chemotherapy, and patients undergoing follow-up after treatment.
In patients with breast cancer, hormonal measurements will be obtained as part of routine clinical care, based on the treating physician's decision. No additional study-specific blood sampling or interventions will be performed. Relevant clinical data will be collected from medical records.
Healthy volunteers will undergo a single blood sampling procedure and complete a brief questionnaire covering gynecological history, smoking status, and body mass index (BMI).
The hormonal assessment will include serum anti-Müllerian hormone (AMH), follicle-stimulating hormone (FSH), estradiol, thyroid-stimulating hormone (TSH), and free thyroxine (fT4).
The collected data will be used to describe hormonal profiles in both study populations and assess the feasibility of routine AMH testing in clinical practice. The findings may provide preliminary data for future research on the clinical utility of AMH in women with breast cancer.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breast Cancer Patients | – | –Women aged 20-55 years with breast cancer at different stages of disease and treatment, including newly diagnosed treatment-naive patients, patients who have completed chemotherapy, patients receiving endocrine therapy without prior chemotherapy, and patients undergoing follow-up after treatment. |
| Healthy Controls | – | –Healthy women aged 20-55 years without a history of breast cancer. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study population will consist of women aged 20-55 years, including patients with breast cancer at different stages of disease and treatment and healthy female volunteers. Breast cancer patients will be identified during routine clinical care, while healthy volunteers will be recruited on a voluntary basis.
Key inclusion criteria (3 listed)
- Women aged 20-55 years.
- Patients with a diagnosis of breast cancer at any of the specified stages of treatment or follow-up, or healthy female volunteers.
- Blood sampling as part of routine clinical care (breast cancer patients) or willingness to undergo a single blood draw (healthy volunteers).
Key exclusion criteria (1 listed)
- Inability or unwillingness to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Serum Anti-Müllerian Hormone (AMH) Levels
Time frame: Baseline (At the time of blood sampling)
Serum AMH concentrations will be measured in women with breast cancer at different stages of treatment and in healthy female controls. The distribution of AMH levels will be described in both study populations.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
Milos Holanek, Ph.D. contact
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, run by Masaryk Memorial Cancer Institute at 1 site in Czechia.
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 3 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 27 Oct 2026. 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 Czechia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Iveta Selingerova, Ph.D. (+420543136720, iveta.selingerova@mou.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Anti-Müllerian Hormone (AMH) Levels (time frame: Baseline (At the time of blood sampling)). 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 27 Oct 2026.