NCT02430103Active, not recruiting
Study of Preservation of Ovarian Reserve During Chemotherapy for Young Breast Cancer Patients
Effect of Goserelin on the Protection of Ovarian Reserve During (Neo)Adjuvant Chemotherapy for Young Breast Cancer Patients: A Prospective Cohort Trial
Source: ClinicalTrials.gov · Last updated 12 Dec 2024
Brief summary (registry, in English)
The purpose of this study is to assess efficacy of gonadotropin-releasing hormone agonist (goserelin) on the preservation of ovarian reserve function in young breast cancer patients treated with (neo)adjuvant chemotherapy by serial measuring ovarian reserve markers (AMH and AFC.etc) before and after chemotherapy and long-term pregnancy outcomes. Meanwhile, to evaluate the safety of this protective approach in young breast cancer patients by disease-free survival (DFS) and overall survival (OS) outcomes.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 349 (actual)
- First submitted
- 6 Apr 2015
- Start date
- 25 Dec 2015
- Primary completion date
- 31 Dec 2023
- Lead sponsor
- Peking University People's Hospital
- Diseases
- Ovarian cancer
- NCT number
- NCT02430103
What you commit to
- Study type: Observational
- Participants enrolled: 349
- From 25 Dec 2015 to the primary completion date, 31 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior chemotherapy
- Bilateral oophorectomy or ovarian irradiation before enrollment
- GnRHa -containing adjuvant endocrine therapy
Other illness
- History of other cancers
Other
- Any of the following is regarded as a criterion for exclusion from the study:
- Pregnancy or lactation
- Oral contraceptives before enrollment
Who the study is looking for
- For inclusion in the study patients must fulfil all of the following criteria:
- Aged 45 years or younger
- Have regular menstrual cycle
- Newly diagnosed early-stage breast cancer (stages I to III)
- Planned (neo)adjuvant chemotherapy
- Signed informed consent document on file
Age in the registry: 18 years to 45 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University People's Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.