Status:
RECRUITING
Ovarian-Sparing Adaptive Radiotherapy in Young Adult Women
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
Varian Medical Systems
Conditions:
Uterine Cancer
Rectal Cancer
Eligibility:
FEMALE
18-50 years
Brief Summary
Female patients with early onset (\<50 years old) pelvic malignancies such as uterine and rectal cancers are rising in incidence, which often requires pelvic radiation; many of these patients are prem...
Eligibility Criteria
Inclusion
- Biologic female
- Age between 18 and 50 years old (inclusive)
- Clinically premenopausal (defined as having active, regular menstruation without vasomotor symptoms)
- At least one of two ovaries readily visualized on diagnostic CT or MR imaging as confirmed by radiologist
- Planning to receive radiation therapy (for any indication)
- Ability to understand and willingness to sign an IRB-approved written informed consent document.
Exclusion
- Prior pelvic radiation
- Prior cancer therapies that are known to impact ovarian function
- Prior diagnosis of ovarian insufficiency/failure or menopause
- Clinically peri- or post-menopausal
- For patients \> 45 years old, if there is a clinical history of vasomotor symptoms OR irregular periods, then the patient must be excluded.
- For patients ≤ 45 years old, if there is a history of vasomotor symptoms consistent with menopause OR irregular menstruation for ≥3 months OR recent changes in their menstrual cycle \> 14 days, then the patient must be excluded.
- Surgically removed or transposed ovaries
- Pregnant and/or breastfeeding
Key Trial Info
Start Date :
April 8 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 15 2026
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06904365
Start Date
April 8 2025
End Date
April 15 2026
Last Update
September 22 2025
Active Locations (1)
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1
Washington University School of Medicine
St Louis, Missouri, United States, 63110