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NCT06904365 | NOT YET RECRUITING | Uterine Cancer

Ovarian-Sparing Adaptive Radiotherapy in Young Adult Women
Sponsor:

Washington University School of Medicine

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 premenopausal and at a high risk of premature ovarian failure from radiotherapy. Premature ovarian failure carries significant cardiac, musculoskeletal, sexual, and psychosocial morbidity. Ovarian transposition carries variable success rates, is not readily accessible to the general population, and can still be at risk of clinically significant radiotherapy doses. There is an unmet need for innovative techniques to protect ovarian function.

Condition or disease

Uterine Cancer

Rectal Cancer

Colon Cancer

Breast Cancer

Lung Cancer

Sarcoma

Cervix Cancer

Head and Neck Cancer

Anal Cancer

Liver Cancer

Gastric Cancer

Bladder Cancer

Intervention/treatment

HyperSight cone beam computed tomography (CBCT) scan

ETHOS 2.0

Study Type : OBSERVATIONAL
Estimated Enrollment : 10 participants
Official Title : Ovarian-Sparing Adaptive Radiotherapy in Young Adult Women (OvAR-Y): an In-Silico Feasibility Trial
Actual Study Start Date : 2025-04-01
Estimated Primary Completion Date : 2026-04-15
Estimated Study Completion Date : 2026-04-15

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 50 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * 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 Criteria
  • * 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
Ovarian-Sparing Adaptive Radiotherapy in Young Adult Women

Location Details

NCT06904365

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How to Participate

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Locations

Not yet recruiting

United States, Missouri

Washington University School of Medicine

Saint Louis, Missouri, United States, 63110