RECRUITING

Ovarian-Sparing Adaptive Radiotherapy in Young Adult Women

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Ovarian-Sparing Adaptive Radiotherapy in Young Adult Women (OvAR-Y): an In-Silico Feasibility Trial

Quick Facts

Study Start:2025-04-08
Study Completion:2026-04-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06904365

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 50 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Biologic female
  2. * Age between 18 and 50 years old (inclusive)
  3. * Clinically premenopausal (defined as having active, regular menstruation without vasomotor symptoms)
  4. * At least one of two ovaries readily visualized on diagnostic CT or MR imaging as confirmed by radiologist
  5. * Planning to receive radiation therapy (for any indication)
  6. * Ability to understand and willingness to sign an IRB-approved written informed consent document.
  1. * Prior pelvic radiation
  2. * Prior cancer therapies that are known to impact ovarian function
  3. * Prior diagnosis of ovarian insufficiency/failure or menopause
  4. * Clinically peri- or post-menopausal
  5. * For patients \> 45 years old, if there is a clinical history of vasomotor symptoms OR irregular periods, then the patient must be excluded.
  6. * 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.
  7. * Surgically removed or transposed ovaries
  8. * Pregnant and/or breastfeeding

Contacts and Locations

Study Contact

Hyun Kim, M.D.
CONTACT
314-362-8567
kim.hyun@wustl.edu

Principal Investigator

Hyun Kim, M.D.
PRINCIPAL_INVESTIGATOR
Washington University School of Medicine

Study Locations (Sites)

Washington University School of Medicine
Saint Louis, Missouri, 63110
United States

Collaborators and Investigators

Sponsor: Washington University School of Medicine

  • Hyun Kim, M.D., PRINCIPAL_INVESTIGATOR, Washington University School of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-08
Study Completion Date2026-04-15

Study Record Updates

Study Start Date2025-04-08
Study Completion Date2026-04-15

Terms related to this study

Keywords Provided by Researchers

  • Young onset colorectal cancer
  • Early onset
  • Pre-menopausal
  • Ovarian sparing radiation

Additional Relevant MeSH Terms

  • 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