ClinicalTrials.gg
CompletedNCT06904365OvAR-YUpdated Oct 29, 2026

Ovarian-Sparing Adaptive Radiotherapy in Young Adult Women

An observational study in Uterine Cancer, Rectal Cancer and Colon Cancer, sponsored by Washington University School of Medicine. Completed at 1 site in United States. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-10-29.

Primary conditionUterine Cervical NeoplasmsRegistry: Uterine NeoplasmsReclassifiedWhy we changed it
Registry
Uterine Neoplasms — the first condition term the registry derived for this study.
ClinicalTrials.gg
Uterine Cervical Neoplasms
Why
  1. The study's listed conditions name Uterine Cervical Neoplasms, a narrower term within Uterine Neoplasms.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Washington University School of Medicine · Observational

Updated Oct 29, 2026Now CompletedPrimary completion moved+2 moreGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
11
Ages
18 Years to 50 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 19 studies in Uterine Cervical Neoplasms by Washington University School of Medicine — 4 open to participants now, 4 under way, none of them phase 3. Uterine Cervical Neoplasms · Washington University School of Medicine.

Started
2025
with 2 others
Observational
Only one
of the 19
Registered
18th of 19
by date

Among the 19 studies in Uterine Cervical Neoplasms by Washington University School of Medicine, this one is one of 3 that started in 2025, is the only observational one, and was the 18th registered.

By phase

19 studies; the count open now beside each. This study's row is marked.

No phase10 · 2 open
Phase 24 · 1 open
Phase 13 · 0 open
Observationalthis study1 · 0 open
Phase 1/21 · 1 open

By the year they started

First in 2003; this study’s year is marked. 3 started in 2025.

Size and results

Median enrollment 26 across the 18 interventional studies, 11 across the 1 observational. Of the 13 that completed or were terminated, 4 (31%) have results posted.

Was this useful?
Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 19 studies in Uterine Cervical Neoplasms by Washington University School of Medicine, or all of them as a file.
02

Study 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.

03

Conditions studied

  • 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

Keywords

  • Young onset colorectal cancer
  • Early onset
  • Pre-menopausal
  • Ovarian sparing radiation
04

In context

Uterine Cervical Neoplasms Reclassified

2,366 studies on the registry are indexed under Uterine Cervical Neoplasms; 677 are open to participants now.

This study's enrollment of 11 is below the median of 225 across 529 observational studies indexed under Uterine Cervical Neoplasms.

Browse Uterine Cervical Neoplasms studies →

Lead sponsor

Washington University School of Medicine is the lead sponsor of 1,803 studies on the registry; 271 are open to participants now.

Of its 329 completed or terminated interventional studies of FDA-regulated products, 216 (66%) have results posted.

Compared within Uterine Cervical Neoplasms, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Uterine Neoplasms. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

This study will enroll patients at Siteman Cancer Center at Washington University School of Medicine.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 document.

Exclusion criteria

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

    • 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

06

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
11 participants (actual)
Patient registry
No

Groups and cohorts

  • Ovarian-Sparing Adaptive Radiotherapy

    A 25 Gy / 5 fx rectal plan for all patients, irrespective of their primary malignancy, will be created as per institutional standards. Patients may undergo treatment on any radiation therapy machine but will have their pelvis images on a HyperSight CBCT machine after consent while they receive their treatment. In general, patients will be imaged with 2 CBCTs approximately 10 minutes apart, each imaging session / day. However, only one CBCT per treatment session is required, and a patient may have between 1 to 10 scans total throughout 1 to 5 imaging sessions. In general, if ovaries are well visualized then only 1 or 2 imaging sessions will be completed.

    Device: HyperSight cone beam computed tomography (CBCT) scan · Device: ETHOS 2.0

Interventions

  • DeviceHyperSight cone beam computed tomography (CBCT) scan

    HyperSight is a novel onboard imaging platform with a rapid-acquisition high-quality CBCT imager capable of acquiring images sufficient for simulation and treatment.

    Also known as: CBCT

  • DeviceETHOS 2.0

    ETHOS 2.0, an artificial intelligence treatment planning system, will be utilized in an emulator to create SCRT plans to determine the feasibility of clinically significant ovarian dose reductions in-silico.

07

What researchers measure

Primary outcomes

  1. Incidence of ovarian visualization

    Defined as being able to delineate at least one ovary (if only one is visible, must be the same ovary) for ≥60% of CBCT sessions per patient.

    Time frame: Estimated to be 5 days

Secondary outcomes

  1. Incidence of dosimetrically sparing one or both ovaries from a functionally ablative radiation dose

    Defined as maintaining a cumulative \>95% coverage of planned tumor volume (PTV) with 95% of the prescription dose (25 Gy/5 fx) while delivering no more 6 Gy to the ovaries per patient. If only one ovary can meet constraints it must be the same ovary over all fractions.

    Time frame: Estimated to be 5 days

08

Study locations

1 site
  • Washington University School of Medicine
    St Louis, Missouri 63110, United States
09

References and documents

Individual participant data

Plan to share: Yes — Data will be shared if research proposal is submitted and approved by Principal Investigator.

Access criteria: Email Principal Investigator with research proposal.

10

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2025 to primary completion in Oct 2026, 18 months.

Of 189 non-industry observational studies under Uterine Cervical Neoplasms, half reached primary completion within 58 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 158. This study's 18 months is below that.

Counting every sponsor, half of 213 studies reached it within 58 months; a quarter within 28 and three quarters within 158.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 24, 2025
First posted
Apr 1, 2025
StartActual
Apr 8, 2025
Primary completionActual
Oct 14, 2026
CompletionActual
Oct 14, 2026
Last update
Oct 29, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Recruiting→Completed
changed Oct 29, 2026
Primary completion
Oct 31, 2026→Oct 14, 2026 (actual)
Oct 29, 2026
Study completion
Oct 31, 2026→Oct 14, 2026 (actual)
Oct 29, 2026
Show all 1 update
  1. Oct 29, 2026
    Recruiting→Completed
    Primary completion Oct 31, 2026→Oct 14, 2026 (now actual)
    Study completion Oct 31, 2026→Oct 14, 2026 (now actual)
    + 3 other changes: verification date, contact details and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

11

Registry details

Key details

Study ID
NCT06904365
Responsible party
Sponsor
First posted
Apr 1, 2025
Start date
Apr 8, 2025
Primary completion
Oct 14, 2026
Completion
Oct 14, 2026
Last update
Oct 29, 2026

Study contacts

Michael Waters, M.D., Ph.D.
principal investigator · Washington University School of Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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