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NCT07419490 · ClinicalTrials.gov registry record · NA
Utero-ovarian Transposition in Patients With Pelvic Malignancies Undergoing Whole Pelvic Radiotherapy
A NA study of Colorectal (Colon or Rectal) Cancer and Pelvic Malignancies, sponsored by University of South Florida.
- Recruiting
- Registry status
- NA
- Development phase
- 26
- Enrollment target
- 1
- Study location
NCT07419490 is a NA study of Colorectal (Colon or Rectal) Cancer and Pelvic Malignancies that is actively recruiting participants, run by University of South Florida. The registered enrollment target is 26 participants. The trial reports 1 study location across 1 state.
The verdict
NCT07419490, a NA study of Colorectal (Colon or Rectal) Cancer and Pelvic Malignancies, is actively recruiting participants, sponsored by University of South Florida.
- RECRUITING
- Registry status
- NA
- Development phase
- 26 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is designed as a Phase I clinical trial enrolling female patients aged 18-40 years who have been diagnosed with pelvic malignancies requiring whole pelvic external radiation therapy (WPXRT) and who express interest in preserving fertility and ovarian function. The trial's primary objective is to assess the feasibility and safety of uterine and ovarian transposition (UOT). Premenopausal women under the age of 40 will undergo UOT using a novel minimally invasive approach. Feasibility and safety will be evaluated through standardized postoperative assessments, including: (A) success in mobilizing and repositioning the uterus, ovaries, and fallopian tubes while maintaining vascular integrity; (B) documentation of surgical complications; (C) monitoring the timeliness and adherence to planned WPXRT. To enhance safety and optimize outcomes, intraoperative imaging with indocyanine green fluorescence and Doppler ultrasonography will be employed. Short-term success will be defined by technical success in repositioning the uterus and ovaries with preserved vascular integrity, absence of major surgical complications, and timely initiation and completion of WPXRT. Long-term success will be evaluated by the preservation of fertility. The study's primary objective is also to evaluate surgical, reproductive, and quality-of-life outcomes following UOT. This objective will determine the procedure's efficacy in preserving ovarian and menstrual function and its potential to support future pregnancies. Endpoints include: (A) maintenance of normal premenopausal levels of FSH, LH, AMH, and estradiol at defined postoperative intervals; (B) assessment of menstrual timing, regularity, and characteristics to document return of ovulatory cycles; (C) evaluation of uterine integrity and reproductive potential using pelvic ultrasonography; (D) comprehensive evaluation of patient quality of life encompassing physical, emotional, sexual, and reproductive well-being. These measu
Conditions Studied
Interventions
- PROCEDURE Uteroovarian transposition
Study Locations (1)
Florida
- Tampa General Hospital - Tampa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2026-03-20 |
| Est. Completion | 2031-06 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07419490
The ClinicalTrials.gov registry entry for NCT07419490 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of South Florida, which has 252 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Colorectal (Colon or Rectal) Cancer appearing as the primary indexed condition, and to 1 intervention - of which Uteroovarian transposition is the first listed.
NCT07419490 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.
Frequently Asked Questions
What is clinical trial NCT07419490 about?
NCT07419490 is a clinical study titled "Utero-ovarian Transposition in Patients With Pelvic Malignancies Undergoing Whole Pelvic Radiotherapy". This study is designed as a Phase I clinical trial enrolling female patients aged 18-40 years who have been diagnosed with pelvic malignancies requiring whole pelvic external radiation therapy (WPXRT) and who express interest in preserving fertility and ovarian function. The trial's primary objecti...
What is the current status of trial NCT07419490?
This trial is currently recruiting. It is a NA study. The enrollment target is 26 participants. The study started on 2026-03-20. Estimated completion is 2031-06.
What conditions does trial NCT07419490 study?
This clinical trial studies the following conditions: Colorectal (Colon or Rectal) Cancer, Pelvic Malignancies, Oncofertility.
What interventions are being tested in trial NCT07419490?
The interventions under investigation include: Uteroovarian transposition (PROCEDURE).
Who is sponsoring clinical trial NCT07419490?
This trial is sponsored by University of South Florida, which has 252 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07419490 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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