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Pelvic Exam Tool for Gynecologic Cancer Survivors

N/A

Recruiting

Led By Tyler McKinnish, M.D.

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up prior to starting treatment, at treatment mid-point (3 weeks after treatment), at end of treatment (after 6 weeks of treatment), and at 6 month follow-up visit after end of treatment

Awards & highlights

Study Summary

This trial tests a new exam-based tool to identify areas of injury from pelvic radiation & could lead to preventive strategies & exclusion of pain-causing areas from radiation fields.

Who is the study for?

This trial is for adult English-speaking women undergoing primary treatment for advanced cervical cancer with specific chemotherapy and radiation intended to cure. They must be willing to consent to the study's procedures.Check my eligibility

What is being tested?

The study aims to create a standard method for assessing pelvic floor health in patients receiving pelvic radiation, using an exam-based tool and MRI planning, which may help avoid radiating sensitive areas.See study design

What are the potential side effects?

While not explicitly listed, potential side effects could include discomfort during the pelvic exam and exposure risks associated with additional MRIs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ prior to starting treatment, at treatment mid-point (3 weeks after treatment), at end of treatment (after 6 weeks of treatment), and at 6 month follow-up visit after end of treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~prior to starting treatment, at treatment mid-point (3 weeks after treatment), at end of treatment (after 6 weeks of treatment), and at 6 month follow-up visit after end of treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and prior to starting treatment, at treatment mid-point (3 weeks after treatment), at end of treatment (after 6 weeks of treatment), and at 6 month follow-up visit after end of treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Comparison of patient-reported symptoms as measured by EORTC QLQ-CX2 compared to findings of single digit pelvic exam

Comparison of patient-reported symptoms as measured by PFDI-20 compared to findings of single digit pelvic exam

Comparison of patient-reported symptoms as measured by PFIQ-7 compared to findings of single digit pelvic exam

Secondary outcome measures

Correlate radiation dose to pelvic floor structures with symptom severity by questionnaire (EORTC QLQ-CX2, PFDI-20, and PFIQ-7) and physical exam

Determine structure level radiation dose to complex functional pelvic structures

Frequency of pelvic floor muscle dysfunction symptoms in split-field IMRT patients compared to historical controls

+4 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Single-digit pelvic examExperimental Treatment1 Intervention

Patients will have a pelvic floor muscle exam performed by their gynecologic radiation oncologist prior to treatment, at treatment mid-point (after 3 weeks of treatment), at the end of treatment (after 6 weeks of treatment), and at a follow-up visit 6 months after the end of treatment. Patients will also complete the Pelvic Floor Impact Questionnaire 7 (PFIQ-7), Pelvic Floor Disability Index (PFDI-20), and the EORTC QLQ-CX24 at these time points. The patient will also undergo a standard of care MRI prior to starting treatment.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Washington University School of MedicineLead Sponsor

1,937 Previous Clinical Trials

2,299,714 Total Patients Enrolled

1 Trials studying Gynecologic Cancers

150 Patients Enrolled for Gynecologic Cancers

Tyler McKinnish, M.D.Principal InvestigatorWashington University School of Medicine

Media Library

Single-digit pelvic exam Clinical Trial Eligibility Overview. Trial Name: NCT05769062 — N/A

Gynecologic Cancers Research Study Groups: Single-digit pelvic exam

Gynecologic Cancers Clinical Trial 2023: Single-digit pelvic exam Highlights & Side Effects. Trial Name: NCT05769062 — N/A

Single-digit pelvic exam 2023 Treatment Timeline for Medical Study. Trial Name: NCT05769062 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still vacancies available for participants in this venture?

"Per the information on clinicaltrials.gov, this research is not presently seeking applicants. It was initially posted April 30th of 2023 with its most recent update on March 13th of that same year. Although this particular trial has reached capacity in regards to participants, there are currently 71 other studies open for enrollment."

Answered by AI

What findings is this research attempting to establish?

"This medical study will track patient-reported symptoms using the PFDI-20 tool. Secondary objectives include charting the time course of pelvic floor dysfunction evolution over treatment for cervical cancer, determining the frequency of pelvic floor muscle dysfunction in split-field IMRT patients compared to historical controls, and analysing questionnaire results with thresholds described in primary outcome measurements."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Identification and Prevention of Pelvic Floor Dysfunction in Gynecologic Cancer Survivors

2023. "Identification and Prevention of Pelvic Floor Dysfunction in Gynecologic Cancer Survivors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05769062.

All > Cervical Cancer