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Intrauterine Manipulation for Endometrial Cancer

N/A

Recruiting

Led By Okechukwu Ibeanu, MD

Research Sponsored by WellSpan Health

Eligibility Criteria Checklist

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

Must have

No clinical evidence of disseminated intraperitoneal disease

Planned standard of care surgical management of early stage endometrial cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial will test whether the Vcare® intrauterine manipulator increases the chance of finding cancer cells in the abdomen in women undergoing surgery for early stage endometrial cancer.

Who is the study for?

This trial is for adults over 18 with diagnosed endometrial cancer who are able to consent and are set for standard surgical treatment without signs of widespread disease in the abdomen. It's not for those whose final pathology isn't endometrial cancer, have spread of cancer within the abdomen, can't undergo surgery, or choose non-surgical management.Check my eligibility

What is being tested?

The study investigates if using a Vcare® intrauterine manipulator during surgery increases the chance of finding cancer cells in the abdominal fluid in early stage (FIGO I/II) endometrial cancer patients.See study design

What are the potential side effects?

Since this trial focuses on a surgical procedure rather than a drug, side effects may include typical risks associated with surgery such as infection, bleeding, or injury to surrounding organs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer has not spread within my abdomen.

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I am scheduled for surgery for early stage endometrial cancer.

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I have been diagnosed with endometrial cancer through a biopsy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Conversion of positive peritoneal cytology

Secondary outcome measures

Recurrence rate

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: V-care uterine manipulatorExperimental Treatment1 Intervention

Patients in the V-care uterine manipulator arm will undergo standard staging surgery utilizing a V-care uterine manipulator in the standard fashion

Group II: Sponge stickActive Control1 Intervention

Patients in the sponge stick arm will undergo standard staging surgery utilizing a non-invasive sponge stick for cervical delineation.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

surgical staging

2022

N/A

~460

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

WellSpan HealthLead Sponsor

28 Previous Clinical Trials

2,004,288 Total Patients Enrolled

1 Trials studying Endometrial Cancer

150 Patients Enrolled for Endometrial Cancer

Graham Brown, DOLead Sponsor

1 Previous Clinical Trials

276 Total Patients Enrolled

Okechukwu Ibeanu, MDPrincipal InvestigatorWellSpan Health

2 Previous Clinical Trials

426 Total Patients Enrolled

1 Trials studying Endometrial Cancer

150 Patients Enrolled for Endometrial Cancer

Media Library

surgical staging Clinical Trial Eligibility Overview. Trial Name: NCT04570553 — N/A

Endometrial Cancer Research Study Groups: Sponge stick, V-care uterine manipulator

Endometrial Cancer Clinical Trial 2023: surgical staging Highlights & Side Effects. Trial Name: NCT04570553 — N/A

surgical staging 2023 Treatment Timeline for Medical Study. Trial Name: NCT04570553 — N/A

Frequently Asked Questions

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

What is the current participant count of this research project?

"Affirmative. The details hosted on clinicaltrials.gov demonstrate that this experiment began recruitment on October 15th 2020, and has been collecting new data as recently as June 2nd 2022. 350 candidates are needed at 1 testing site for the study to be deemed successful."

Answered by AI

Are there opportunities to still participate in this research?

"Affirmative. Per the information on clinicaltrials.gov, this medical study is actively seeking participants and was initially posted on October 15th 2020. As of June 2nd 2022, 350 patients need to be enrolled from a single site for the trial to go forward."

Answered by AI

Recent research and studies

American Journal of Obstetrics and GynecologyJournal

The Prognostic Value of Peritoneal Cytology in Gynecologic Malignant Disease

Creasman, William T., and Felix Rutledge. 1971. “The Prognostic Value of Peritoneal Cytology in Gynecologic Malignant Disease”. American Journal of Obstetrics and Gynecology. Elsevier BV. doi:10.1016/0002-9378(71)90571-0.

Gynecologic OncologyJournal

Follow-up After Primary Therapy for Endometrial Cancer: A Systematic Review

Fung-Kee-Fung, Michael, Jason Dodge, Laurie Elit, Himu Lukka, Alex Chambers, and Tom Oliver. 2006. “Follow-up After Primary Therapy for Endometrial Cancer: A Systematic Review”. Gynecologic Oncology. Elsevier BV. doi:10.1016/j.ygyno.2006.02.011.

American Journal of Obstetrics and GynecologyJournal

Prognosis and Treatment of Positive Peritoneal Cytology in Early Endometrial Cancer: Matched Cohort Analyses from the National Cancer Database

Seagle, Brandon-Luke L., Amy L. Alexander, Taliya Lantsman, and Shohreh Shahabi. 2018. “Prognosis and Treatment of Positive Peritoneal Cytology in Early Endometrial Cancer: Matched Cohort Analyses from the National Cancer Database”. American Journal of Obstetrics and Gynecology. Elsevier BV. doi:10.1016/j.ajog.2017.11.601.

The LancetJournal