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Completed

NCT Number: NCT02407535

Assessing Uterine Ultrasound Done as a Diagnostic Tool for the Depth of Carcinoma Invasion

In this study the investigators aim to assess the diagnostic performance of intraoperative, ultrasonographic assessment of the surgical extracted uterus for determining myometrial invasion's depth in comparison to preoperative ultrasound, intraoperative gross inspection and final pathological report (gold standard). The investigators hope that intraoperative gross inspection of the extracted uterus might offer an additional intraoperative tool for assessing the need for pelvic lymphadenectomy in early stage of endometrial cancer at least as good as pathological exam.

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Key information

Conditions

Endometrial Endometroid Carcinoma

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Carmel Medical Center

Haifa, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient's age is 18 or above
  • Patient has been scheduled to undergo hysterectomy (laparoscopic or abdominal) for the staging and treatment of endometrial cancer (endometrioid subtype) and with the relevant suspected symptoms.
  • Patient able to understand,read and sign informed consent.
  • Patient is not participating in other medical trials at present or in the past 30 days

Exclusion criteria

  • Age under 18 years
  • Patients assessed preoperatively to be at stage 2 and higher endometrial carcinoma
  • Subjects which their biopsy in the pre operating process will include high risk cell types:
  • Grade 3 endometrioid adenocarcinoma,
  • clear cell carcinoma
  • papillary serous carcinoma
  • carcinosarcoma

Treatment and study plan

Intraoperative ultrasound

Device

Diagnostic intraoperative ultrasound in the uterus after hysterectomy for assessing depth of tumor invasion

Primary outcomes

  1. Tumor invasion

    Time frame: Average of 2 weeks (immediate assessment by ultrasound, average of 2 weeks for final pathological report)

    Tumor invasion (in millimeters and in percentage of myometrial size) as assessed by ultrasound in comparison to macroscopic assesment during surgery and to final pathological report)

Sponsors and collaborators

Lead sponsor

Carmel Medical Center

Other

Registry information

Official study title

Assessing the Ultrasound Done on a the Uterus After Hysterectomy as a Diagnostic Tool for the Depth of Endometrial Carcinoma Invasion Into the Myometrium

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Apr 3, 2015
Registry last updated
Jul 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.