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NCT Number: NCT00987051

Sentinel Node and Endometrial Cancer

The purpose of this study is to investigate the relevance of sentinel node in endometrial cancer. Sentinel node is thought to reflect the status of lymph node. Only 10 to 20% of women with endometrial cancer exhibit lymph node metastasis hence systematic lymphadenectomy is questionable. In breast cancer, melanoma and vulvar cancer, sentinel node has emerged as an alternative to complete lymphadenectomy.

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Key information

Conditions

Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Tenon Hospital

Paris, 75020, France

About this study

To investigate the relevance of sentinel node in endometrial cancer. Sentinel node is though to reflect the status of lymph node. Only 10 to 20% of women with endometrial cancer exhibit lymph node metastasis hence systematic lymphadenectomy is questionable. In breast cancer, melanoma and vulvar cancer, sentinel node has emerged as an alternative to complete lymphadenectomy. The objective of our trial is to validate the concept of sentinel node in endometrial cancer.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patient over 18 years old with a surgery planned for endometrial cancer
  • endometrial cancer proved by biopsy
  • early stage of endometrial cancer (FIGO stage 1-2)
  • without contraindication to surgery
  • inform consent signed
  • affiliated to general health system

Exclusion criteria

  • endometrial cancer FIGO stages 3-4
  • previous history of surgery modifying lymphatic drainage (conization myomectomy)
  • pregnant women or breast feeding

Treatment and study plan

Detection of sentinel node

Procedure

Coelioscopy or laparotomy (based on the tumor size) after a colorimetric tracer injection

Primary outcomes

  1. Detection and false negative rates of sentinel node

    Time frame: During the surgery (hysterectomy)

Secondary outcomes

  1. Morbidity and recurrence rates

    Time frame: During 24 months

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Validation of the Sentinel Node in Endometrial Cancer

Acronym: Senti-Endo

Important dates

Study start
2007
Primary completion
2009
Study completion
2011
First posted
Sep 30, 2009
Registry last updated
Dec 11, 2012

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.

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