Validation of the Sentinel Node in Endometrial Cancer
18 Years
N/A
Female
Endometrial Neoplasms
Trial Information
Validation of the Sentinel Node in Endometrial Cancer
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.
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
Detection and false negative rates of sentinel node
Outcome Time Frame:
During the surgery (hysterectomy)
Safety Issue:
No
Principal Investigator
Emile DARAÏ, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Assistance Publique - Hôpitaux de Paris
Authority:
France: Ministry of Health
Study ID:
P060229
NCT ID:
NCT00987051
Start Date:
April 2007
Completion Date:
October 2011
Related Keywords:
- Endometrial Neoplasms
- sentinel node procedure
- radiocolloid
- patent blue
- Neoplasms
- Endometrial Neoplasms
- Adenoma
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