ClinicalTrials.gg
CompletedNCT00987051Senti-EndoUpdated Dec 11, 2012

Sentinel Node and Endometrial Cancer

An interventional study of Detection of sentinel node in Endometrial Neoplasms, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-12-11.

Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
133
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Endometrial Neoplasms

Keywords

  • sentinel node procedure
  • radiocolloid
  • patent blue
03

In context

Endometrial Neoplasms

1,347 studies on the registry are indexed under Endometrial Neoplasms; 452 are open to participants now.

This study's enrollment of 133 is above the median of 70 across 954 interventional studies indexed under Endometrial Neoplasms.

Browse Endometrial Neoplasms studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,576 studies on the registry; 1,028 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • endometrial cancer FIGO stages 3-4
  • previous history of surgery modifying lymphatic drainage (conization myomectomy)
  • pregnant women or breast feeding
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
133 participants (actual)

Study arms

  • Experimental
    1

    Patients with endometrial cancer

    Procedure: Detection of sentinel node

Interventions

  • ProcedureDetection of sentinel node

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

06

What researchers measure

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

07

Study locations

1 site
  • Tenon Hospital
    Paris, 75020, France
08

References and documents

Publications

  • Darai E, Dubernard G, Bats AS, Heitz D, Mathevet P, Marret H, Querleu D, Golfier F, Leblanc E, Rouzier R, Ballester M. Sentinel node biopsy for the management of early stage endometrial cancer: long-term results of the SENTI-ENDO study. Gynecol Oncol. 2015 Jan;136(1):54-9. doi: 10.1016/j.ygyno.2014.09.011. Epub 2014 Oct 22. PubMed 25450151 ↗
  • Ballester M, Dubernard G, Lecuru F, Heitz D, Mathevet P, Marret H, Querleu D, Golfier F, Leblanc E, Rouzier R, Darai E. Detection rate and diagnostic accuracy of sentinel-node biopsy in early stage endometrial cancer: a prospective multicentre study (SENTI-ENDO). Lancet Oncol. 2011 May;12(5):469-76. doi: 10.1016/S1470-2045(11)70070-5. Epub 2011 Apr 12. PubMed 21489874 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Apr 2007, a primary completion of Dec 2009 and a completion of Oct 2011. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 30, 2009
First posted
Sep 30, 2009
Start
Apr 2007
Primary completionActual
Dec 2009
CompletionActual
Oct 2011
Last update
Dec 11, 2012
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 11, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00987051
Responsible party
Sponsor
First posted
Sep 30, 2009
Start date
Apr 2007
Primary completion
Dec 2009
Completion
Oct 2011
Last update
Dec 11, 2012

Study contacts

Emile DARAÏ, MD
principal investigator · Assistance Publique - Hôpitaux de Paris

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2012. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion