Para Aortic Lymphadenectomy : Always ?
PALA
Assesment of Paraaortic Lymphadenectomy in Locally Advanced Cervical Cancer, When no Pathologic Pelvic Lymph Node on PET/CT: Retrospective Study.
1 other identifier
observational
160
1 country
1
Brief Summary
Cervical cancer affects more than 3000 new cases per year in France. The treatment of stage IB3 to IVA cervical cancer is based on concomitant radio-chemotherapy. The irradiation volumes are based, according to current recommendations, on imaging examinations and / or on the results of a laparoscopic Para-aortic lymphadenectomy (PAL). There is some risk of false negatif with the PET/CT. For this reason, most of the time, PAL is offered when there is no pathological paraaortic lymph node on PET/CT. The investigators suppose that this staging surgery could be avoid when no pathological pelvic nodes are identified on PET/CT. The investigators use a retrospective study, to analyse histological report of systematic PAL, comparing to results of pre-operative PET/CT.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2017
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2017
CompletedFirst Submitted
Initial submission to the registry
May 13, 2020
CompletedFirst Posted
Study publicly available on registry
May 19, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 29, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2020
CompletedJuly 29, 2020
July 1, 2020
3.4 years
May 13, 2020
July 28, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
negative predictive value of PET/CT on para aortic nodes when no pathological pelvic nodes.
negative predictive value of PET/CT on para aortic nodes when no pathological pelvic nodes. The intraoperative 3D optical scan gives the tumor localization obtained by radioguided occult lesion localization thanks to pen marking left by the surgeon. The comparison is done by superimposing both acquisitions.
1 day
Secondary Outcomes (1)
morbidity of PAL
1 day
Study Arms (1)
Patients with locally advanced cervical cancer
Patients with locally advanced cervical cancer, who had undergone a PAL
Interventions
Para Aortic Lymphadenectomy (PAL) by laparoscopy
Eligibility Criteria
Patients with locally advanced cervical cancer, who had undergone a PAL after a negative paraaortic PET CT, between January 2015 and december 2019
You may qualify if:
- \- Patients with :
- locally advanced cervical cancer,
- who undergone PAL
- with pre operative PET CT, between January 2015 and december 2019
You may not qualify if:
- \- patients aged under 18
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Uhmontpellier
Montpellier, 34295, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Martha DURAES, Md
University Hospital, Montpellier
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 13, 2020
First Posted
May 19, 2020
Study Start
January 1, 2017
Primary Completion
May 29, 2020
Study Completion
June 30, 2020
Last Updated
July 29, 2020
Record last verified: 2020-07