Para Aortic Lymphadenectomy : Always ? (PALA)

July 28, 2020 updated by: University Hospital, Montpellier

Assesment of Paraaortic Lymphadenectomy in Locally Advanced Cervical Cancer, When no Pathologic Pelvic Lymph Node on PET/CT: Retrospective Study.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

160

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34295
        • Uhmontpellier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Patients with locally advanced cervical cancer, who had undergone a PAL after a negative paraaortic PET CT, between January 2015 and december 2019

Description

Inclusion criteria:

- Patients with :

  • locally advanced cervical cancer,
  • who undergone PAL
  • with pre operative PET CT, between January 2015 and december 2019

Exclusion criteria:

- patients aged under 18

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with locally advanced cervical cancer
Patients with locally advanced cervical cancer, who had undergone a PAL
Procedure: Para Aortic Lymphadenectomy (PAL) by laparoscopy
Para Aortic Lymphadenectomy (PAL) by laparoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
negative predictive value of PET/CT on para aortic nodes when no pathological pelvic nodes.
Time Frame: 1 day

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
morbidity of PAL
Time Frame: 1 day
morbidity of PAL
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

May 29, 2020

Study Completion (Actual)

June 30, 2020

Study Registration Dates

First Submitted

May 13, 2020

First Submitted That Met QC Criteria

May 13, 2020

First Posted (Actual)

May 19, 2020

Study Record Updates

Last Update Posted (Actual)

July 29, 2020

Last Update Submitted That Met QC Criteria

July 28, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RECHMPL20_0296

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

NC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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