Toxicities of Cervix and Corpus Uteri Carcinomas Treatment and Evaluation of Impact on Sexual Function (SEXUTOX)

August 5, 2016 updated by: Centre Oscar Lambret

Prospective Observational Study of Toxicities of Cervix and Corpus Uteri Carcinomas Treatment and Evaluation of Impact on Sexual Function

Evaluate the toxicities of cervix and corpus uteri carcinomas treatment

Study Overview

Status

Completed

Conditions

Detailed Description

Evaluate the toxicities of cervix and corpus uteri carcinomas treatment on sexual function after treatment (radiotherapy and/or surgery)

Study Type

Observational

Enrollment (Actual)

72

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
      • Lille, France, 59020
        • Centre Oscar Lambret

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

Women with a corpus uteri carcinoma, without metastasis.

Description

  • Inclusion Criteria:
  • Patients whose treatment is provided to Centre Oscar Lambret
  • With a corpus uteri adenocarcinoma, no metastatic, treated by:
  • Surgery and observation without complementary treatment
  • Or surgery and adjuvant radiotherapy
  • Or Surgery and curietherapy of vaginal dome
  • With a cervix carcinoma, stade IA2 to IIB proximal, treated by :
  • External radiochemotherapy and curietherapy
  • Or only surgery
  • Or pre-surgical curietherapy and surgery
  • Age > 18 years

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
Col 1
Patient with uterus adenocarcinoma, treated by surgery, then surveillance without complementary treatment
Col 2
Patient with uterus adenocarcinoma, treated by surgery then adjuvant radiotherapy
Col 3
patient with uterus adenocarcinoma, treated by surgery then curietherapy of vaginal dome
Endometrial 4
patient with cervix carcinoma stage IA2 to IIB, treated by surgery only
endometrial 5
patient with cervix carcinoma stage IA2 to IIB, treated by surgery then curietherapy
endometrial 6
patient with cervix carcinoma stage IA2 to IIB, treated by surgery then curietherapy and radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Toxicities including on sexual function
Time Frame: up to 3 years
According to Lent-Soma, NCICTC-AE v3.0, Franco-Italian Glossary
up to 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare the various scales of toxicity
Time Frame: up to 3 years
Compare the various scales of toxicity
up to 3 years
Study the sexual behavior modifications
Time Frame: up to 3 years
According to a questionnaire and a personal discussion
up to 3 years
Specify correlation modifications of sexual behavior
Time Frame: up to 3 years
Specify the existence of a correlation between toxicities included modifications and sexual behavior modifications
up to 3 years

Collaborators and Investigators

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

Sponsor

Centre Oscar Lambret

Investigators

  • Study Director: Philippe NICKERS, MD, Oscar Lambret Center

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

May 1, 2009

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

July 20, 2012

First Submitted That Met QC Criteria

July 24, 2012

First Posted (Estimate)

July 26, 2012

Study Record Updates

Last Update Posted (Estimate)

August 8, 2016

Last Update Submitted That Met QC Criteria

August 5, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SEXUTOX

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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