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

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ClinicalTrials.gov Identifier: NCT01650987
Recruitment Status : Completed
First Posted : July 26, 2012
Last Update Posted : August 8, 2016
Sponsor:
Information provided by (Responsible Party):
Centre Oscar Lambret

Study Description
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Brief Summary:
Evaluate the toxicities of cervix and corpus uteri carcinomas treatment

Condition or disease
Corpus Uteri Carcinoma

Detailed Description:
Evaluate the toxicities of cervix and corpus uteri carcinomas treatment on sexual function after treatment (radiotherapy and/or surgery)
Study Design
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Study Type : Observational
Actual Enrollment : 72 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Observational Study of Toxicities of Cervix and Corpus Uteri Carcinomas Treatment and Evaluation of Impact on Sexual Function
Study Start Date : May 2009
Actual Primary Completion Date : May 2015
Actual Study Completion Date : December 2015
Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. Toxicities including on sexual function [ Time Frame: up to 3 years ]
    According to Lent-Soma, NCICTC-AE v3.0, Franco-Italian Glossary


Secondary Outcome Measures :
  1. Compare the various scales of toxicity [ Time Frame: up to 3 years ]
    Compare the various scales of toxicity

  2. Study the sexual behavior modifications [ Time Frame: up to 3 years ]
    According to a questionnaire and a personal discussion

  3. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women with a corpus uteri carcinoma, without metastasis.
Criteria
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01650987


Locations
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France
Centre Oscar Lambret
Lille, France, 59020
Sponsors and Collaborators
Centre Oscar Lambret
Investigators
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Study Director: Philippe NICKERS, MD Oscar Lambret Center
More Information
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Responsible Party: Centre Oscar Lambret
ClinicalTrials.gov Identifier: NCT01650987    
Other Study ID Numbers: SEXUTOX
First Posted: July 26, 2012    Key Record Dates
Last Update Posted: August 8, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Centre Oscar Lambret:
carcinoma
uterus
Not metastatic
Additional relevant MeSH terms:
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Carcinoma
Uterine Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
 Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases