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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2012 by Centre Oscar Lambret
Sponsor:
Information provided by (Responsible Party):
Centre Oscar Lambret
ClinicalTrials.gov Identifier:
NCT01650987
First received: July 20, 2012
Last updated: July 26, 2012
Last verified: July 2012
  Purpose

Evaluate the toxicities of cervix and corpus uteri carcinomas treatment


Condition
Corpus Uteri Carcinoma

Study Type: Observational
Study Design: 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

Further study details as provided by Centre Oscar Lambret:

Primary Outcome Measures:
  • Toxicities including on sexual function [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
    According to Lent-Soma, NCICTC-AE v3.0, Franco-Italian Glossary


Secondary Outcome Measures:
  • Compare the various scales of toxicity [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
    Compare the various scales of toxicity

  • Study the sexual behavior modifications [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
    According to a questionnaire and a personal discussion

  • Specify correlation modifications of sexual behavior [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
    Specify the existence of a correlation between toxicities included modifications and sexual behavior modifications


Estimated Enrollment: 180
Study Start Date: May 2009
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01650987

Contacts
Contact: Philippe NICKERS, PhD p-nickers@o-lambret.fr
Contact: VENDEL Yvette, CRA sponsor 03 20 29 59 40 y-vendel@o-lambret.fr

Locations
France
Centre Oscar Lambret Recruiting
Lille, France, 59020
Contact: Philippe NICKERS, PhD       p-nickers@o-lambret.fr   
Sub-Investigator: Eric LARTIGAU, PhD         
Sub-Investigator: Bernard CASTELAIN, MD         
Sub-Investigator: Eric LEBLANC, MD         
Sub-Investigator: Fabrice NARDUCCI, MD         
Sub-Investigator: Anne LESOIN, MD         
Sub-Investigator: Annick CHEVALIER-PLACE, MD         
Sponsors and Collaborators
Centre Oscar Lambret
Investigators
Study Director: Philippe NICKERS, MD Oscar Lambret Center
  More Information

No publications provided

Responsible Party: Centre Oscar Lambret
ClinicalTrials.gov Identifier: NCT01650987     History of Changes
Other Study ID Numbers: SEXUTOX
Study First Received: July 20, 2012
Last Updated: July 26, 2012
Health Authority: France: The Commission nationale de l’informatique et des libertés

Keywords provided by Centre Oscar Lambret:
carcinoma
uterus
Not metastatic

Additional relevant MeSH terms:
Carcinoma
Uterine Neoplasms
Genital Diseases, Female
Genital Neoplasms, Female
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Uterine Diseases

ClinicalTrials.gov processed this record on November 24, 2014