ClinicalTrials.gg
CompletedNCT01650987SEXUTOXUpdated Aug 8, 2016

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

An observational study in Corpus Uteri Carcinoma, sponsored by Centre Oscar Lambret. Completed at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-08-08.

Sponsored by Centre Oscar Lambret · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
72
Ages
18 Years and older
Sex
Female
01

Study summary

Evaluate the toxicities of cervix and corpus uteri carcinomas treatment

Read the detailed description

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

02

Conditions studied

  • Corpus Uteri Carcinoma

Browse trials for

Keywords

  • carcinoma
  • uterus
  • Not metastatic
03

In context

Carcinoma

6,719 studies on the registry are indexed under Carcinoma; 1,142 are open to participants now.

This study's enrollment of 72 is below the median of 150 across 1,170 observational studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Centre Oscar Lambret is the lead sponsor of 130 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Women with a corpus uteri carcinoma, without metastasis.

Eligibility 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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
72 participants (actual)

Groups and 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

06

What researchers measure

Primary outcomes

  1. Toxicities including on sexual function

    According to Lent-Soma, NCICTC-AE v3.0, Franco-Italian Glossary

    Time frame: up to 3 years

Secondary outcomes

  1. Compare the various scales of toxicity

    Compare the various scales of toxicity

    Time frame: up to 3 years

  2. Study the sexual behavior modifications

    According to a questionnaire and a personal discussion

    Time frame: up to 3 years

  3. Specify correlation modifications of sexual behavior

    Specify the existence of a correlation between toxicities included modifications and sexual behavior modifications

    Time frame: up to 3 years

07

Study locations

1 site
  • Centre Oscar Lambret
    Lille, 59020, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of May 2009, a primary completion of May 2015 and a completion of Dec 2015. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 20, 2012
First posted
Jul 26, 2012
Start
May 2009
Primary completionActual
May 2015
CompletionActual
Dec 2015
Last update
Aug 8, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 8, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01650987
Responsible party
Sponsor
First posted
Jul 26, 2012
Start date
May 2009
Primary completion
May 2015
Completion
Dec 2015
Last update
Aug 8, 2016

Study contacts

Philippe NICKERS, MD
study director · Oscar Lambret Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion