Corpus Uteri CarcinomaSEXUTOXNCT01650987
Toxicities of Cervix and Corpus Uteri Carcinomas Treatment and Evaluation of Impact on Sexual Function
An observational study of Corpus Uteri Carcinoma, run by Centre Oscar Lambret at 1 site in France.
Trial summary
Evaluate the toxicities of cervix and corpus uteri carcinomas treatment Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Corpus Uteri Carcinoma
- How many people
- 72 participants
- Where
- 1 siteFrance
- Study dates
- May 2009to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women with a corpus uteri carcinoma, without metastasis.
Who may be able to join
- 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 :
Show all 10Show fewer
- External radiochemotherapy and curietherapy
- Or only surgery
- Or pre-surgical curietherapy and surgery
- Age > 18 years
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the detailed description
Evaluate the toxicities of cervix and corpus uteri carcinomas treatment on sexual function after treatment (radiotherapy and/or surgery)
- Conditions
- Corpus Uteri Carcinoma
- Keywords
- carcinoma, uterus, Not metastatic
- Medical subject headings
- Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Toxicities including on sexual function
According to Lent-Soma, NCICTC-AE v3.0, Franco-Italian Glossary
Measured: up to 3 years
Secondary outcomes (3)
Compare the various scales of toxicity
Compare the various scales of toxicity
Measured: up to 3 years
Study the sexual behavior modifications
According to a questionnaire and a personal discussion
Measured: up to 3 years
Specify correlation modifications of sexual behavior
Specify the existence of a correlation between toxicities included modifications and sexual behavior modifications
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2012 (estimated)
- Study startMay 2009
- Primary completionMay 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corpus Uteri CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Oscar Lambret
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe NICKERS, MD, Study director, Oscar Lambret Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01650987
- Sponsor's protocol ID
- SEXUTOX
- Acronym
- SEXUTOX
- Status last verified
- Aug 2016
- First submitted
- 20 Jul 2012
- Last updated
- 8 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study of Toxicities of Cervix and Corpus Uteri Carcinomas Treatment and Evaluation of Impact on Sexual Function
- ClinicalTrials.gov ID
- NCT01650987
- Acronym / sponsor ID
- SEXUTOX / SEXUTOX
- Conditions
- Corpus Uteri Carcinoma
- Keywords
- carcinoma, uterus, Not metastatic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Centre Oscar LambretUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- May 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 26 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the toxicities of cervix and corpus uteri carcinomas treatment
Detailed description
Evaluate the toxicities of cervix and corpus uteri carcinomas treatment on sexual function after treatment (radiotherapy and/or surgery)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with a corpus uteri carcinoma, without metastasis.
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Toxicities including on sexual function
Time frame: up to 3 years
According to Lent-Soma, NCICTC-AE v3.0, Franco-Italian Glossary
3 secondary outcomes
Compare the various scales of toxicity
Time frame: up to 3 years
Study the sexual behavior modifications
Time frame: up to 3 years
Specify correlation modifications of sexual behavior
Time frame: up to 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe NICKERS, MD study director
Oscar Lambret Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Corpus Uteri Carcinoma, run by Centre Oscar Lambret at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Toxicities including on sexual function (time frame: up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2016.