Anal CancerSEQUOIANCT05109468
Assessment of Patients' Quality of Sexual Life After Anal Cancer Treatment
An observational study of Anal Cancer and Sexuality, run by Institut du Cancer de Montpellier - Val d'Aurelle at 1 site in France.
Trial summary
The purpose of this this study, to evaluate the quality of sexual life of patients treated for anal cancer treated by radiotherapy, during their treatment, then 3 months after treatment and, finally, 2 years after treatment. cancer diagnosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anal Cancer, Sexuality, Psychologic Stress
- What is being tested?
- Quality of life questionnaire
- How many people
- 46 participants
- Where
- 1 siteFrance
- Study dates
- 6 Jun 2021to 6 Jan 2026
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This project is a descriptive study without formal calculation of the number of subjects required. The sample size will be based on the ability to recruit at the ICM over a 30-month period. The active queue of patients at the ICM is about 3 to 4 patients per month, with an estimate of the proportion of refusals expected at 50% in these patients still on the shock of the announcement of cancer, where the theme of sexuality does not always appear essential at this time. Recruiting 50 patients would make it possible to have an estimate (for descriptive purposes) of the mean scores after treatment (visit 3 months after treatment) on the EORTC SHQ-C22 quality of sexual life questionnaire (the range of which goes from 0 to 100 ), with a level of precision of 12.25 (amplitude of the confidence interval) for a two-sided 95% confidence interval and a standard deviation of 22.
Who may be able to join
- Age> 18 years old.
- Patient treated for non-metastatic squamous cell anus cancer with the presence of an HPV infection authenticated on the biopsy.
- Patient living with a partner or having an active sex life the year preceding the diagnosis.
- Patient who, after information, agrees to participate in the study.
- Patient affiliated to a French social security scheme.
Who cannot join
- Patient unable or unwilling to complete a questionnaire on the quality of sexual life.
- Patient without sexual activity the year before diagnosis.
- Patient whose regular follow-up is impossible for psychological, family, social or geographic reasons.
- Patient under guardianship, curatorship or legal protection.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this this study, to evaluate the quality of sexual life of patients treated for anal cancer treated by radiotherapy, during their treatment, then 3 months after treatment and, finally, 2 years after treatment. cancer diagnosis.
Read the detailed description
Sexual health is defined by WHO in 2011 as a state of physical, emotional, mental and social well-being in relation to sexuality. It is an integral part of health, well-being and quality of life and is recognized as a right of everyone.Alteration of sexuality after cancer impacts all phases of the sexual response. It is multifactorial: psychological (ie, anxiety linked to the disease, fear of death, or impairment of body image) and physiological (ie, alteration of the sexual reaction which may be linked, in part, to direct sequelae generated by irradiation of the genitals).
Anal cancer remains fairly rare, affecting around 2,200 people each year in France, with a predominance of women (60 to 70% of patients), However, its incidence has been growing strongly for 30 years, in Europe and the United States where it is has increased by 70% over the last 10 years alone, in both men and women, with an increasingly younger population.
It is linked, in more than 90% of cases, to a carcinogenic virus, the Human PapillomaVirus (HPV), a late consequence of an infection, most often asymptomatic, transmitted by the sexual route.
The question of sexuality after cancer remains, in fact, very little addressed by doctors who express a lack of training. Patients, for their part, often do not dare to raise the issue with caregivers, out of modesty, or thinking that the teams do not have the time. Discussions with patients therefore generally always remain focused on oncological management, from the initial consultation to the follow-up consultations. The hope of recovery awaited on each of the assessments and the fear of relapse often obscure more global and equally essential questions: whether it is about the quality of life, the after-effects, or even more, the quality. of sex life. For these reasons, this study will collect the information provided to patients on the impact of this treatment on their sexual health, whether it is medical information recorded in the file, or information perceived and retained by patients.
- Conditions
- Anal Cancer, Sexuality, Psychologic Stress, HPV, Anxiety
- Being tested
- Quality of life questionnaire
- Medical subject headings
- Anus Neoplasms, Sexuality, Stress, Psychological, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality of life questionnaireOther
to assess the quality of sexual life of patients treated for anal cancer treated with radiotherapy, during their treatment, then 3 months after treatment and, finally, 2 years after cancer diagnosis.
| Study group | Role | What they receive |
|---|---|---|
| Anal cancer patients | Non-metastatic squamous anus cancer with the presence of an HPV infection authenticated on the biopsy Receives: Other: Quality of life questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Sexual quality of life score
Sexual quality of life score obtained on the European EORTC SHQ-C22 questionnaire
Measured: at inclusion, 3 months post-treatment and 2 years after the announcement of cancer.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2021
- Study start6 Jun 2021
- Primary completion31 Aug 2023
- Study completion6 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anal CancerStudies of the same condition, open and under way.
- More trials run by Institut du Cancer de Montpellier - Val d'AurelleThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claire LEMANSKI, MD, Study chair, Institut Régional du Cancer de Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05109468
- Sponsor's protocol ID
- PROICM 2021-03 OSE
- Acronym
- SEQUOIA
- Status last verified
- Sep 2026
- First submitted
- 4 Oct 2021
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Patients' Quality of Sexual Life After Anal Cancer Treatment
- ClinicalTrials.gov ID
- NCT05109468
- Acronym / sponsor ID
- SEQUOIA / PROICM 2021-03 OSE
- Conditions
- Anal Cancer, Sexuality, Psychologic Stress, HPV, Anxiety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Institut du Cancer de Montpellier - Val d'AurelleUniversity, hospital or other
- Study start
- 6 Jun 2021 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 6 Jan 2026 (actual)
- First posted
- 5 Nov 2021 (actual)
- 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.
The purpose of this this study, to evaluate the quality of sexual life of patients treated for anal cancer treated by radiotherapy, during their treatment, then 3 months after treatment and, finally, 2 years after treatment. cancer diagnosis.
Detailed description
Sexual health is defined by WHO in 2011 as a state of physical, emotional, mental and social well-being in relation to sexuality. It is an integral part of health, well-being and quality of life and is recognized as a right of everyone.Alteration of sexuality after cancer impacts all phases of the sexual response. It is multifactorial: psychological (ie, anxiety linked to the disease, fear of death, or impairment of body image) and physiological (ie, alteration of the sexual reaction which may be linked, in part, to direct sequelae generated by irradiation of the genitals).
Anal cancer remains fairly rare, affecting around 2,200 people each year in France, with a predominance of women (60 to 70% of patients), However, its incidence has been growing strongly for 30 years, in Europe and the United States where it is has increased by 70% over the last 10 years alone, in both men and women, with an increasingly younger population.
It is linked, in more than 90% of cases, to a carcinogenic virus, the Human PapillomaVirus (HPV), a late consequence of an infection, most often asymptomatic, transmitted by the sexual route.
The question of sexuality after cancer remains, in fact, very little addressed by doctors who express a lack of training. Patients, for their part, often do not dare to raise the issue with caregivers, out of modesty, or thinking that the teams do not have the time. Discussions with patients therefore generally always remain focused on oncological management, from the initial consultation to the follow-up consultations. The hope of recovery awaited on each of the assessments and the fear of relapse often obscure more global and equally essential questions: whether it is about the quality of life, the after-effects, or even more, the quality. of sex life. For these reasons, this study will collect the information provided to patients on the impact of this treatment on their sexual health, whether it is medical information recorded in the file, or information perceived and retained by patients.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anal cancer patients | – | Other: Quality of life questionnaireNon-metastatic squamous anus cancer with the presence of an HPV infection authenticated on the biopsy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This project is a descriptive study without formal calculation of the number of subjects required. The sample size will be based on the ability to recruit at the ICM over a 30-month period. The active queue of patients at the ICM is about 3 to 4 patients per month, with an estimate of the proportion of refusals expected at 50% in these patients still on the shock of the announcement of cancer, where the theme of sexuality does not always appear essential at this time. Recruiting 50 patients would make it possible to have an estimate (for descriptive purposes) of the mean scores after treatment (visit 3 months after treatment) on the EORTC SHQ-C22 quality of sexual life questionnaire (the range of which goes from 0 to 100 ), with a level of precision of 12.25 (amplitude of the confidence interval) for a two-sided 95% confidence interval and a standard deviation of 22.
Key inclusion criteria (5 listed)
- Age> 18 years old.
- Patient treated for non-metastatic squamous cell anus cancer with the presence of an HPV infection authenticated on the biopsy.
- Patient living with a partner or having an active sex life the year preceding the diagnosis.
- Patient who, after information, agrees to participate in the study.
- Patient affiliated to a French social security scheme.
Key exclusion criteria (4 listed)
- Patient unable or unwilling to complete a questionnaire on the quality of sexual life.
- Patient without sexual activity the year before diagnosis.
- Patient whose regular follow-up is impossible for psychological, family, social or geographic reasons.
- Patient under guardianship, curatorship or legal protection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quality of life questionnaireto assess the quality of sexual life of patients treated for anal cancer treated with radiotherapy, during their treatment, then 3 months after treatment and, finally, 2 years after cancer diagnosis. | Other | Anal cancer patients |
Primary outcome
Change in Sexual quality of life score
Time frame: at inclusion, 3 months post-treatment and 2 years after the announcement of cancer.
Sexual quality of life score obtained on the European EORTC SHQ-C22 questionnaire
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 14 Sep 2026.
- 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.
Claire LEMANSKI, MD study chair
Institut Régional du Cancer de Montpellier
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 Anal Cancer and Sexuality, run by Institut du Cancer de Montpellier - Val d'Aurelle 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 5 inclusion and 4 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 14 Sep 2026. 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?
Change in Sexual quality of life score (time frame: at inclusion, 3 months post-treatment and 2 years after the announcement of cancer.). 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 14 Sep 2026.