Pelvic CancerSAPPHIRENCT07523152
Assessment of Sexual Quality of Life Following Local Treatment (Radiotherapy With or Without Surgery) in Patients With HPV-positive Pelvic Cancer: a Descriptive Longitudinal Study
A study testing Assessment of sexual quality of life in people with Pelvic Cancer and Anal Cancer, run by Institut du Cancer de Montpellier - Val d'Aurelle.
Trial summary
In patients with cancer associated with human papillomavirus (HPV), the physical effects of treatment, combined with the psychosexual impact linked to HPV status, can further impair the quality of sexual life. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Cancer, Anal Cancer, Vaginal Cancer
- What is being tested?
- Assessment of sexual quality of life
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- 2 Apr 2026to 31 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Women aged 18 or over.
- Sexually active patients, i.e. those who have been sexually active in the year prior to their cancer diagnosis.
- Patients being treated at the Montpellier Cancer Institute (ICM).
- Patient with pelvic squamous cell carcinoma (cervix, vagina, vulva or anus) and human papillomavirus (HPV+) infection
- Patient aware of her HPV status and how it is transmitted.
- Indicated for external radiotherapy
- Patient who has not received any oncological treatment prior to inclusion.
- Patient who has given verbal consent.
Who cannot join
- Patients receiving radiotherapy treatment outside the Montpellier Cancer Institute (ICM).
- Patients who are unwilling or unable to complete the study questionnaires.
- Patients under guardianship, curatorship or court protection,
- Patients for whom regular follow-up is impossible for psychological reasons,
- Patients who do not speak French.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
In patients with cancer associated with human papillomavirus (HPV), the physical effects of treatment, combined with the psychosexual impact linked to HPV status, can further impair the quality of sexual life.
However, few studies have examined the specific effect of HPV status (or knowledge of status) on the recovery/quality of sexuality following radiotherapy.
Read more
It is against this backdrop that we propose a prospective longitudinal study specifically dedicated to investigating the sexual quality of life of women with HPV-positive pelvic cancer.
This type of study will enable better quantification and description of sexual dysfunction occurring after treatment, and assessment of the impact of HPV carriage, with the future aim of guiding new prevention and management strategies.
Read the detailed description
Surgery for HPV-related pelvic cancers has a significant impact on patients' sexual quality of life.
In cervical cancer, several studies show a lasting impairment of sexual function following hysterectomy, particularly when it is radical. Long-term follow-up of patients confirms that these difficulties persist for several years after treatment and are influenced by factors such as age, hormonal status or the combination with other treatment modalities.
For vulvar and vaginal cancers, surgery frequently leads to disruptions in sexual life linked to anatomical changes and body image. A review of the literature highlights a high prevalence of dyspareunia, orgasmic disorders and reduced desire following vulvectomy, with significant psychosocial repercussions.
Finally, in anal canal cancer, abdominoperineal resection is particularly detrimental due to the anatomical and neurological sequelae it causes. Sexual quality of life is further impaired when a stoma is created, further impacting body image and self-esteem.
Reviews and studies focusing on women following cervical and other pelvic cancers show a high prevalence of sexual dysfunction (problems with desire, arousal, lubrication, pain, and reduced satisfaction).
Knowing that the cancer being treated is linked to a sexually transmitted HPV infection can lead to anxiety, guilt, relationship difficulties and a negative perception of sexuality, as highlighted in several recent studies. This immediate anxiety following the diagnosis is accompanied by impaired sexual function, particularly in cases involving genotypes 16 and 18, which carry the highest risk of cancer.
However, in the long term, cross-sectional studies report more nuanced findings.
In qualitative terms, the experience often revolves around the fear of transmitting the infection, the stigma associated with STIs and difficulties in communication within the couple, but may also foster greater openness in the relationship.
In patients with HPV-associated cancer, the physical effects of treatment, combined with the psychosexual impact linked to HPV status, can exacerbate the deterioration in sexual quality of life.
Several validated tools exist for assessing sexual quality of life following radiotherapy:
- FSFI (Female Sexual Function Index) - a multidimensional measure (desire, arousal, lubrication, orgasm, satisfaction, pain), widely used among cancer survivors.
- EORTC QLQ-SH22 (SHQ-C22) questionnaire - assesses the physical, psychological and social aspects of sexual life, also validated in oncology.
- Many studies describe changes in sexual function following radiotherapy, but few isolate the impact of HPV status or specifically assess HPV-positive patients.
- Methodological variability limits generalisability and prevents an accurate estimation of the incidence and progression of sexual dysfunction following treatment in the HPV-positive subpopulation.
- Although the consequences of radiotherapy with or without pelvic surgery on patients' sexual quality of life are better understood in clinical practice, the exact prevalence and temporal progression, as well as the specific impact of HPV status, remain insufficiently described.
- Conditions
- Pelvic Cancer, Anal Cancer, Vaginal Cancer
- Being tested
- Assessment of sexual quality of life
- Keywords
- vaginal cancer, uterus cancer, anal canal cancer
- Medical subject headings
- Pelvic Neoplasms, Anus Neoplasms, Vaginal Neoplasms, Uterine Neoplasms, Anal Canal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of sexual quality of lifeOther
The following questionnaires will be completed : EORTC QLQ-SH22 questionnaire, Questionnaire on the impact of HPV infection, HADS questionnaire
| Study group | Role | What they receive |
|---|---|---|
| SINGLE-ARM INTERVENTIONAL STUDY | Experimental | Patients will be seen by the investigator at the radiotherapy clinic on enrolment, at 3 months and at 6 months (the 6-month visit will mark the end of the study) Receives: Other: Assessment of sexual quality of life |
What is being measured
The primary outcome is the main question the study is designed to answer.
To describe the quality of sexual life among patients treated (radiotherapy, with or without chemotherapy, and/or surgery) as part of the management of HPV-positive pelvic cancer.
Sexual quality of life scores obtained from the European EORTC QLQ-SH22 questionnaire
Measured: at baseline, 3 months and 6 months after the end of all cancer treatment
Secondary outcomes (2)
To assess perceptions of, and the impact on sexuality of, the sexually transmitted nature (STI) of these cancers
Questionnaire on the impact of HPV infection
Measured: at baseline, 3 months and 6 months after the end of all cancer treatment
Describe the progression of psychological distress
Psychological distress scores obtained using the HADS scale, including scores for depression and anxiety.
Measured: at inclusion, at 3 months, at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start2 Apr 2026 (estimated)
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Model Description
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- MOUSSION AURORE, Study director, DRCI ICM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07523152
- Sponsor's protocol ID
- PROICM 2025-06 OSA
- Other IDs
- IDRCB
- Acronym
- SAPPHIRE
- Status last verified
- Mar 2026
- First submitted
- 4 Apr 2026
- Last updated
- 13 Apr 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 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Sexual Quality of Life Following Local Treatment (Radiotherapy With or Without Surgery) in Patients With HPV-positive Pelvic Cancer: a Descriptive Longitudinal Study
- ClinicalTrials.gov ID
- NCT07523152
- Acronym / sponsor ID
- SAPPHIRE / PROICM 2025-06 OSA
- Conditions
- Pelvic Cancer, Anal Cancer, Vaginal Cancer
- Keywords
- vaginal cancer, uterus cancer, anal canal cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Institut du Cancer de Montpellier - Val d'AurelleUniversity, hospital or other
- Study start
- 2 Apr 2026 (estimated)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 13 Apr 2026 (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.
In patients with cancer associated with human papillomavirus (HPV), the physical effects of treatment, combined with the psychosexual impact linked to HPV status, can further impair the quality of sexual life.
However, few studies have examined the specific effect of HPV status (or knowledge of status) on the recovery/quality of sexuality following radiotherapy.
It is against this backdrop that we propose a prospective longitudinal study specifically dedicated to investigating the sexual quality of life of women with HPV-positive pelvic cancer.
This type of study will enable better quantification and description of sexual dysfunction occurring after treatment, and assessment of the impact of HPV carriage, with the future aim of guiding new prevention and management strategies.
Detailed description
Surgery for HPV-related pelvic cancers has a significant impact on patients' sexual quality of life.
In cervical cancer, several studies show a lasting impairment of sexual function following hysterectomy, particularly when it is radical. Long-term follow-up of patients confirms that these difficulties persist for several years after treatment and are influenced by factors such as age, hormonal status or the combination with other treatment modalities.
For vulvar and vaginal cancers, surgery frequently leads to disruptions in sexual life linked to anatomical changes and body image. A review of the literature highlights a high prevalence of dyspareunia, orgasmic disorders and reduced desire following vulvectomy, with significant psychosocial repercussions.
Finally, in anal canal cancer, abdominoperineal resection is particularly detrimental due to the anatomical and neurological sequelae it causes. Sexual quality of life is further impaired when a stoma is created, further impacting body image and self-esteem.
Reviews and studies focusing on women following cervical and other pelvic cancers show a high prevalence of sexual dysfunction (problems with desire, arousal, lubrication, pain, and reduced satisfaction).
Knowing that the cancer being treated is linked to a sexually transmitted HPV infection can lead to anxiety, guilt, relationship difficulties and a negative perception of sexuality, as highlighted in several recent studies. This immediate anxiety following the diagnosis is accompanied by impaired sexual function, particularly in cases involving genotypes 16 and 18, which carry the highest risk of cancer.
However, in the long term, cross-sectional studies report more nuanced findings.
In qualitative terms, the experience often revolves around the fear of transmitting the infection, the stigma associated with STIs and difficulties in communication within the couple, but may also foster greater openness in the relationship.
In patients with HPV-associated cancer, the physical effects of treatment, combined with the psychosexual impact linked to HPV status, can exacerbate the deterioration in sexual quality of life.
Several validated tools exist for assessing sexual quality of life following radiotherapy:
- FSFI (Female Sexual Function Index) - a multidimensional measure (desire, arousal, lubrication, orgasm, satisfaction, pain), widely used among cancer survivors.
- EORTC QLQ-SH22 (SHQ-C22) questionnaire - assesses the physical, psychological and social aspects of sexual life, also validated in oncology.
- Many studies describe changes in sexual function following radiotherapy, but few isolate the impact of HPV status or specifically assess HPV-positive patients.
- Methodological variability limits generalisability and prevents an accurate estimation of the incidence and progression of sexual dysfunction following treatment in the HPV-positive subpopulation.
- Although the consequences of radiotherapy with or without pelvic surgery on patients' sexual quality of life are better understood in clinical practice, the exact prevalence and temporal progression, as well as the specific impact of HPV status, remain insufficiently described.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Model Description
| Arm | Type | Receives |
|---|---|---|
| SINGLE-ARM INTERVENTIONAL STUDY | Experimental | Other: Assessment of sexual quality of lifePatients will be seen by the investigator at the radiotherapy clinic on enrolment, at 3 months and at 6 months (the 6-month visit will mark the end of the study) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Women aged 18 or over.
- Sexually active patients, i.e. those who have been sexually active in the year prior to their cancer diagnosis.
- Patients being treated at the Montpellier Cancer Institute (ICM).
- Patient with pelvic squamous cell carcinoma (cervix, vagina, vulva or anus) and human papillomavirus (HPV+) infection
- Patient aware of her HPV status and how it is transmitted.
Key exclusion criteria (5 listed)
- Patients receiving radiotherapy treatment outside the Montpellier Cancer Institute (ICM).
- Patients who are unwilling or unable to complete the study questionnaires.
- Patients under guardianship, curatorship or court protection,
- Patients for whom regular follow-up is impossible for psychological reasons,
- Patients who do not speak French.
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 |
|---|---|---|
| Assessment of sexual quality of lifeThe following questionnaires will be completed : EORTC QLQ-SH22 questionnaire, Questionnaire on the impact of HPV infection, HADS questionnaire | Other | SINGLE-ARM INTERVENTIONAL STUDY |
Primary outcome
To describe the quality of sexual life among patients treated (radiotherapy, with or without chemotherapy, and/or surgery) as part of the management of HPV-positive pelvic cancer.
Time frame: at baseline, 3 months and 6 months after the end of all cancer treatment
Sexual quality of life scores obtained from the European EORTC QLQ-SH22 questionnaire
2 secondary outcomes
To assess perceptions of, and the impact on sexuality of, the sexually transmitted nature (STI) of these cancers
Time frame: at baseline, 3 months and 6 months after the end of all cancer treatment
Describe the progression of psychological distress
Time frame: at inclusion, at 3 months, at 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 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.
MOUSSION AURORE study director
DRCI ICM
Questions about this trial
What is this clinical trial studying?
A study testing Assessment of sexual quality of life in people with Pelvic Cancer and Anal Cancer, run by Institut du Cancer de Montpellier - Val d'Aurelle.
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 8 inclusion and 5 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: opening soon, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact LEMANSKI Claire, study principal investigator (04 67 61 23 91, claire.lemanski@icm.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To describe the quality of sexual life among patients treated (radiotherapy, with or without chemotherapy, and/or surgery) as part of the management of HPV-positive pelvic cancer. (time frame: at baseline, 3 months and 6 months after the end of all cancer treatment). 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 13 Apr 2026.