NCT07523152

Brief 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. 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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
18mo left

Started Apr 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress6%
Apr 2026Oct 2027

Study Start

First participant enrolled

April 2, 2026

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

April 4, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 13, 2026

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2027

Last Updated

April 13, 2026

Status Verified

March 1, 2026

Enrollment Period

1.6 years

First QC Date

April 4, 2026

Last Update Submit

April 4, 2026

Conditions

Pelvic CancerAnal CancerVaginal Cancer

Keywords

vaginal canceruterus canceranal canal cancer

Outcome Measures

Primary Outcomes (1)

  • 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

    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

    at baseline, 3 months and 6 months after the end of all cancer treatment

  • Describe the progression of psychological distress

    at inclusion, at 3 months, at 6 months

Study Arms (1)

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)

Other: Assessment of sexual quality of life

Interventions

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

SINGLE-ARM INTERVENTIONAL STUDY

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsperson with cancer of the cervix, anal canal, vagina or vulva.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 given verbal consent.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pelvic NeoplasmsAnus NeoplasmsVaginal NeoplasmsUterine NeoplasmsAnal Canal Carcinoma

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsRectal NeoplasmsColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesAnus DiseasesRectal DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsVaginal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesUterine Diseases

Study Officials

  • MOUSSION AURORE

    DRCI ICM

    STUDY DIRECTOR

Central Study Contacts

LEMANSKI Claire, study principal investigator

CONTACT

04 67 61 23 91claire.lemanski@icm.unicancer.fr

MORINEAU Louison, intern medecin

CONTACT

07 86 26 63 58louison.morineau@laposte.net

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Masking Description
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Model Description
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2026

First Posted

April 13, 2026

Study Start

April 2, 2026

Primary Completion (Estimated)

October 31, 2027

Study Completion (Estimated)

October 31, 2027

Last Updated

April 13, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share