Evaluating HPV vaccination after treatment for cervical lesions

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase II interventional study focuses on women over 45 years old who are chronic HPV carriers and have been treated for high-grade cervical lesions. Participants will receive HPV vaccination to assess the rate of HPV clearance within two years following treatment. The study includes a vaccinated cohort receiving the HPV vaccine and a non-vaccinated observational cohort for comparison. Key objectives include evaluating the safety of the vaccine, the incidence of recurrence of cervical lesions, and the potential development of invasive gynecological cancers.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Common eligibility criteria for the study (for both cohorts) :

   1. Female patient over 45 years old
   2. Patient treated by conization for high-grade cervical epithelial lesion
   3. Positive HPV test at the 6-month post-operative control (a delay of 6 to 12 months will be accepted), leading to an indication for a control colposcopy (+/- biopsy) according to standard surveillance practices.
   4. N.B. : Patients with abnormalities at the initial control colposcopy and/or positive biopsy remain eligible for the study, whether vaccinated or not.
2. Additional eligibility criteria for the clinical trial (Vaccinated patients cohort)

   1. No contraindication to HPV vaccination with Gardasil 9
   2. Patient consented to HPV vaccination with Gardasil 9
   3. Affiliated with a social security system
   4. Informed and signed written consent provided
   5. N.B. : Patients infected with HIV are eligible for the vaccine trial provided they are on antiretroviral therapy.
3. Inclusion criteria for the data study (Non-vaccinated patients cohort)

   1. Patient eligible for the study (a) and not eligible for the clinical trial (b) due to:

      * refusal of vaccination, or
      * A contraindication to vaccination
   2. No objection to the use of their personal data for research purposes

N.B. : A patient who initially refused vaccination may later request to be vaccinated as part of the trial after signing the consent form. The vaccine trial analysis will include all patients who started vaccination within 6 months after the initial HPV control test.

Exclusion Criteria:

1. Common exclusion criteria for the study (for both cohorts)

   1. History of primary HPV vaccination
   2. History of HPV-induced invasive cancer (cervical, vaginal, vulvar, anal, oropharyngeal cancer)
2. Exclusion criteria for the clinical trial (Vaccinated patients cohort)

   1. Patient refusing HPV vaccination
   2. Patient with a contraindication to HPV vaccination with Gardasil 9
   3. Patient deprived of liberty or under guardianship
3. Exclusion criteria for the data study (Non-vaccinated patients cohort) a) Opposition to the use of their personal data for research purposes

Where it's running

• Centre Oscar Lambret
  Lille, France Recruiting

Study contacts

• Study coordinator: Emilie HEYMAN-DECOUPIGNY
• Email: promotion@o-lambret.fr
• Phone: 0320295918

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Moderately Hypofractionated Neoadjuvant Radiotherapy for Soft Tissue Sarcoma of the Limbs or Trunk Wall

  This trial tests whether giving a shorter course of radiotherapy before surgery helps control soft tissue sarcoma in the limbs or trunk without waiting longer.

  Recruiting Phase 2 Centre Oscar Lambret · Lille · NCT07507773

• Snoezelen multisensory relaxation to reduce anxiety during pediatric chemotherapy hospital stays

  This will try Snoezelen multisensory relaxation sessions to see if they reduce anxiety in children and adolescents aged 8–17 hospitalized for chemotherapy.

  Recruiting Centre Oscar Lambret · Lille · NCT07202507

• Clinical and biological database for people with advanced ovarian, peritoneal, or fallopian tube cancer

  This project will collect clinical information, blood and tumor samples, and regular quality-of-life questionnaires from people newly diagnosed with advanced ovarian, peritoneal, or fallopian tube cancer to see if combining patient and tumor features can predict overall survival.

  Recruiting Centre Oscar Lambret · Lille · NCT06969833

• Vaginal radiofrequency for vulvovaginal atrophy in people with breast cancer

  This will see if adding three sessions of vaginal radiofrequency to regular hyaluronic acid moisturizer reduces vaginal dryness in women taking aromatase inhibitors for breast cancer.

  Recruiting Centre Oscar Lambret · Lille · NCT06900374

• Evaluating a digital care plan for patients with advanced sarcomas on second-line treatment

  This study is testing if a new digital care plan can help people with advanced sarcomas on second-line treatment have fewer severe side effects compared to the usual care they receive.

  Recruiting at 7 sites Centre Oscar Lambret · Lyon, Auvergne-Rhône-Alpes and 10 other locations · NCT06211257

• Comparing in-person and remote monitoring for cancer follow-up

  This study is testing whether patients with rare tumors follow their post-treatment care plans better with in-person visits from a doctor or remote check-ins with a nurse.

  Recruiting Phase 2 Centre Oscar Lambret · Amiens and 2 other locations · NCT05500391

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.