Primary Organoid Models and Combined Nucleic Acids Therapeutics for Anti-HPV Treatments

NCT04278326 | Terminated

• 1 other identifier: CHRO-2019-08
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

Human papilloma virus (HPV) is responsible of the most common sexually transmitted infection. It can cause severe cancer lesions, of the cervix, vulva, vagina, penis and oropharynx. The International Agency for Cancer Research of World Health Organization (WHO) classified a dozen of HPV related high-risk cancer types, and recognized cervical cancer as the most common HPV-related disease. HPV 16 and 18 are responsible for 70% of cervical cancers. Due to the few symptoms of cervical cancer, women are often diagnosed with advanced state. Current treatments imply cervical conisation or hysterectomy, with or without lymphadenectomy and or radiotherapy, or chemotherapy. However, few pharmacological options are available against oncogenic papilloma viruses and thus against recurrences The aim of this project is to develop relevant organoids models from patient biopsies that will be used to identify biomarkers and evaluate in a closest preclinical setting novel nucleic acids based therapeutic strategy for HPV-cervical-vaginal dysplasia and cancers.

Conditions

HPV Infection; Vaginal Cancer; Cervical Dysplasia; Cervical Cancer

Keywords

vaginal organoid; human papilloma virus; nucleic acids; cervical dysplasia; cervical cancer

Outcome Measures

Primary Outcomes (1)

• To develop a 3D vaginal organoid culture model.

  The main objective is to develop a 3D cell culture model of organoid type from vaginal and cervical biopsies of patients infected with an oncogenic papilloma virus

  4 years

Secondary Outcomes (1)

• Inhibition of HPV molecular therapeutics using oligonucleotide, and siRNA (small interfering RNA)

  4 years

Study Arms (1)

Experimental

EXPERIMENTAL

1. Patients infected by oncogenic HPV and presented a high grade cervical dysplasia or a cervical cancer 2. Patients with cervical or vaginal cancer 3. All patients

Procedure: Vaginal Biopsy

Interventions

Vaginal Biopsy PROCEDURE

1. Vaginal biopsies 2. Additional cervical and vaginal biopsies 3. Non invasive cervico-vaginal swab like a smear

Experimental

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients between 18 and 75 years old.
• Patients presented with cervical or vaginal dysplasia or cancer induced by oncogenic HPV demonstrated by a PAP test and or HPV testing requiring a biopsy and histology in current care.
• Patients with previous history of conisation or hysterectomy for lesions of the cervix or the vagina caused by oncogenic HPV.
• To participate in the study, patients must sign an informed consent.

You may not qualify if:

• \- Pregnant women
• Patients with coagulation disorders
• Refusal of patients to participate in the trial Patients not affiliated to medical insurance
• Person deprived of their liberty by judicial or administrative decision
• Adults over 18 who are under legal protection measures or cannot give their consent

Sponsors & Collaborators

• Centre Hospitalier Régional d'Orléans: lead
• CNRS - Pr Chantal PICHON: collaborator

Study Sites (1)

CHR Orléans

Orléans, 45000, France

Location

Related Publications (5)

• Ngamkham J, Boonmark K, Phansri T. Detection and Type-Distribution of Human Papillomavirus in Vulva and Vaginal Abnormal Cytology Lesions and Cancer Tissues from Thai Women. Asian Pac J Cancer Prev. 2016;17(3):1129-34. doi: 10.7314/apjcp.2016.17.3.1129.

  PMID: 27039737 BACKGROUND

• Duke P, Godwin M, Ratnam S, Dawson L, Fontaine D, Lear A, Traverso-Yepez M, Graham W, Ravalia M, Mugford G, Pike A, Fortier J, Peach M. Effect of vaginal self-sampling on cervical cancer screening rates: a community-based study in Newfoundland. BMC Womens Health. 2015 Jun 10;15:47. doi: 10.1186/s12905-015-0206-1.

  PMID: 26060041 BACKGROUND

• Koo YJ, Min KJ, Hong JH, Lee JK. Efficacy of Poly-Gamma-Glutamic Acid in Women with High-Risk Human Papillomavirus-Positive Vaginal Intraepithelial Neoplasia: an Observational Pilot Study. J Microbiol Biotechnol. 2015 Jul;25(7):1163-9. doi: 10.4014/jmb.1503.03106.

  PMID: 25907060 BACKGROUND

• Mollers M, King AJ, Knol MJ, Scherpenisse M, Meijer CJ, van der Klis FR, de Melker HE. Effectiveness of human papillomavirus vaccine against incident and persistent infections among young girls: Results from a longitudinal Dutch cohort study. Vaccine. 2015 May 28;33(23):2678-83. doi: 10.1016/j.vaccine.2015.04.016. Epub 2015 Apr 14.

  PMID: 25887090 BACKGROUND

• Wang KD, Xu DJ, Wang BY, Yan DH, Lv Z, Su JR. Inhibitory Effect of Vaginal Lactobacillus Supernatants on Cervical Cancer Cells. Probiotics Antimicrob Proteins. 2018 Jun;10(2):236-242. doi: 10.1007/s12602-017-9339-x.

  PMID: 29071554 BACKGROUND

MeSH Terms

Conditions

Papillomavirus Infections; Vaginal Neoplasms; Uterine Cervical Dysplasia; Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Precancerous Conditions; Uterine Cervical Diseases; Uterine Diseases; Uterine Neoplasms

Study Officials

• Souhail ALOUINI, M.D.,Ph.D.

  CHR Orléans

  PRINCIPAL INVESTIGATOR

• Chantal PICHON, Ph.D.

  Centre National de la Recherche Scientifique, France

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2020
• First Posted: February 20, 2020
• Study Start: December 21, 2021
• Primary Completion: December 21, 2021
• Study Completion: December 21, 2021
• Last Updated: April 20, 2025

Record last verified: 2025-04

Locations

FR (1)