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

  • STATUS
    Recruiting
  • End date
    Apr 21, 2024
  • participants needed
    50
  • sponsor
    Centre Hospitalier Régional d'Orléans
Updated on 21 April 2022
cancer
hysterectomy
lymphadenectomy
dysplasia
primary cancer
human papillomavirus
sexually transmitted infection
hpv vaccine
pap smear
smear
severe cancer
human papilloma virus vaccine
papilloma
cone biopsy
PAP test
lab tests
cancer of the cervix
vaginal dysplasia
high-risk cancer
vaginal biopsy

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.

Description

In this project, the investigators want to develop organotypic culture of primary-derived biopsies, and combine them with organ-on-a-chip technology, to better characterize the HPV infection and cancer progression, as well as to screen innovative treatments for cervical and vaginal cancers.

Our study will cover cervical dysplasia and cervical cancers HPV induced. The investigators will perform cervical and or vaginal biopsies from patients with oncogenic HPV lesions. A protocol validated to collect biopsies from precancerous cervico-vaginal lesions or cervical cancer patients in CHRO (Orleans, France). The biopsies will be performed during a consultation in the Hospital center of Orleans, or in the theatre room during a conisation or an hysterectomy. The PRIMMO platform is the research platform of Regional hospital center of Orleans (CHRO) dedicated to the promotion of translational research. It will be involved in the collection, analysis and biobank storage setup of the project. Fresh samples will be collected and bring directly to the lab for organoid cell culture development. Detection of HPV in each biopsy will be carried out by the PRIMMO platform.

The organoid development from patient biopsies will take place into the lab of the Biophysic Molecular center in Orleans.

The organoids will be selected according to three criteria: their ability to grow until a first passage, their doubling time and their ability to be frozen and resuscitated. Such organoids maintain pathogen-host interaction and better model physiopathology of vaginal cervical dysplasia CIN2-3 or cervical cancer and thus allow for the detection of biomarkers for pre-cancerous lesions. In addition, organoids reduce the use of animal models and can be used for drug screening, In a second step, the investigators propose to use mRNA to produce in situ the nanobodies targeting E6 and E7, to inhibit viral replication and tumor growth

Socio-epidemiological data will be collected for each patient, in the form of a table.

The study could be stopped in case of serious undesirable events. Safety evaluation As this is a category 2 study, no particular vigilance linked to the research protocol will be useful.

However, the monitoring and reporting of unexpected events resulting from participation in the study will be declared to the "materiovigilance site" of the CHR of Orleans Given the minimal risks associated with the study, an independent monitoring committee was not considered necessary.

Details
Condition HPV Infection, Vaginal Cancer, Cervical Dysplasia, Cervical Cancer
Treatment Vaginal Biopsy
Clinical Study IdentifierNCT04278326
SponsorCentre Hospitalier Régional d'Orléans
Last Modified on21 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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