Vaginal Microbiome and HPV Pre-malignant and Cervical Dysplasia

NCT05640700 | Recruiting

• 1 other identifier: HMO-812-21
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, the investigators will prospectively collect, analyze and integrate information regarding vaginal microbiome composition and HPV presence in women with cervical pathologies (high-grade CIN and CC) and controls, to construct a large dataset from patients with pre-cancerous cervical lesions and healthy women, to evaluate the personalized contribution of the vaginal microbiome to the CIN-CC sequence.

Conditions

Human Papilloma Virus; Vaginal Flora Imbalance; Cancer Cervix Uterus; Cervical Dysplasia

Outcome Measures

Primary Outcomes (1)

• Characterization of the microbiome using molecular methods.

  Comparison of microbiome profiles between those with HPV compared to controls without HPV.

  1 year

Study Arms (2)

Controls

Healthy women without HPV in their cervical and vaginal sample

Women with HPV

Women with HPV, with or without cervical intraepithelial neoplasia or carcinoma

Eligibility Criteria

• Age: 25 Years - 70 Years
• Gender Eligibility Details: people with cervix uterus
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

1\) Individuals that underwent an HPV PCR cervical screening test and were found to be negative for HPV (healthy controls, n=45) 2) Women that were found to be positive for high risk-HPV but have no cervical dysplasia (n=30) 3) Women who are positive for high risk-HPV and exhibit cervical pathology, either high-CIN (CIN 2-3) or CC (n=15).

You may qualify if:

• Age 25-70
• Attended the clinic for a Pap smear or colposcopy

You may not qualify if:

• Patient does not approve sample collection
• Usage of antibiotics in the month prior to clinic visit
• Usage of any vaginal preparation or medication in the week prior to sample collection (anti-fungal, spermicides, lubricant etc.)
• Menstruation
• Pregnancy

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah Medical Center

Jerusalem, Israel

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Vaginal for microbiome and molecular analysis, cytology and HPV PCR

MeSH Terms

Conditions

Uterine Cervical Dysplasia

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Ahinoam Lev Sagie, MD

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahinoam Lev Sagie, MD

CONTACT

+972-54-4327178; levsagie@netvision.net.il

Lilah Tsaitlin Mor, MD

CONTACT

+972-54-7753434; lilah.tsaitlin@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 28, 2022
• First Posted: December 7, 2022
• Study Start: November 9, 2022
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: March 19, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)