Infections

All Conditions

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Communicable Diseases

Papillomavirus Infections

Disease Attributes

Sexually Transmitted Diseases

Sexually Transmitted Diseases, Viral

Virus Diseases

DNA Virus Infections

Tumor Virus Infections

Genital Diseases

Urogenital Diseases

In the enrollment, women who have undergone cervical cytology (TCT) examination for the last 3 months with abnormal results will be included in this study. All participants will be followed up three times, at 6 months, 12 months and 24 months.

Participants will be followed up at 6, 12 and 24 months with the test of enous blood, vaginal secretions, faeces, and cervical exfoliated cells.

Follow up

Pengming Sun, PhD.

There are different microbial communities on the surface of human body (skin, hair, nails, etc.) and in the cavity connected with the outside world. The human microbiota is the general term of the genetic information of microorganisms that coexist with human beings and cause various diseases under certain conditions. The results of human microbial genome analysis show that the microbial communities in different parts of the human body and different individuals have amazing diversity, some of which play an important role in human health, and some are closely related to diseases. Female lower genital tract infection is often associated with human papillomavirus (HPV) infection and bacterial vaginosis (BV), such as cervical and vaginal precancerous lesions, cancer, condyloma acuminatum and other sexually transmitted diseases (STD). Persistent infection of high-risk human papillomavirus (HR-HPV) is closely related to the occurrence of invasive cervical cancer. New evidence suggests that vaginal microbiota composition is different in women with HR-HPV infection and high-grade cervical lesions. The increase of the severity of cervical intraepithelial neoplasia is related to the decrease of the relative abundance of vaginal Lactobacillus. In addition to vaginal microbes, the powerful intestinal flora is considered to be the "invisible organ" of the human body. There is a dynamic and balanced interaction network between intestinal microorganisms and human immune cells. Once the intestinal flora is out of balance, the changes in species, quantity, proportion, location and biological characteristics will cause a series of inflammatory reactions and immune system diseases, and even lead to cancer. Some studies have shown that there is a potential relationship between intestinal microorganisms and vaginal microorganisms. Recent research evidence suggests that the mutually beneficial relationship between oral bacteria and other vaginal bacteria supports the colonization of pathogens and may help maintain the characteristics of vaginal flora imbalance.

Based on the clinical practice, this study carried out a multi center cohort study in Fujian Province, China. In this study, five research including Fujian Maternity and Child Health Hospital, Mindong Hospital of Ningde City, Zhangzhou affiliated Hospital of Fujian Medical University, Quanzhou First Hospital Afflicated to Fujian Medical University and Xiamen Maternity and Child Health Hospital Affiliated to Xiamen University were included, each of which included 600 individuals, with a total of 3000 women with potential cervical lesions were enrolled. Blood samples were tested for immunology, stool swabs and vaginal secretions were collected for microecological evaluation. At the same time, 21 kinds of common HPV virus types, cervical exfoliative cytology and 10 kinds of common STDs pathogens were detected. The included population will be tested with the same samples at 6, 12 and 24 months of follow-up to explore the relationship between vaginal, intestinal microorganisms and cervical HPV infection and the development of cervical lesions and its potential impact, so as to further explore the key factors affecting the persistent infection and clearance of HPV in female reproductive tract and the potential impact factors of the occurrence and development of cervical lesions. This prospective observational the characteristics of vaginal and intestinal microbiota in women with different cervical HPV infection, to evaluate the relationship and the underlying effect in the developoing of cervical lessions.

DNA specimens of exfoliated cervix cells；DNA samples of vaginal secretions.

Characteristics of Vaginal and Intestinal Microbiota and Cervical HPV Infection

Characteristics of Vaginal and Intestinal Microbiota in Women With Different Cervical HPV Infection

Cervical histopathology was performed at baseline for all participants.

Cervical histopathology was performed at 12-month follow-up for cervical HPV infection or cytology abnormalities women.

Cervical histopathology was performed at 24-month follow-up for cervical HPV infection or cytology abnormalities women.

All participants were tested for HPV DNA of cervical exfoliated cells at the time of baseline.

All participants were tested for HPV DNA of cervical exfoliated cells at the time of 6-month follow-up.

All participants were tested for HPV DNA of cervical exfoliated cells at the time of 12-month follow-up.

All participants were tested for HPV DNA of cervical exfoliated cells at the time of 24-month follow-up.

All participants were tested for cervical cytology at the time of baseline.

All participants underwent microbiological metagenomic sequencing of vaginal secretions at baseline.

All participants underwent microbiological metagenomic sequencing of vaginal secretions at 6-month follow-up.

All participants underwent microbiological metagenomic sequencing of vaginal secretions at 12-month follow-up.

All participants underwent microbiological metagenomic sequencing of vaginal secretions at 24-month follow-up.

All participants underwent fecal microbiome sequencing at baseline.

All participants underwent fecal microbiome sequencing at 6-month follow-up.

All participants underwent fecal microbiome sequencing at 12-month follow-up.

All participants were tested for microbial untargeted metabolites of vaginal secretions at baseline by liquid chromatography tandem mass spectrometric (LC-MS). Measure abundances of vaginal secretions metabolites, metabolic networks, and metabolic pathways activity.

All participants were tested for microbial metabolites of vaginal secretions at 6-month follow-up and 12-month follow-up by LC-MS. Change in vaginal secretions metabolome from baseline to 12-month follow-up were assessed.

All participants were tested for serum metabolites at enrollment by LC-MS. Measure abundances of serum metabolites, metabolic networks, and metabolic pathways activity.

All participants were tested for microbial metabolites of serum at 6-month follow-up and 12-month follow-up by LC-MS. Change in serum metabolome from baseline to 12-month follow-up were assessed.

All participants were tested for IL-6 (pg/ml), IL-8 (pg/ml), IL-1β (pg/ml) and other cytokines in vaginal secretions at enrollment.

All participants were tested for IL-6 (pg/ml), IL-8 (pg/ml), IL-1β (pg/ml) and other cytokines in vaginal secretions at 6-month follow-up.

All participants were tested for IL-6 (pg/ml), IL-8 (pg/ml), IL-1β (pg/ml) and other cytokines in vaginal secretions at 12-month follow-up.

All participants were tested for IL-6 (pg/ml), IL-8 (pg/ml), IL-1β (pg/ml) and other cytokines in vaginal secretions at 24-month follow-up.

Fujian Maternity and Child Health Hospital

Laboratory of Gynecologic Oncology

Neoplasms

Uterine Cervical Neoplasms

Papilloma

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Neoplasms, Squamous Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Anti-Infective Agents

All Drugs and Chemicals

Antineoplastic Agents

Micronutrients

Coagulants

Pharmaceutical Solutions

Vitamins

Acetic Acid

Retinol acetate

Iodine

Lugol's solution

Cadexomer iodine

Vitamin A

Retinol palmitate

Anti-Bacterial Agents

Adjuvants, Immunologic

Immunologic Factors

Protective Agents

Hemostatics

Retinol

A triage test that involved a gynaecological exam that applies acetic acid and then Lugol's iodine on the surface of the external os of the cervix.

VIA (Visual Inspection with Acetic acid) and VILI (Visual Inspection with Lugol's Iodine)

A triage test that involved a gynaecological exam that applies acetic acid on the surface of the external os of the cervix.

VIA (Visual Inspection with Acetic acid)

Selamawit Mekuria, MD

Mats Jerkeman, MD, PhD

Adamu Meghersa

Adane Mihret, PhD

The overall purpose of the project is to evaluate an algorithm for an HPV self-sampling based cervical cancer screening algorithm in a mid-size town in Ethiopia that could be applicable for nationwide implementation in low and middle-income countries (LMIC).

Specific aims are the following:

* To evaluate the algorithm using Visual Inspection with Acetic acid (VIA) and VIA together with Lugol's Iodine (VILI) as triage and to use HPV self-sample to follow up those treated and those with persisting HPV.
* To evaluate the prevalence of Chlamydia trachomatis, Neisseria gonorrhoeae and other STIs in the cohort.
* To determine immune response profiles in high-risk HPV-positive women who cleared, persisted, or developed Cervical Intraepithelial Neoplasia 2/3 (CIN).
* To assess how specific cervicovaginal microbiota compositions are associated with HPV infection, cervical dysplasia, and cancer

The whole cohort is offered an HPV self-sample. The HPV high risk positive women gets randomised into two arms VIA or VIA/VILI at the triage step.

Cervical Cancer Screening by Self-sampling in a Cohort of Younger Women in Ethiopia

Evaluation of an Human Papillomavirus (HPV) Based Screening Algorithm for Low and Middle Income Countries, by Self-sampling in Ethiopia

All HPV pos women will have a cervical biopsy taken

Chlamydia Trachomatis, Neisseria Gonnorhea, Ureaplasma Urelytikum/Parvum, Trichomonas Vaginalis, Mycoplasma Genitalium/Hominis

Assessed in HPV high risk pos women at initiation, who persist and who clear their infection

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Characteristics of Vaginal and Intestinal Microbiota and Cervical HPV Infection	NCT05003505	Intestinal Micr... Vaginal Microbi... HPV Infection	Follow up	20 Years - 65 Years	Fujian Maternity and Child Health Hospital
Cervical Cancer Screening by Self-sampling in a Cohort of Younger Women in Ethiopia	NCT05125380	Cervical Cancer STI Human Papilloma... Microbiota	VIA (Visual Ins... VIA (Visual Ins...	18 Years -	Lund University
Cervical Cancer Screening by Self-sampling in a Cohort of Younger Women in Ethiopia	NCT05125380	Cervical Cancer STI Human Papilloma... Microbiota	VIA (Visual Ins... VIA (Visual Ins...	18 Years -	Lund University

Spots Global Cancer Trial Database for vaginal microbiota