Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Infections

Rare Diseases

Uterine Cervical Neoplasms

Uterine Cervical Dysplasia

Papilloma

Virus Diseases

Precancerous Conditions

Neoplasms, Squamous Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Cervical Intraepithelial Neoplasia

Healthy women without HPV in their cervical and vaginal sample

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

Ahinoam Lev Sagie, MD

Lilah Tsaitlin Mor, MD

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.

Infection with high-risk Human Papillomavirus (HPV) genotypes constitutes a well-recognized risk factor for cervical-carcinoma (CC). High-risk HPV features 10-15% persistence rate, consequently driving precancerous cervical-intraepithelial-neoplasia (CIN) and subsequent progression to CC. Multiple factors are believed to play permissive roles in the progression of CIN/CC , yet a molecular mechanism driving carcinogenesis across the CIN-CC continuum following persistent HPV infection remains elusive. The vaginal microbiome may play a role in the development of CIN-CC carcinogenesis, by modulation of host-immune-response and alteration of cervical microenvironment to become tumor-permissive. While suggested vaginal microbiome contributions include induction of altered epithelial cell adhesion and downregulation of DNA damage responses, no clear mechanism has been proven to date. The loss of Lactobacillus genus dominancy, and the switch to dysbiotic, high-diversity, high-pH, Bacterial Vaginosis (BV) is thought to play a key-role in HPV infection, persistence and carcinogenesis.

the investigators hypothesize that specific vaginal microorganisms may promote HPV persistence, chronic inflammation and progression through the CIN-CC sequence, and the elimination of harmful bacteria or supplementation of beneficial microbes, could possibly reverse HPV persistency and inhibit CIN-CC progression.

The current study consists of recruitment of a human cohort of healthy, CIN and CC patients including vaginal samples and comprehensive metadata collection. The investigators plan to conduct an in-depth characterization of vaginal microbiome to identify associations with HPV, CIN and CC.

Vaginal for microbiome and molecular analysis, cytology and HPV PCR

Vaginal Microbiome and HPV Pre-malignant and Cervical Dysplasia

Assessing Personalized Vaginal Microbiome Contributions to HPV-driven Pre-malignant and Malignant Cervical Cancer

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

Hadassah Medical Organization

Professor

In physical activity experimental group, trained study nurses will interview with patients,give health education,teach how to use and record the Activity meter.Professionals will calculate Metabolic Equivalent of Task(MET) with formula weekly.MET = (intensity level 9 points \* time of each exercise (hours) \* Number of times per week + moderate level 5 points \* time per activity (hours) \* number of times per week + low level 3 points \* time per activity (hours) \* number of times per week),investigators hope patients in the first month MET can reach (3.75-7.49 MET-h/ week), and reach moderate or more than moderate activity (\>= 7.5-16.49 MET-h/ week) at the starting of second month for at least one year.

the non-physical activity group,investigators do not give them any physical interventions

Physical activity

Yu-Wen Su, Bs

Hsiu-Ting Tsai, Phd

Wen-Chi Liu, MSc

In this proposed project,investigators will estimate the effect of physical activity and abstain from smoking on the regression of precancerous neoplasia.

Cervical cancer is the seventh most common malignancy and the sixth most common cause of cancer-related death in Taiwan. The development of cervical cancer is passed through cervical intraepithelial neoplasia (CIN), including CIN I, CIN II, and CIN III. CIN I is classified as low-grade squamous intraepithelial lesion (LSIL), and about 57% of patients with CIN I are known to regress spontaneously, while patients with CIN II or CIN III is 5% and 15% to progress to invasive cervical cancer, respectively. Both two need active treatment and are classified as high-grade squamous intraepithelial lesion (HSIL). Fortunately, the 5-year survival rate is more than 90% for patients with CINs if they receive clinical management as soon as possible. The immunocompetence plays an important role for prevention of cervical cancer. High-risk human papillomavirus (HR-HPV) infection is demonstrated as one of the vital risk factors of CIN and cervical cancer. Most HPV infection is known to regress spontaneously by cell-mediated immunity, whereas a small fraction persistant HPV infection, which increase the risk of CIN and promote the progression to cervical cancer. Physical activity is reported to increase the cell number and activity of immune cells and promote cell-mediated cytotoxic effect to protect against HPV and cancer cells. Also, it is found that physical activity decrease the risk of breast cancer, hepatocellular carcinoma, colon cancer, and prostate cancer. Regular moderate intensity physical activity is ssociated with a decrease in the death from cancer. Moreover, tobacco smoke is reported to abate human immunocompetence and raise the risk of cervical cancer as well as to enhance the progression of CIN through the inhibition of cell-mediated immunity. Also, the extract of tobacco is demonstrated to enhance the proliferation and viral load of HPV, consequently induce carcinogenesis of cervical intraepithelial cells. Investigators suggest that physical activity could decrease the risk of CIN through promote cell-mediated immunity. Also, physical activity and abstain from smoking could be benefit to the regression of CIN and the decreasing of DNA viral load of HPV. However, the roles of physical activity and abstain from smoking on the regression of CIN and viral load are not fully clarified. Therefore, in this proposed project, investigators will 【1】estimate the effect of physical activity on decreasing the risk of cervical intraepithelial neoplasia. 【2】estimate the effect of physical activity on the regression of cervical intraepithelial neoplasia. 【3】estimate the effect of abstain from smoking on the regression of cervical intraepithelial neoplasia. 【4】estimate the additive effect and synergistic effect of physical activity and abstain from smoking on the regression of cervical intraepithelial neoplasia. 【5】estimate the effect of physical activity on the decreasing of DNA viral load of human papillomavirus. 【6】estimate the effect of abstain from smoking on the decreasing of DNA viral load of human papillomavirus. 【7】estimate the additive effect and synergistic effect of physical activity and abstain from smoking on the decreasing of DNA viral load of human papillomavirus

The Effect of Physical Activity and Abstain From Smoking on the Precancerous Lesion

The Effect of Physical Activity and Abstain From Smoking on the Regression of Precancerous Lesion.

To estimate the effect of moderate physical activity and abstain from smoking can strengthen the innate immune system,adaptive human immune system and can help regression of Cervical intraepithelial neoplasia among patients with cervical cancer.

Using a composite outcome measure consisting of questionnaire,blood counts,plasma and DNA.

blood counts :white blood cells,hemoglobin,red blood cells,platelets,Neutrophil,Lymphocyte,Monocyte,Eosinophil,Basophil,CD-4,CD-8,NK-cell,B-cell.

plasma:lL-1,IL-2,IL-4,IL-5,IL,6,LI-8,IL-10,IL-13,TNF-r

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Vaginal Microbiome and HPV Pre-malignant and Cervical Dysplasia	NCT05640700	Human Papilloma... Vaginal Flora I... Cancer Cervix U... Cervical Dyspla...		25 Years - 70 Years	Hadassah Medical Organization
The Effect of Physical Activity and Abstain From Smoking on the Precancerous Lesion	NCT03093623	Cancer Cervix U... Precancerous Le... Smoking	Physical activi...	20 Years - 70 Years	Taipei Medical University
The Effect of Physical Activity and Abstain From Smoking on the Precancerous Lesion	NCT03093623	Cancer Cervix U... Precancerous Le... Smoking	Physical activi...	20 Years - 70 Years	Taipei Medical University

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