Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Disease Progression

Uterine Cervical Dysplasia

Precancerous Conditions

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

Group 1: normal pap smear Group 2: cervical neoplasia

Chih-Ming Ho

The investigators hypothesis is HPV integration could result in expression of oncogene transcripts, and not only constitutive expression but also the level of expression will be decisive for transformation and the maintenance of the malignant phenotype. Moreover, the expression and level of HPV viral transcripts not HPV DNA viral loads is correlated to the severity in cervical intraepithelial neoplasia (CIN) and cervical carcinomas (CxCa).

In the investigators proposal, the investigators will examine at least 250 baseline liquid-based cytology specimens from women with normal cytology, low-grade squamous intraepithelial lesions (LSILs), high-grade squamous intraepithelial lesions (HSILs), microinvasions and invasive cervical cancers. Specimens will be tested for HPV DNA using HPV blot and type-specific PCR including type 16, 18, 52, 58, 31, 33, 39, 45, 51, 56, 59, 68, 6, and 11. Cervical specimens from women with HPV DNA types 16, 18, 52, 58, 31 and 33, which are the most prevalent oncogenic types in Taiwan, will be examined for physical status of viral DNA tested by real-time PCR and FISH, along with level of expression in mRNA.

Comparison of Human Papillomavirus Integrated DNA and Messenger RNA in Cervical Neoplasia

Comparison of Human Papillomavirus Integrated DNA and Messenger RNA for Detection and Prediction in Progression of Cervical Neoplasia

National Science Council, Taiwan

Cathay General Hospital

Attending physician

Uterine Cervical Neoplasms

Tang-Yuan Chu, M.D., Ph.D.

The aims of this study are:

1. Surveillance of the prevalence of HPV infection in ASCUS, AGCUS and SIL cases pooled from medical centers in Taiwan and analysis of the related epidemiological factors.
2. Providing a better understanding of the natural history of HPV infection with its correlation with pathologic changes through a longitudinal follow-up of LSIL cases.

Carcinoma of the uterine cervix is by far the most prevalent cancer of women in Taiwan and worldwide. In 1994, it ranked the top of female cancer incidence with 3000 new cases annually and claimed nearly 1000 lives. The major cause of this malignant disease is now pointed to the infection of oncogenic types of human papillomavirus (HPV). HPV infection is sexually transmitted, affects the immature metaplastic cells of uterine cervix and, in an unknown proportion, results in squamous intraepithelial lesion (SIL) of differing severity. The natural history of HPV infection is by far elusive. It is not clear how the virus get into the cell, how the immune system respond to it, and how the epithelial cell get transformed. An average estimation holds that about 60% of low grade SIL will regress, 30% will persist, 10% will progress to high grade lesions and less than 1% become invasive lesions.

The aims of this study are:

1. Surveillance of the prevalence of HPV infection in ASCUS, AGCUS and SIL cases pooled from medical centers in Taiwan and analysis of the related epidemiological factors.
2. Providing a better understanding of the natural history of HPV infection with its correlation with pathologic changes through a longitudinal follow-up of LSIL cases.

Through a consensus of management of patients with abnormal Pap smear in TGOG, a standard protocol of specimen collection, clinical follow-up has been established. Patients with a Pap smear of ASCUS, AGCUS or SIL will be arranged with a repeat Pap smear and a colposcopy with or without biopsy. A cervical swab will be taken and sent to the core laboratory for HPV DNA detection and genotyping. Pap smear and biopsies were then panel-reviewed by Pathologists. Cytology-or pathology-proved LSIL cases will be followed every three months with Pap smear, colposcopy and HPV test until disease progression or two consecutive negative results of all the three data. One thousand cases fulfilling "aim 1" will be analyzed during the first year, and the nature course of about 300 LSIL cases will be followed at the end of the third year.

A Multi-center Survey of HPV in Cervical Intraepithelial Neoplasia (CIN) With Longitudinal Follow-up of LSIL Cases

National Health Research Institutes, Taiwan

Infections

Diseases and Abnormalities at or Before Birth

Immune System Diseases

Digestive System Diseases

Communicable Diseases

Congenital Abnormalities

Acquired Immunodeficiency Syndrome

HIV Infections

Papillomavirus Infections

Anus Neoplasms

Anal Cancer

Therefore, it is proposed we conduct a longitudinal study of the epidemiology of low risk and high risk HPV infection and related low grade and high grade anal cancers in HIV negative and HIV positive homosexual men who are 35 years or older. Participants are asked questions about recent experiences of anal intercourse in the last six months.

At baseline, all men (both HIV positive and HIV negative)will undergo a behavioural questionnaire, and anal swabs which will be tested for HPV and cytology. An HRA will also be performed on all men. Blood will be collected for HIV testing for HIV negative participants, syphilis and storage. Participants will be followed up for three years with one six-monthly visit in the first year then annually. A 6th study visit to discuss all study results will take place 2-3 months after the 5th study visit. A behavioural questionnaire, an anal swab, and HRA will be administered at all follow up interviews.

Participants asked questions about recent experiences of anal intercourse in the last six months.

The HRA is performed on HIV positive and HIV negative participants by study doctor after an examination of the perianal region and perineum. The plastic anoscope is inserted into the anal canal and visualised under high resolution magnification. Biopsy samples will be taken by the clinician for histological assessment if there are any detected abnormalities.

High Resolution Anoscopy

Carmella Law, MBBS; FAChSHM;

David Templeton, MBChB; PhD;

SPANC stands for Study of the Prevention of Anal Cancer. There are more than 100 types of human papillomavirus (HPV). Some HPV types cause genital warts and other types cause more than 90% of anal cancer.

Gay men are over 20 times more likely than others to develop anal cancer.

SPANC is a study of anal (HPV) infection and related anal disease in gay men. The study will provide important information to guide the possible future introduction of anal cancer screening programs for gay men.

Study title: The natural history of anal human papillomavirus (HPV) infection and anal cellular abnormalities in homosexual men.

Protocol version: 7, dated 1 September 2013. Approved by Ethics Committee on 24th October, 2013

Objectives: Among homosexual men aged 35 years or above to determine:

1. Prevalence, incidence and risk factors for specific types of HPV infection.
2. Prevalence, incidence and risk factors for histologically confirmed anal low grade and high grade squamous intraepithelial lesions (LSIL and HSIL).
3. Type-specific rates of clearance and persistence of anal HPV infection.
4. Rates of disease progression, regression and predictors in the spectrum of anal dysplasia.
5. Psychosocial/quality of life impact of anal cytology screening in homosexual men.

Study results will be used to inform possible development of guidelines for carrying out an anal cancer screening program in this population.

The study design is a prospective longitudinal design. Upon enrolment, participants will be followed up for three years to allow the study of both prevalence and incidence of HPV infection and related conditions.

Planned sample size: 600 homosexual men will be screened and enrolled from community based settings in Sydney, Australia.

The inclusion criteria are:

* male homosexual aged 35 years or above;
* HIV positive participants: documented to be HIV positive;
* HIV negative participants: tested HIV negative at recruitment; provision of informed, written consent.

The exclusion criteria are:

* participants unable to attend scheduled follow-up interviews or unwilling to undergo high resolution anoscopies (HRA);
* unable to understand English;
* having bleeding disorders or currently taking anti-anticoagulant medications; \*having previously received HRA;
* having ever been diagnosed with anal cancer.

Study procedures:

* At baseline, all men will undergo a behavioural questionnaire, and anal swabs which will be tested for HPV and cytology.
* An HRA will also be performed on all men.
* Blood will be collected for HIV testing for HIV negative participants, syphilis and storage. Participants will be followed up for three years with one six-monthly visits in the first year and then annually. A 6th study visit to discuss all study results will take place 2-3 months after the 5th study visit. A behavioural questionnaire, blood collection (except at six month); an anal swab and HRA will be administered at all follow up interviews.

The SPANC study is a prospective cohort study of the national history of anal human papillomavirus (HPV) infection and anal cellular abnormalities in homosexual men aged 35 years and above in Sydney. It is expected that the study results will be influential in the possible development of an anal cancer screening program in high-risk populations. Data on the natural history of anal HPV infection in homosexual men recruited from community-based settings are rare. We aim to recruit a total of 600 men, 360 HIV-negative and 240 HIV-positive. This will make the SPANC study one of the biggest ongoing anal HPV natural history study in the world to provide critical data on the incidence and clearance of anal HPV infection, progression and regression of pre-cancerous HPV associated anal lesions, the potential psychological impact on men who participate anal cancer screening programs, and the cost-effectiveness of rolling out these programs.

Statistical considerations: Sample size calculation: Assuming the incidence of HSIL is 5 and 15 per cent 100 person-years in HIV negative and HIV positive men, respectively, the 95% confidence intervals will be 4.2-6.0 in the HIV negative arm and 12.6-17.8 per 100 person-years in the HIV positive arm. Analysis plan: HPV prevalence and incidence, including overall, low risk, high risk and individual types, will be calculated according to participant's HIV status. Prevalence and incidence of LSIL and HISL will be calculated in the same fashion. Clearance and persistence of HPV infection, and progression and regression of HSIL will also be determined. Risk factors for prevalent HPV infection and LSIL and HSIL will be analysed using logistical regression. Risk factors for incident conditions will be analysed using Cox regression.

Duration of the study: The study will take place from 13/September/2010 to 21/Dec/2018. Participants will be recruited from 2010 to 2015 and followed up for three years.

Study of the Prevention of Anal Cancer

The Natural History of Anal Human Papillomavirus Infection and Anal Cellular Abnormalities in Homosexual Men

Aims to determine the prevalence, incidence and risk factors for type-specific HPV (37 types)

To determine if HPV is associated with LSIL and HSIL

Kirby Institute

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Comparison of Human Papillomavirus Integrated DNA and Messenger RNA in Cervical Neoplasia	NCT02198365	Cervical Intrae...		20 Years - 80 Years	Cathay General Hospital
A Multi-center Survey of HPV in Cervical Intraepithelial Neoplasia (CIN) With Longitudinal Follow-up of LSIL Cases	NCT00201370	Cervical Cancer Low-grade Squam... Human Papilloma...		20 Years - 75 Years	National Health Research Institutes, Taiwan
Study of the Prevention of Anal Cancer	NCT02007421	Human Papilloma... Cancer	Participants as... High Resolution...	35 Years -	Kirby Institute

Spots Global Cancer Trial Database for human papillomavirus,