Neoplasms

All Conditions

Infections

Digestive System Diseases

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Papilloma

Virus Diseases

Anus Neoplasms

Carcinoma in Situ

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Anus Diseases

Rectal Diseases

Anal Cancer

Women with both genital HSIL/SCC and Anal HSIL/SCC

Dual Pathology

Micol Lupi

Christos Kontovounisios

Paris Tekkis

This is a retrospective cross-sectional study involving the analysis of Cancer Registry Data. As part of this study, cancer registration data collated by the National Cancer Registration and Analysis Service (NCRAS; the national cancer registry in England), via NHS Digital data access request service (DARS), will be analysed on all female patients aged between 25-90+ years in England with a registered diagnosis of anal and vaginal and/or vulvar and/or cervical cancer and/or high grade squamous intraepithelial lesions (HSIL) between 2001 and 2019. For these patients information on age at diagnosis, ethnicity, deprivation, performance status, stage of the cancer at diagnosis, the date of each diagnosis, the treatment received for the diagnosis and the route to diagnosis, will be analysed. Additionally, the total number of women/year (between 1995 and 2019), in England, aged between 25-90+ years with a diagnosis of anal, vulvar, vaginal and cervical cancer as well as their respective HSILs will be requested. Together this data will be used to establish the incidence of anal cancer and HSIL in women with genital cancers and/or HSILs, the progression timelines between the different pathologies, as well as identify relevant sociodemographic risk factors in this patient group.

Hypothesis: Women with genital HSILs/SCCs have an increased risk of anal HSIL/SCC regardless of whether they have received treatment for their genital condition and would benefit from surveillance and treatment of anal HSIL in the prevention of ASCC.

This is a retrospective observational (cross sectional) study in which de-personalised patient level National Cancer Registration and Analysis Service data via NHS Digital DARS will be requested.

In particular, patient level data for all women in England, between 2001 and 2019, aged 25- 90+ years, with a diagnosis of anal cancer and/or anal HSIL and:

* vaginal SCC and/or HSIL
* vulvar SCC and/or HSIL
* cervical SCC and/or HSIL
* vaginal and vulvar SCC and/or HSIL
* vaginal and cervical SCC and/or HSIL
* vulvar and cervical SCC and/or HSIL
* vaginal, cervical and vulvar SCC and/or HSIL

For these women with synchronous or metachronous anal and genital HSILs or SCCs data will be collected on:

1. Month, Year of each diagnosis.
2. Age at each diagnosis.
3. Cancer stage (for each cancer): 1, 2, 3, 4, not known, other, unstageable disease.
4. Performance status at each diagnosis: 1,2,3,4, not known.
5. Treatments received (for each diagnosis): Surgery, Chemotherapy, Radiotherapy.
6. Ethnicity: British, Irish, Other white, White/ Black Caribbean, White/Black African, White/ Asian, Other Mixed, Indian, Pakistani, Bangladeshi, Other Asian, Black Caribbean, Black African, Other black, Chinese, Other Ethnic, Not Known.
7. Route to Diagnosis (for each diagnosis): Emergency Presentation, GP referral, Inpatient Elective, Other Outpatient, Screening, Two Week Wait, Unknown.
8. Deprivation score: 1 (least deprived), 2, 3, 4, 5 (Most deprived).

In order to establish the incidence of anal cancer in women with genital cancers, data will be requested on the total number of women/year (between 2001 and 2019), in England, aged between 25-90+ years with a diagnosis of:

* Anal cancer
* Anal HSIL
* Vulvar cancer
* Vulvar HSIL
* Vaginal cancer
* Vaginal HSIL
* Cervical cancer
* Cervical HSIL

ICD-10 malignant neoplasm and carcinoma in-situ codes will be used to identify these patients:

* Anal Cancer C21.0. C21.1, C21.8
* Cancer of the Vulva C51.0, C51.1, C51.2, C51.8, C51.9
* Cancer of the Vagina C52.
* Cancer of the Cervix Uteri C53.0, C53.1, C53.8, C53.9
* Anal HSIL D01.3
* Vulval HSIL D07.1
* Vaginal HSIL D07.2
* Cervical HSIL D06.0, D06.1, D06.7, D06.9

Primary Objective:

Establish the incidence of anal HSIL and cancer in women with genital HSILs and/cancers and vice versa in England.

Secondary Objectives:

1. Asses the risk of anal HSIL and SCC in women with genital HSILs and/or SCC in England.
2. Investigate the sociodemographic risk profile of women developing multizonal anogenital HPV driven high-risk pathologies.
3. Establish the timelines between the development of genital HSIL/SCC and anal HSIL/SCC.

Primary Outcome:

The incidence of anal HSIL and cancer in women with genital HSIL and/cancer in England between 2001- 2019.

Secondary Outcomes:

1. The risk of anal HSIL and/or SCC in women with genital HSILs and/or SCC in England.
2. The relationship between the incidence of multizonal anogenital disease and specific sociodemographic risk factors (ethnicity, age, social deprivation).
3. The amount of time in years and months between the diagnosis of genital HSIL/SCC and anal HSIL/SCC.

Statistics and Data Analysis:

Data will be analysed using SPSS Statistics software. All outcomes extracted from the database will be expressed in categorical fields; therefore, comparisons of outcomes will be analysed using Chi squared or Fisher's Exact Tests. A statistically significant p value for this analysis is defined as p \< 0.05. Incidence will be calculated per 100,000 people per year. Any missing data fields were classified as "unknown" within the database. Missing data will not be excluded from the analysis and "unknown" variables are included with tables and figures to prevent bias.

Anal Cancer Risk In Women

The Role of Early Detection and Treatment of Anal Intraepithelial Neoplasia in the Prevention of Anal Squamous Cell Carcinoma in Women: Establishing the Disease Burden in Women With Genital Cancer

Request to NHS digital is for de-personalised data. Researchers will not have access to individual participant data.

Imperial College London

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Uterine Cervical Neoplasms

Endometrial Neoplasms

Vaginal Neoplasms

Vulvar Neoplasms

Genital Neoplasms, Female

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Uterine Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Vulvar Diseases

Vaginal Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Vaginal Cancer

Vulvar Cancer

Psychosocial

Laura Petersen

Carolyn Hagopian

Karen Livornese, BSN, RN

Cynthia A Perry, CIP

LTC G. Larry Maxwell, MD

Barbara L Andersen, PhD

The purpose of this study is to evaluate the quality of life of long-term gynecologic cancer survivors.

Since the early 1970s, death rates for the major gynecological tumors have significantly declined, with a reduction of 42% for endometrial, 49% for cervix, 27% for vagina and vulva, and 11% for ovarian cancer. Thus, of the approximately 82,000 new gynecologic cases each year, more women will be living and, necessarily be forced to cope with psychological or behavioral morbidity. Psychosocial data on cancer patients portray significant fear and anxiety with diagnosis and treatments and the potential for high levels of psychological and sexual morbidity. While many studies have been done investigating sexual outcomes, little data is available on basic domains of quality of life, i.e. emotional or social adjustment, occupational outcomes, or aspects of physical health that might influence quality of life for gynecologic cancer survivors. There is a need for basic descriptive research in these areas, particularly in investigations that include representative samples from differing socioeconomic and racial/ethnic groups.

The goal of the proposed study is to evaluate quality of life in long-term gynecologic cancer survivors. The specific aims are to:

1. Describe quality of life (both mental health and physical functioning components), stress, and sexual functioning among survivors of gynecologic malignancies and
2. Describe differences between disease site groups (i.e. cervical, endometrial, ovarian, and vulva).

It has been shown with other cancer groups that improvements in mood and coping can be achieved with brief, cost effective interventions (e.g. ten therapy hours with delivery in a group format). These are multi-modal interventions with stress reduction, disease/treatment information, cognitive behavioral coping strategies, and social support. There is suggestive evidence that disease specific interventions, such as including sexual therapies for gynecologic patients, can result in improvements as well. Research focus on these issues is aided by the availability of reliable and valid strategies to assess both quality of life (SF-36; FACT) and sexuality. Before clinical trials are undertaken, research must provide a comprehensive assessment of quality of life for gynecologic cancer survivors.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Anal Cancer Risk In Women	NCT05835947	Anal Cancer Human Papilloma... Anal Intraepith... Genital Neoplas... Genital Cancer	Dual Pathology	25 Years - 100 Years	Imperial College London
Questionnaire Study for Gynecological Cancer Survivors	NCT00391664	Endometrial Neo... Ovarian Neoplas... Uterine Cervica... Vulvar Neoplasm... Vaginal Neoplas... Genital Neoplas...	Psychosocial	20 Years - 75 Years	Walter Reed Army Medical Center

Spots Global Cancer Trial Database for genital cancer