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

Blood and Lymph Conditions

Behaviors and Mental Disorders

Lymphedema

Lymphatic Diseases

Quality of Life

Patients diagnosed with curable gynaecologic cancer and accepting to participate before start of any gyneco-oncologic treatment.

Patients in the observational cohort, who develop early stage lymphedema (ISL stage 0-1): they will enter a randomized non-blinded interventional subgroup, comparing standard of care preventive measures only or in combination with compressive garments (compression class II)

Daily wearing of compressive garments, especially during prolonged standing upright or strenuous activities.

Compressive garments class II

Chris Monten, MD, PhD

Caren Randon, MD, PhD

Chris Monten, M.D., PhD

Caren Randon, M.D., PhD

Nele Devoogdt, PhD

Trial developed to inventory the incidence of early and advanced stage lower limb lymphedema in patients diagnosed with and treated for gynaecologic cancer.

Four hundred patients with diagnosis stage 1-3 gynaecologic cancer will be included in an observational cohort at the moment of diagnosis and followed for occurrence of lower limb lymphedema up till 2 years after their last treatment.

Data on signs and symptoms, quality of life, time investment and financial expenses will be collected, to provide information on the incidence and risk factors for lower limb lymphedema, and on its impact on patients, regarding quality of life, sexual well-being and time- and financial investment.

Patients developing early stage LLL enter an interventional sub-cohort, in which the effect of class II compressive garments on preventing evolution towards advanced stage LLL will be evaluated.

Context of the problem: Improved knowledge on the diagnosis and treatment of cancer has resulted in an increased number of cancer survivors. Consequently, more patients are confronted, often life-long, with the complications of their cancer treatment. These chronic conditions impact daily functioning and quality of life (QoL), complicate the return to work and undermine psycho-social well-being. One of the most frequent and disabling complications is lymphedema, a condition undermining QoL to an extent exceeding even a 10-year age increase.

The damage of lymphedema covers many aspects of daily life: it changes body image and complicates daily activities as basic as clothing, it increases patient-related health expenditures for treatment and for coping with the disease, reduces patient autonomy in daily functioning and can even cause sensory or motor dysfunctions. So far, no definitive cure exists for lymphedema: patients are confined to life-long preventive measures, compression therapy and regular manual lymph drainage. Surgical repair may be an option in selected cases, but evidence on surgical techniques is limited and their long-term effects are still unknown. Moreover, even after successful repair, conservative treatment is still needed.

Most studies on lymphedema are limited to upper limb lymphedema (ULL), mainly after breast cancer treatment. Only a few publications focus on lower limb lymphedema (LLL), despite its detrimental impact on QoL. This could be due to the difficulties to diagnose and treat LLL in comparison to ULL: LLL often occurs bilaterally or at the level of the groins or genital region, hence impeding diagnosis through comparison. Perimetric measurement of large cone-like oedematous legs is cumbersome. Manual lymph drainage and application of compressive garments is more strenuous for legs than for arms, and the typical bilateral occurrence and large volumes of LLL inflate the cost of treatment garments. However limited, some groups did evaluate the incidence of LLL after pelvic treatment, but maintained the criteria for advanced stage lymphedema as cut off, thereby underestimating the prior phases in which patients are confronted with functional impairment due to LLL, without apparent swelling.

The observational cohort in this study is aimed at inventorying the incidence, timing and risk factors of early as well as advanced stage lymphedema. Time and cost-investment of patients for prevention and/or treatment of LLL will be analyzed. The impact of LLL on QoL and on sexual well-being will be calculated.

A sub-cohort of this trial is of interventional design: in patients, included in the observational cohort and developing early stage LLL, standard of care treatment will be started, including skin care, active exercises and manual lymph drainage. In the experimental group, compressive garments class II will be added and compliance as well as tolerance of these garments will be analyzed.

Side-kicks of this trial are the standardization of perimetric measurements of the legs, validation of a self-report LLL screening tool and testing of the sensitivity and specificity of ICG fluoroscopy to detect early stage LLL.

Lymphedema After Gyneco-oncologic Treatment

Lower Limb Lymphedema After Gyneco-oncologic Therapy: Can we Prevent Irreversible Lymphedema?

Satisfaction with compressive garments assessed with ICC compression questionnaire, evaluation of functioning, symptoms of LLL, side-effects of compressive garments, feasibility of use, frequency and duration of wearing, autonomy, improvement or deterioration of functioning on social and job-level

Comparison of evolution of leg circumference measurement between the intervention group (compressive garments and the control group (no compressive garments), measuring leg circumference every 4cm, starting from a fixed point above the ankles to 17 measuring points above. Estimation of volume per leg is based on the truncated cone formula.

Inventory of mean time-investment of patients in the treatment of LLL through app-based registration, and comparison of time-investment between control group (no compressive garments) and interventional group (with compressive garments)

Inventory of mean financial investment of patients in the treatment of LLL through app-based registration, and comparison of time-investment between control group (no compressive garments) and interventional group (with compressive garments)

Number of patients with transition (evolution) to stage 0-3 LLL (ISL criteria) in the first two years after treatment for gynecologic cancer.

We defined three potential transitions:

* T1: from no LLL to reversible stage 0-1 LLL
* T2: from no LLL to irreversible stage 2-3 LLL
* T3: from stage 0-1 LLL to stage 2-3 LLL

Number of patients diagnosed with stage 0-1 LLL within one year after treatment for gynecologic cancer and that evolve from stage 0-1 LLL to stage 2-3 LLL

Registration of the timing of development of the different stages of LLL within the first two years after end of treatment

Age: the amount of time something has been alive or has existed (years)

Weight: In the operational definition, the weight of an object is the force measured by the operation of weighing it, which is the force it exerts on its support, expressed in kilograms (kg)

Height: measure of vertical extent (how "tall" something or someone is) (expressed in meters)

Body mass index (BMI) is a value derived from the mass (weight) and height of a person. The BMI is defined as the body mass divided by the square of the body height, and is expressed in units of kg/m2, resulting from mass in kilograms and height in metres.

Physical activity is defined as any voluntary bodily movement produced by skeletal muscles that requires energy expenditure. Physical activity encompasses all activities, at any intensity, performed during any time of day or night. It includes both exercise and incidental activity integrated into daily routine. This integrated activity may not be planned, structured, repetitive or purposeful for the improvement of fitness, and may include activities such as walking to the local shop, cleaning, working, active transport etc.

Expressed in intensity level (categorical)

Civil status, or marital status, are the distinct options that describe a person's relationship with a significant other. Married, single, divorced, and widowed are examples of civil status.

Expressed in definition (categorical - married, divorced, widowed, single...)

Obstetrical history: medical specialty dealing with the care of all women's reproductive tracts and their children during pregnancy (prenatal period), childbirth and the postnatal period Obstetric state: gravida - partus - abortus - mater

The International Standard Classification of Education (ISCED 2011) is a statistical framework for organizing information on education maintained by the United Nations Educational, Scientific and Cultural Organization (UNESCO). It is a member of the international family of economic and social classifications of the United Nations.

Categorical: lower secondary education, upper secondary education, Bachelor's or equivalent, Master's or equivalent, Doctorate or equivalent...

Work or labor (or labour in British English) is intentional activity people perform to support themselves, others, or the needs and wants of a wider community Categorical: unemployed, employee, self-employed, retired, student, work-incapacity...

Smoking is a practice in which a substance is burned and the resulting smoke is typically breathed in to be tasted and absorbed into the bloodstream.

Expressed in categories (never, used to smoke, active smoker)

Smoking is a practice in which a substance is burned and the resulting smoke is typically breathed in to be tasted and absorbed into the bloodstream.

A pack-year is a clinical quantification of cigarette smoking used to measure a person's exposure to tobacco. This is used to assess their risk of developing lung cancer or other pathologies related to tobacco use.

Calculation: Number of pack-years = (number of cigarettes smoked per day/20) × number of years smoked. (1 pack has 20 cigarettes in some countries)

An alcoholic drink (also called an alcoholic beverage, adult beverage, or simply a drink) is a drink that contains ethanol, a type of alcohol produced by fermentation of grains, fruits, or other sources of sugar that acts as a drug.

Expressed in categories: never, occasionally, daily

Human physical appearance is the outward phenotype or look of human beings. Registered as importance adhered to physical appearance on a rating scale from 1 to 10.

Expressed on a scale of one to ten, (this scale is a general and largely vernacular concept used for rating things, people, places, ideas, and so on. The scale has 10 as a maximum score, as a denotation of exceptionally high quality or of another attribute, a minimum of 0.)

Household income is an economic standard that can be applied to one household, or aggregated across a large group such as a county, city, or the whole country. It is commonly used by government and private institutions to describe a household's economic status or to track economic trends.

Expressed in categories (per month): \<1500, 1500-3000, \>3000-5000, \>5000 or 'does not wish to respond'

Allergies, also known as allergic diseases, are a number of conditions caused by hypersensitivity of the immune system to typically harmless substances in the environment.

The medical history, case history, or anamnesis of a patient is information gained by a physician by asking specific questions, with the aim of obtaining information useful in formulating a diagnosis and providing medical care to the patient.

Expressed in relevant categories (cardiac, renal, vascular, cancer, auto-immune...)

A pain scale measures a patient's pain intensity or other features. Pain scales are a common communication tool in medical contexts, and are used in a variety of medical settings.

Expressed on a scale of one to ten, (this scale is a general and largely vernacular concept used for rating things, people, places, ideas, and so on. The scale has 10 as a denotation of exceptionally high pain, and a minimum of 0 for no pain at all.)

The TNM Classification of Malignant Tumors (TNM) is a globally recognised standard for classifying the extent of spread of cancer. It is a classification system of the anatomical extent of tumor cancers.

Most common tumors have their own TNM classification. Sometimes also described as the AJCC system.

TNM is a notation system that describes the stage of a cancer, which originates from a solid tumor, using alphanumeric codes:

T describes the size of the original (primary) tumor and whether it has invaded nearby tissue, N describes nearby (regional) lymph nodes that are involved, M describes distant metastasis (spread of cancer from one part of the body to another).

The International Federation of Gynaecology and Obstetrics, usually just FIGO as the acronym of its French name Fédération Internationale de Gynécologie et d'Obstétrique, is a worldwide non-governmental organisation representing obstetricians and gynaecologists in over one hundred territories.

The FIGO staging system is used most often for cancers of the female reproductive organs, including cervical cancer, endometrial cancer, ovarian cancer...

As a rule, the lower the number, the less the cancer has spread. A higher number, such as stage IV, means a more advanced cancer. And within a stage, an earlier letter means a lower stage. Cancers with similar stages tend to have a similar outlook and are often treated in much the same way.

Gynecological surgery refers to surgery on the female reproductive system usually performed by gynecologists. In the domain of cancer it may include hysterectomy, ovariectomy, pelvic exenteration, salpingoophorectomy, vulvectomy and partial or complete lymphadenectomy

Systemic therapy is a therapy that is given in addition to the primary or initial therapy to maximize its effectiveness. It can be given in adjuvant or neo-adjuvant setting.

Categorical: none, taxanes, cisplatinum, immunotherapy, target therapy, anti-hormone therapy, other.

Radiation therapy or radiotherapy, often abbreviated RT, RTx, or XRT, is a therapy using ionizing radiation, generally provided as part of cancer treatment to control or kill malignant cells and normally delivered by a linear accelerator. Radiation therapy may be curative in a number of types of cancer if they are localized to one area of the body. It may also be used as part of adjuvant therapy, to prevent tumor recurrence after surgery to remove a primary malignant tumor (for example, early stages of breast cancer). Radiation therapy is synergistic with chemotherapy, and has been used before, during, and after chemotherapy in susceptible cancers.

Expressed per target volume in dose per fraction, number of fractions

EQ-5D is a standardised measure of health-related quality of life developed by the EuroQol Group to provide a simple, generic questionnaire for use in clinical and economic appraisal and population health surveys. EQ-5D assesses health status in terms of five dimensions of health and is considered a 'generic' questionnaire because these dimensions are not specific to any one patient group or health condition. EQ-5D can also be referred to as a patient-reported outcome (PRO) measure, because patients can complete the questionnaire themselves to provide information about their current health status and how this changes over time. 'EQ-5D' is not an abbreviation and is the correct term to use when referring to the instrument in general.

Expressed as an overall measure of self-assessed health status (EQ VAS) at different time points (D0, M3, M12)

European Organisation for Research and Treatment of Cancer (EORTC): qlq C30: questionnaire developed by the EORTC and validated in over 100 languages, in order to assess in 30 questions the quality of life of cancer patients.

Lymphoedema Functioning, Disability and Health Questionnaire for Lower Limb Lymphoedema (Lymph-ICF-LL): it is a descriptive, evaluative tool containing 28 questions about impairments in function, activity limitations, and participation restrictions in patients with lower limb lymphedema. The questionnaire has 5 domains: physical function, mental function, general tasks/household activities, mobility activities, and life domains/social life.

Female Sexual Distress Scale Revised (FSDS-R) is a multi-dimensional self-reporting questionnaire containing 13 items to evaluate sexual distress in women.

Evaluation: Percentage of patients with clinically relevant loss in sexual well-being, measured through questionnaire at baseline, 3 months, 12 months and 24 months post-treatment

The self-report lower-extremity lymphedema screening questionnaire is a screening questionnaire developed to detect lower-extremity lymphedema (LEL) among normal-weight women and women with obesity.

Evaluation: Number of patients with score \>5 on the self-report LLL questionnaire that are diagnosed with LLL according to ISL criteria (positive predictive value)

Percentage of positive ICG fluoroscopy (image of splash, stardust or diffuse ICG pattern) corresponding with positive lympho-scintigraphy (signs of impaired lymphatic flow) or with clinical diagnosis of LLL based on ISL criteria

Calculation of mean time investment of patients in the prevention and treatment of LLL through app-based registration

Calculation of mean financial investment of patients in the prevention and treatment of LLL through app-based registration

Development of standardized instructions for perimetric measurement with measurement from a fixed start point and then every 4cm to calculate leg circumference. Verification of reliability through intra- and interobserver comparison

University Hospital, Louvain

Kom Op Tegen Kanker

University Hospital, Ghent

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Uterine Cervical Neoplasms

Genital Diseases, Female

Uterine Neoplasms

Genital Neoplasms, Female

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

An invitation to order a HPV self sampling test through an online application will be sent by SMS or electronic letter.

2019-2021 - A Cobas PCR Female swab sample packet will be sent. Response rates (participation) will be measured.

2022 and onwards - A FLOQSwab and corresponding sample tube for analysis on the BD COR platform will be sent.

Sending of screening summon.

Miriam Elfström, PhD

Helena Andersson, PhD

Viviann Mattsson, MD

Christer Borgfeldt, MD, PhD

Katarina Kylebäck, MD

Mirjam Våtz, Midwife

Hanna Milerad, MD

Lovisa Bergengren, MD, PhD

Prevention of cervical cancer with cervical screening is one of the most successful screening activities in medicine. In Sweden, screening was implemented in the 1960s and has since prevented tens of thousands of women from having cervical cancer. Individual invitations to screening result in increased attendance therefore evaluating strategies for reaching women through invitations is particularly valuable. Women who regularly attend screening following an invitation reduce their risk of cervical cancer by as much as 90%. Of the women who are diagnosed with cervical cancer (about 550 women per year in Sweden), as many as 38% did not participate in the screening. Invitations for screening are sent to the entire population in Sweden aged 23-70. The current coverage of screening is 82.9%, which represents the proportion of women ages 23-70 who attend according to recommendations. In addition, many women are sporadic attenders who reduce their risk for cancer somewhat. The highest cancer risk is seen among those women who have never participated as well as women who have had a history of precancerous lesions or HPV infection but have not been followed-up. Cervical cancer is the first form of cancer for which there are approved molecular screening tests (HPV test). Unlike the older screening method (cytology), self-collected samples can be analyzed for HPV (the analysis method is so sensitive that it does not matter if the sample is not optimally taken).

Invitations and reminders about cervical screening are sent by letter to the woman's home address (about 3 million letters per year in Sweden). This strategy results in a waste of resources and has a negative environmental impact. Regarding reminders, we have seen in previous research that the effect is not optimal. When sending a physical reminder letter to women who have not participated in more than 10 years (current routine), only 2% of the women invited came for sampling. Reminders with SMS are now standard for many businesses in society, such as car testing or dental appointments. It is inexpensive, saves the environment and there are studies that suggest it is more effective than sending physical letters. In this study, we intend to investigate whether SMS reminders, electronic letters, and physical letters for screening lead to increased participation and thus to a higher proportion of detected, treatable precursors of cervical cancer compared to before.

Non-participation in the cervical screening program and sub-optimal follow-up after abnormalities or infection with a highly oncogenic HPV type detected in screening are the main risk factors for cervical cancer. Given this, It is important to reduce barriers to screening and facilitate participation in the screening program of cervical cancer. Offering self-sampling kits for human papillomavirus (HPV) testing has been examined in several research studies as a way to reach women who have not responded to screening invitations. Women who have been lost to follow-up can also be reached with self-sampling.

The purpose of this study is to investigate whether SMS reminders and electronic letters for screening attendance will increase participation compared to the current method where reminders are sent out with physical letters. In this study, women a with high risk of developing cervical cancer, due to not fully participating in screening or being followed up optimally, will be invited. Women are identified through registry linkages annually that examine screening history and status using a risk algorithm. Women receive an SMS or an electronic letter with an offer to request a self-sampling kit via the internet. Women with a higher risk for cervical cancer can be offered a self-sampling kit sent directly to their home address. The self-sampling kit comes with an instruction on how to take the sample and a postage-free answer envelope.

Submitted samples are analyzed with an approved and accredited method (Cobas 4800, Roche) that analyzes for HPV 16, HPV18 and other oncogenic HPV types. As the screening program changed the accredited HPV test in 2022 (to BD Onclarity), that test will be used from the timepoint of the change and onwards.

In the pilot of the study, follow-up is defined as follows:

1. For those women who are at the highest risk (previous glandular cell changes without follow-up), all HPV-positive women are referred via SMS directly to a women's clinic for investigation. HPV-negative women in this group have no increased risk and receive a text message with a calming message.
2. Women of an age above the screening program but who have either had a cell change that is not followed up or who have not participated at all in the last 10 years are treated in the same way as in paragraph 1.
3. Finally, the women of screening age who have not taken a cell sample for more than 15 years are identified. This group receive an SMS and HPV-positive women are referred, via SMS, for renewed sampling by a specially trained so-called dysplasia midwife. The sample is now being analyzed for both cytology and HPV. If the woman is HPV positive in both tests and in the case of deviating cytology, the woman is referred to a women's clinic. In other cases a text message with a reassuring message is sent.

The study has the usual level of confidence (p \<0.05 two-sided) and statistical power (80%) the ability to demonstrate an increase of participation by 3 times or more.

The protocol was piloted in the Region of Skåne in 2019 and then rolled out nationally in 2020.

The study is rolled out nationally with annual linkages to identify women with an excess risk for cervical cancer and an adaptive approach to reaching women with SMS, electronic letters, and physically letters with direct delivery of HPV self-sampling kits or an option to order a self-sampling kid (depending on risk). The study is coordinated centrally and each region has a contact person to whom women who need follow-up are referred.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
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
Lymphedema After Gyneco-oncologic Treatment	NCT05469945	Lymphedema Genital Neoplas...	Compressive gar...	18 Years - 99 Years	University Hospital, Ghent
SMS-based Summons in Cervical Screening	NCT04061967	Cervical Cancer Uterine Cervica... Uterine Neoplas... Genital Neoplas... Genital Neoplas... Uterine Disease... Genital Disease... Neoplasms by Si... Neoplasms Uterine Cervica...	Sending of scre...	33 Years - 75 Years	Karolinska Institutet
SMS-based Summons in Cervical Screening	NCT04061967	Cervical Cancer Uterine Cervica... Uterine Neoplas... Genital Neoplas... Genital Neoplas... Uterine Disease... Genital Disease... Neoplasms by Si... Neoplasms Uterine Cervica...	Sending of scre...	33 Years - 75 Years	Karolinska Institutet

Spots Global Cancer Trial Database for genital neoplasm