Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Infections

Rare Diseases

Uterine Cervical Neoplasms

Carcinoma

Papilloma

Virus Diseases

Uterine Cervical Dysplasia

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Neoplasms, Squamous Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Precancerous Conditions

Cervical Intraepithelial Neoplasia

This control group will receive no intervention. Cervical cancer screening (having a Pap smear taken by a clinician for cytology-based screening) is completely opportunistic, i.e. based on the initiative of the participant or their clinician.

No reminder letter will be sent.

This control group will receive the standard (recall) invitation letter send out by the Centre for Cancer Detection (CvKO). In this invitation letter, participants are encouraged to make an appointment with their clinician to have a Pap smear taken (for cytology-based screening).

A reminder letter will be sent after 5-6 months.

Women will receive a first-void urine self-sampling study package at home.

The study package will include an invitation letter/informed consent form, information brochure, first-void urine self-sampling device, safety bag with absorbent paper, pre-stamped return envelope, and instructions explaining how to collect the sample and send it to the lab.

A reminder letter will be sent after 5-6 months.

Women will receive a letter at home with instructions how to order (via phone, e-mail, or webform) a first-void urine self-sampling study package.

The study package will include an invitation letter/informed consent form, information brochure, first-void urine self-sampling device, safety bag with absorbent paper, pre-stamped return envelope, and instructions explaining how to collect the sample and send it to the lab.

A reminder letter will be sent after 5-6 months.

Women will receive a vaginal self-sampling study package at home.

The study package will include an invitation letter/informed consent form, information brochure, vaginal self-sampling device, safety bag with absorbent paper, pre-stamped return envelope, and instructions explaining how to collect the sample and send it to the lab.

A reminder letter will be sent after 5-6 months.

Women will receive a letter at home with instructions how to order (via phone, e-mail, or webform) a vaginal self-sampling study package.

The study package will include an invitation letter/informed consent form, information brochure, vaginal self-sampling device, safety bag with absorbent paper, pre-stamped return envelope, and instructions explaining how to collect the sample and send it to the lab.

A reminder letter will be sent after 5-6 months.

Women will self-collect a first-void urine sample at home upon receipt of the study package using the Colli-Pee Small Volumes (10 mL) device (Novosanis, Belgium). The collector tube is prefilled with a preservative (UCM, Novosanis, Belgium). Women will send the collector vial containing first-void urine along with the informed consent form to the laboratory at University of Antwerp using the prestamped envelope.

Colli-Pee Small Volumes

Women will self-collect a vaginal sample at home upon receipt of the study package using the Evalyn Brush device (Rovers Medical Devices, The Netherlands). Women will send the used brush along with the informed consent form to the laboratory at University of Antwerp using the prestamped envelope.

Evalyn Brush

Severien Van Keer, MSc, PhD

Alex Vorsters, Ir, PhD

Pierre Van Damme, MD, PhD

The goal of the ScreenUrSelf trial is to increase cervical cancer screening attendance and compliance to follow-up by offering a first-void urine self-sampling alternative to women who are currently not participating in the organized cervical cancer screening program (defined in this project as un(der)-screened women), either on the woman or her physician's personal initiative, or by responding on the invitation letter.

Patient: In this population-based study we target real un(der)-screened women, i.e., women (31-64y) eligible for the Flemish population-based cervical cancer screening program without any cytology/histology/pathological result retrieved from the Belgian Cancer Registry (BCR) for at least the last six years (i.e., two screening rounds). Women who opted out of the screening program, who are pregnant (self-reported), underwent total hysterectomy, have (had) cervical or uterine cancer, or are included in other Centre for Cancer Detection (CvKO) pilot projects are not eligible.

Intervention: The proposed randomized controlled trial (RCT) will be embedded in the Flemish organized cervical cancer screening program, which is coordinated by CvKO under governance of the Flemish government. The goal is to reach women who are eligible but do not participate in cervical cancer screening, by offering two self-sampling methods (first-void urine and vaginal) in an opt-in and -out strategy (total of four interventions) to collect samples for primary high-risk (hr) Human Papillomavirus (HPV) testing, and if positive, reflex 1) cytology on a Pap smear (standard of care) and 2) methylation marker triage (index test).

Comparison: The two control arms include 1) no intervention; and 2) sending (recall) invitation letters to women, inviting them to make an appointment for a Pap smear (i.e., current practise within the organized cervical cancer screening program in Flanders).

Primary outcome: The primary outcome is the actual response rate, i.e., proportions of women that participate in each intervention and in the control arms at 12 months after initiation of the intervention (the intervention being one of six study arms). Response in this project is defined as having a preventive cervical screen exam, either by a self-sample or by a physician-taken Pap smear, at 12 months after initiation of the intervention.

Cervical Cancer Screening Based on First-void Urine Self-sampling to Reach un(Der)-Screened Women: ScreenUrSelf Trial

Proportions of women that participate in each intervention (measured by PP\* and ITT\*) and in the control arms (measured by Pap smears taken) within 10 months after the intervention.

\*PP: participation in intervention arm measured by self-sample analyses only

\*\*ITT: participation in intervention arm measured by self-sample analyses or Pap smears taken

1. Compliance to a hrHPV positive result on a self-sample measured by standard of care follow-up, i.e., a Pap smear taken by a clinician.
2. Compliance to an abnormal Pap smear measured by standard of care follow-up.

Preference and attitudes of women between intervention arms (measured via a questionnaire)

Age-related differences in response rates within and between different study arms

Response rates: Proportions of women that participate in each intervention (measured by PP\* and ITT\*) and in the control arms (measured by Pap smears taken) within 10 months after the intervention.

\*PP: participation in intervention arm measured by self-sample analyses only

\*\*ITT: participation in intervention arm measured by self-sample analyses or Pap smears taken

Socio-economic status-related differences in response rates within and between different study arms

Response rates: Proportions of women that participate in each intervention (measured by PP\* and ITT\*) and in the control arms (measured by Pap smears taken) within 10 months after the intervention.

\*PP: participation in intervention arm measured by self-sample analyses only

\*\*ITT: participation in intervention arm measured by self-sample analyses or Pap smears taken

Test-positivity, positive predictive value, referral rate to colposcopy, and detection rate of CIN2+ of a hrHPV positive result on a self-sample in un(der)-screened women; absolute measures in each arm and ratios of measures between arms.

Test-positivity, positive predictive value, referral rate to colposcopy, and detection rate of CIN2+ will be combined to report clinical accuracy.

Test-positivity, positive predictive value, referral rate to colposcopy, and detection rate CIN2+ of a methylation-based reflex test (index test) to triage hrHPV positive self-sample in un(der)screened women, compared to reflex cytology on a Pap smear (comparator test); absolute measures in each arm and ratios of measures between arms.

Test-positivity, positive predictive value, referral rate to colposcopy, and detection rate of CIN2+ will be combined to report clinical accuracy.

1. Differences in time needed per women to obtain a test result between study arms
2. Differences in costs per women between the different study arms
3. Differences in total cost between the different study arms

The above differences in time and costs will be combined to report cost-effectiveness.

Antwerp University Hospital (UZA)

Centre for Cancer Detection (CvKO)

Sciensano

Universiteit Antwerpen

Principal Investigator

Participants will be mailed a Self-Sampling kit (Evalyn Brush) to collect samples for analysis for HPV/Cervical cancer screening.

The Evalyn Brush is a self-sampling kit that can be used to collect a sample to screen for HPV/Cervical cancer at home.

Jennifer Moss, PhD

This study seeks to compare the accuracy and acceptability of HPV testing self-sampling kit and standard clinician-sampling for HPV testing. The primary outcome of this study is the concordance between screening results on self-sampling kits compared to clinician-collected HPV test, Pap smear results, and colposcopy. Secondary endpoints will include acceptability of self-sampling and barriers to cervical cancer screening. These endpoints will be analyzed to try to circumvent barriers to the cervical cancer screening and ascertain whether self-sampling is a viable alternative.

The American Cancer Society estimates that 4,170 women in the United States (US) will die from cervical cancer in 2018 (Siegel et al., 2018). Screening can reduce cancer mortality by (1) detecting malignancies when they are more treatable and (2) for some tests, identifying precancerous lesions for removal (Shieh et al., 2016). Guidelines recommend cytology and/or HPV testing for cervical cancer screening among women ages 30-65 years, but screening rates are suboptimal (U.S. Preventive Services Task Force, 2018; Saslow et al., 2012).

To help bridge these gaps in screening, HPV self-sampling would be an alternative to clinical-sampling for HPV testing. However, there are concerns about the comparability and acceptability of self-sampling kits.

The main objective of this study is to compare the test characteristics of the human papillomavirus (HPV) self-sampling kit versus clinician-sampled HPV testing for cervical cancer screening. Potential participants will be identified from the Penn State Family and Community Medicine and OBGYN clinics after it is determined that they have abnormal findings on their (clinician-sampled) Pap/HPV test and require a follow-up colposcopy. The patient will be pre-screened by a study team member. If they are found to be eligible, a study team member will invite them to participate in the study.

After a participant enrolls in the study, a self-sampling kit is mailed to their home along with a Summary Explanation of Research consent form and instructional sheet. Participants will be asked to complete the kit two weeks before or after their colposcopy, giving them a 28 day collection window. Study team members will perform a follow-up survey after the sample is collected and provide reminder phone calls if needed.

Participants who enroll in the study will be asked to complete an HPV self-sampling kit in addition to completing their colposcopy exam. Participants will collect the sample at home before or after their exam and mail it back to the Penn State Health laboratory for analysis. The results will be compared to those of the clinician-collected (standard of care) colposcopy exam, Pap, and HPV test. Participants will also complete a follow up survey over the phone after their sample is collected.

Self-sampling for Human Papillomavirus (HPV) Among Patients Receiving Colposcopy

HPV Self-sampling Among Women at the Penn State Hershey Colposcopy Clinics

The primary outcome of this study is to analyze the number of participants with concordance of screening results of the self-sampling kit compared to clinician-collected HPV test, Pap smear results, and colposcopy.

The number of participants provided a kit vs. those who completed the sample collection

The number of participants, among those who completed the sample collection, who reported problems using the self-sampling kit.

Milton S. Hershey Medical Center

Assistant Professor

Participants were those scheduled for a colposcopy procedure due to abnormal findings during their recent standard-of-care, clinical-collected cervical cancer screening.

Participants

The participants in this study were scheduled for a colposcopy procedure due to abnormal findings during their recent standard-of-care, clinical-collected cervical cancer screening.

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

annual household income

small sample size due to slow participant accrual, exclusion of patients who do not engage in health care (group most likely to benefit from self-sampling)

Jennifer L. Moss, PhD

Number of Participants With Concordance of Screening Results of the Self-Sampling Kit Compared to Clinician-collected Samples

Total number of participants who were provided with a self-sampling kit.

Number of Completed Self-Sampling Kits

Total number of participants who returned the self-sampling kit.

Number of Participants Who Reported Problems Using Self-Sampling Kits

Overall Study

In the experimental arms, the woman will be asked to collect a vaginal sample with the Evalyn® Brush or a urine sample with the Colli-PeeTM. Women shall receive this self-sampling device directly from the GP or shall pick it up at a close by pharmacist with a prescription of the GP. In four GP practices (1, 2, 5, 6) the patient has to collect the SS preferentially in the GP practice (at home if the GP practice is not well equipped) whereas in the other four GP practices (3, 4, 7, 8), the patient has to collect the SS at home and send it to the laboratory by using a prepaid envelope.

Women in the control group will receive an oral recommendation given by the GP with a reminder of the current screening policy to have a cervical sample taken by a physician chosen by the woman. This clinician-taken cervical sample will be sent to a laboratory for processing with the usual screening test. Today the usual screening test still is cytology, but this will change in the future (date to be defined) to an HPV test.

The GP will hand over the self-sampling kit to the women, after obtaining informed consent, and the women then takes the self sample at home or in the doctor's office (predefined), according to the respective users manual.

ColliPee

Marc Arbyn, MD

Cindy Simoens, PhD

Guy Beuken, MD

Laura Prud'homme, MD

Julie Gosuin, MD

Anais Bosefe, MD

Small scale data indicate that cervical cancer screening participation may increase when self-sampling (SS) devices are offered directly by health care workers to non-screened woman, when those woman contact health services for whatever reason. The purpose of the current research is to reproduce the early findings of a MSc project conducted in a general practitioners (GP) group practice in Brussels, where women not screened since \>3 years randomized to direct reception of a SS kit yielded a response of 78% vs 51% in the control arm.

BELGSSAR will also investigate whether GP's have the information on the most important risk factors for cervical cancer available in their patient files.

Screening with clinically validated high-risk (hr) HPV tests is more effective in reducing cervical cancer incidence than cytology. Another advantage of hrHPV testing is that it can be performed on self-samples whereas cytology on self-samples shows poor clinical accuracy. hrHPV DNA testing on vaginal self-samples is as accurate on self- as on clinician-taken samples under the condition to use clinically validated PCR-based assays that target DNA sequences of the viral genome.

Offering kits for vaginal self-sampling is more effective than conventional invitations / reminders sent to under-screened women to have a cervical specimen taken by a clinician. Small scale data indicate that screening participation may increase when self-sampling (SS) devices are offered directly by health care workers to non-screened woman, when those woman contact health services for whatever reason. The purpose of the current research is to reproduce the early findings of a MSc project conducted in a general practitioners (GP) group practice in Brussels, where women not screened since \>3 years randomized to direct reception of SS kit yielded a response of 78% vs 51% in the control arm.

Risk based cervical cancer screening takes risk factors into account to differentiate screening policies. GPs have knowledge of these risk factors. Demonstration of the knowledge of these risk factors from GP's patient files will be demonstrated through the BELGSSAR trials.

Two self-sampling methods will be used in BELGSSAR:

1. vaginal self-sampling using the Evalyn® Brush (Roovers, Oss, NL) and
2. first-void urine collection with the Colli-PeeTM (Novosanis, Wijnegem, BE). Depending on the GP practice, collection will take place at home or at the GP office (predefined by the respective GP). The inclusion of urine collection is motivated by the possible lower threshold for women who dislike genital examinations.

The following hypotheses will be investigated:

1. Participation in cervical cancer screening is substantially higher when a GP offers a self-sampling kit compared to control interventions.
2. Risk factors for cervical cancer can be identified accurately from GP's patient files.

To test these hypotheses, a two-arm participation trial will be conducted in eight GP practices in Belgium, spread over four locations (Ghent, Leuven, Brussels and Liège). In each GP practice the enrolled patients will be randomized to one of the two study arms.

In the experimental arms (Arm 1), the woman will be asked to collect a vaginal sample with the Evalyn® Brush or a urine sample with the Colli-PeeTM. Women shall receive this self-sampling device directly from the GP or shall pick it up at a close by pharmacist with a prescription of the GP. In four GP practices (1, 2, 5, 6) the patient has to collect the SS preferentially in the GP practice (at home if the GP practice is not well equipped) whereas in the other four GP practices (3, 4, 7, 8), the patient has to collect the SS at home and send it to the laboratory by using a prepaid envelope.

Women in the control group (Arm 2) will receive an oral recommendation given by the GP with a reminder of the current screening policy to have a cervical sample taken by a physician chosen by the woman. This clinician-taken cervical sample will be sent to a laboratory for processing with the usual screening test. Today the usual screening test still is cytology, but this will change in the future (date to be defined) to an HPV test.

Double blinding of patient and investigator is not possible, because the participants will be aware to which study arm they belong when they receive or offer the self-sample.

All samples collected under the experimental arms will be handled and tested for presence of hrHPV types at the AML laboratory in Antwerp. AML is the national reference laboratory for HPV for Belgium. The used HPV assay will be the RIATOL qPCR, that detects E6/E7 HPV genes, with measurement of type-specific viral load of all high-risk HPV types. This test is clinically validated for HPV-based cervical cancer screening. The tests performed in the control arm will be processed in the laboratories connected with the respective GP practices.

Increase in Response by Offering Self-sampling Devices in Belgian GP Practices to Non-screened Women

Randomized Participation Trials: Increase in Response by Offering Self-sampling Devices in Belgian GP Practices to Non-screened Women

Difference in response in women included in the self-sampling arms vs the control arm (per protocol (PP) and intention to treat analyses \[ITT\]).

The absolute difference in response rate = proportion with screening test in experimental arm - proportion with screening test in control arm, within 6 months after enrolment.

In the PP analysis only women with a screening test on the self-sample according to the specific experimental intervention will be taken into account, whereas in the ITT analysis all screening tests performed within 6 months after enrolment will be considered (also those performed on samples taken by a clinician).

Horizon 2020 - European Commission

Women will receive a first-void urine self-sampling study package at home.

The study package will include an invitation letter/informed consent form, information brochure, first-void urine self-sampling device, safety bag with absorbent paper, pre-stamped return envelope, and instructions explaining how to collect the sample and send it to the lab.

Women will receive a letter at home with instructions how to order (via phone, e-mail, or webform) a first-void urine self-sampling study package.

The study package will include an invitation letter/informed consent form, information brochure, first-void urine self-sampling device, safety bag with absorbent paper, pre-stamped return envelope, and instructions explaining how to collect the sample and send it to the lab.

Women will receive a vaginal self-sampling study package at home.

The study package will include an invitation letter/informed consent form, information brochure, vaginal self-sampling device, safety bag with absorbent paper, pre-stamped return envelope, and instructions explaining how to collect the sample and send it to the lab.

Women will receive a letter at home with instructions how to order (via phone, e-mail, or webform) a vaginal self-sampling study package.

The study package will include an invitation letter/informed consent form, information brochure, vaginal self-sampling device, safety bag with absorbent paper, pre-stamped return envelope, and instructions explaining how to collect the sample and send it to the lab.

The proposed study is the Dry Run preceding the ScreenUrSelf trial.

The ScreenUrSelf trial will be embedded in the Flemish organized cervical cancer screening program. The goal of ScreenUrSelf is to reach women who are eligible but do not participate in cervical cancer screening, by offering two self-sampling methods (first-void urine and vaginal) in an opt-in and -out strategy (total of four interventions) to collect samples for primary high-risk (hr) Human Papillomavirus (HPV) testing, and if positive, reflex 1) cytology on a Pap smear (standard of care) and 2) methylation marker triage (index test). The two control arms include 1) no intervention; and 2) sending (recall) invitation letters to women, inviting them to make an appointment for a Pap smear (i.e., current practice within the organized cervical cancer screening program in Flanders).

The Dry Run which is the subject of this clinical trial will test the study materials and data flows developed for the interventional study arms (C, D, E and F) of the ScreenUrSelf trial. The primary outcome of the Dry Run is to check if the flow for data- and sample collection is ready for start of the ScreenUrSelf trial, and if optimizations are deemed necessary before start of the trial.

Dry Run of the ScreenUrSelf Trial

Cervical Cancer Screening Based on First-void Urine Self-sampling to Reach un(Der)-Screened Women: Dry Run of the ScreenUrSelf Trial

HPV DNA concentration \[copies/µl DNA\] in self-samples from all study participants.

Human DNA concentration \[copies/µl DNA\] in self-samples from all study participants

Preferences and attitudes of women regarding self-sampling (measured using a questionnaire)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Cervical Cancer Screening Based on First-void Urine Self-sampling to Reach un(Der)-Screened Women: ScreenUrSelf Trial	NCT05996783	Cervix Cancer Cervical Intrae... Human Papilloma... HPV-Related Cer...	Colli-Pee Small... Evalyn Brush	31 Years - 64 Years	Universiteit Antwerpen
Self-sampling for Human Papillomavirus (HPV) Among Patients Receiving Colposcopy	NCT04585243	HPV	Evalyn Brush	30 Years - 65 Years	Milton S. Hershey Medical Center
Self-sampling for Human Papillomavirus (HPV) Among Patients Receiving Colposcopy	NCT04585243	HPV	Evalyn Brush	30 Years - 65 Years	Milton S. Hershey Medical Center
Increase in Response by Offering Self-sampling Devices in Belgian GP Practices to Non-screened Women	NCT04903561	Cervical Cancer	ColliPee	30 Years - 64 Years	Sciensano
Dry Run of the ScreenUrSelf Trial	NCT05996796	Cervical Cancer Cervical Intrae... Human Papilloma... HPV-Related Cer...	Colli-Pee Small... Evalyn Brush	30 Years - 64 Years	Universiteit Antwerpen
Increase in Response by Offering Self-sampling Devices in Belgian GP Practices to Non-screened Women	NCT04903561	Cervical Cancer	ColliPee	30 Years - 64 Years	Sciensano
Dry Run of the ScreenUrSelf Trial	NCT05996796	Cervical Cancer Cervical Intrae... Human Papilloma... HPV-Related Cer...	Colli-Pee Small... Evalyn Brush	30 Years - 64 Years	Universiteit Antwerpen

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