Neoplasms

Digestive System Diseases

All Conditions

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Electromagnetic measurement to detect rectal cancer.

RC screening was carried out using a Tissue Resonance InterferoMeter probe electromagnetic detector, which consists of a nonlinear oscillator placed in a cylindrical probe about 30 cm long, a radiofrequency spectrum analyzer, and dedicated computer software. Detection of RC is based on the decrease of the electromagnetic signal compared to the mean signal obtained in healthy subjects. The test was performed while the patient stood 120 cm from the receiver. The operator was on the opposite side of the examined pelvis. The detector was kept at close contact to the pelvis surface and was moved through six planes, to obtain a scan of the whole pelvis volume. Based on our previous study, we used the electromagnetic detection system at 465 MHz frequency, in a scale from 0 to 255 arbitrary U.

Electromagnetic measurement

The aim of the present prospective study was to evaluate the prediction accuracy of electromagnetic detection of rectal cancer (RC). Eligible subjects were consecutively enrolled in the investigators' Institute and subjected to electromagnetic detection followed by colonoscopy and histopathologic analysis of biopsies. A putative RC carrier status was attributed to subjects showing an electromagnetic signal \< 50 units (U).

Eligibility criteria: Gastrointestinal disease or clinical symptoms related to colorectal cancer risk. Exclusion criteria consisted of age younger than 18 years, history of psychiatric illness, and preoperative radiotherapy.

Outcome measures: RC screening was carried out using a Tissue Resonance InterferoMeter probe (TRIMprobe) electromagnetic detector (Galileo Avionica, Turin, Italy), which consists of a nonlinear oscillator placed in a cylindrical probe about 30 cm long, a radiofrequency spectrum analyzer, and dedicated computer software. Detection of RC is based on the decrease of the electromagnetic signal compared to the mean signal obtained in healthy subjects. The test was performed while the patient stood 120 cm from the receiver. The operator was on the opposite side of the examined pelvis. No metallic objects were allowed on the patient and no electronic devices were admitted in the test area. The detector was kept at close contact to the pelvis surface and was moved through six planes, to obtain a scan of the whole pelvis volume. Based on the investigators previous study, we used the electromagnetic detection system at 465 MHz frequency, in a scale from 0 to 255 arbitrary U. The device lets the examination limited to the pelvis and we regarded the rectum cutoff within 15 cm from the anal verge.

Diagnosis of Rectal Cancer by Electromagnetic Device

Clinical Investigation on a Device for the Diagnosis of Rectal Cancer

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Ermanno Leo

Colonic Diseases

Six thousand persons eligible for the national CRC screening program will be selected. They will be selected from four areas that are considered representative of the Netherlands. All invitees receive an invitation to complete a FIT (FOB-Gold) and a validated, online family history questionnaire. Answers from the questionnaire are compared with the Dutch criteria for referral for genetic testing and/or surveillance colonoscopies for persons at a potential familial risk for CRC. Invitees are invited to perform both tests, but if they only perform one this will be assessed. Participants with a positive FIT and/or a positive family history and a diagnosis of familial CRC by a clinical geneticist will be referred for colonoscopy.

All invitees receive an invitation to complete a FIT (FOB-Gold) and a validated, online family history questionnaire. Answers from the questionnaire are compared with the Dutch criteria for referral for genetic testing and/or surveillance colonoscopies for persons at a potential familial risk for CRC. Invitees are invited to perform both tests, but if they only perform one this will be assessed. Participants with a positive FIT (cut-off value 275 ng/ml) and/or a positive family history and a diagnosis of familial CRC by a clinical geneticist will be referred for colonoscopy.

Family history questionnaire

Evelien Dekker, MD PhD

The aim of this study is to identify more persons with advanced neoplasia in the current national CRC screening, by adding data on family history of CRC (using a validated online questionnaire) to FIT. In addition, the aim is to identify those persons and their family members who should not be participating in a FIT based screening but receive surveillance colonoscopies instead, because of a familial CRC syndrome. It is aimed to increase detection without affecting participation, thereby increasing the yield of screening.

This is a prospective CRC population-based screening trial, using FIT and a family history questionnaire, inviting those with a positive FIT, a familial CRC syndrome, or both for colonoscopy.

All invitees receive an invitation to complete a FIT (FOB-Gold) and a validated, online family history questionnaire. Answers from the questionnaire are compared with the Dutch criteria for referral for genetic testing and/or surveillance colonoscopies for persons at a potential familial risk for CRC. Invitees are invited to perform both tests, but if they only perform one this will be assessed. Participants with a positive FIT (cut-off value 275 ng/ml) and/or a positive family history and a diagnosis of familial CRC by a clinical geneticist will be referred for colonoscopy.

The investigators will compare the diagnostic yield, participation rate, and positive predictive value for two strategies: referral for colonoscopy based on FIT and family history versus referral for colonoscopy based on FIT-only.

The sample size is justified by the anticipated gain in diagnostic yield from combining FIT-only with family history screening. With a sample size of 6.000 persons the investigators expect to detect 130 persons with advanced neoplasia after a positive FIT (21.7 per 1.000 invitees). By adding the family history questionnaire, the investigators anticipate detecting an additional number of 11 persons with advanced neoplasia, resulting in a yield of combined FIT-based and family history screening of 141 persons with advanced neoplasia (23.5 per 1.000 invitees), which is an increase of 1.8 per 1.000 invitees. Using the McNemar test with the significance level set at 5%, there is a power of 91% to show that the gain in diagnostic yield is statistically significant. Previous CRC test screening studies using FIT showed that participation rates are approximately 60% in a first screening round. The participation rate in the Dutch national CRC screening in 2014 (the first year of introduction) was even higher, 68%. The investigators expect that 80% of these persons will fill out the familial risk questionnaire, resulting in 3.264 persons who perform both tests. As the investigators recommend invitees to perform the questionnaire in addition to FIT, the investigators assume that the percentage of persons only filling out the questionnaire and not performing FIT are negligible. Based on previous screening studies using a FIT positivity cut-off value of 50 ng Hb/mL for the OC-Sensor, it is assumed that 8% of these participants have a positive FIT result. In the current Dutch screening program, a different FIT is used (FOB-Gold) with a cut-off value of 275 ng Hb/ml. The FIT positivity rate with this test and with this cut-off value is unknown. However, a governmental announcement recently reported that the positivity rate is expected to remain 8% with this cut-off value. Therefore, the investigators expect 326 FIT positives in this study (8% of 4.080). Based on previous studies, approximately 40% of all persons with a positive FIT result will have advanced neoplasia. In our sample this concerns 130 persons. The percentage of persons with a familial CRC risk requiring surveillance colonoscopies in a screening population varies between 2.3% and 4%. Differences in the definition of an increased familial CRC risk could explain the variability in reported numbers. As the investigators are using a relatively large range in criteria for fulfilling the definition of a familial CRC risk, the highest reported percentage (4%) is assumed, which concerns 131 persons. The previously developed family history questionnaire has a sensitivity of 90% and 100% in identifying those persons qualifying for referral, in two subsequent validation phases respectively. For the purpose of this study, this validated questionnaire is adjusted to the recently renewed referral criteria. The investigators make the assumption that the questionnaire can identify all persons with a familial CRC syndrome based on referral criteria. Persons with a familial CRC syndrome who do not fulfill these criteria will be missed. This concerns an unknown number and will not be taken into account. A previous screening study showed that 6% of those with a positive FIT have an increased familial CRC risk. One can calculate that 3.8% of persons with a negative FIT have a familial CRC risk: 4% minus 6% of 8% (FIT positives), divided by 92% (FIT negatives). If one assumes that there is no difference in familial CRC risk between those who do and those who do not fill out the questionnaire, this involves 114 of 3.264 persons. Based on unpublished data by this research group it is estimated that 10% of those with a negative FIT have a familial CRC risk: 11 persons (10% of 114). A similar percentage was found in another screening study. Additionally, all participants with a familial CRC syndrome will be offered surveillance recommendations. In this sample, 131 persons are estimated to have a familial CRC syndrome. Of these, 16 persons (12%) will undergo a colonoscopy due to a positive FIT (6% of 8% FIT positives) and their familial CRC risk could be addressed at their visit to a colonoscopy center. The other 115 persons (88%) are expected to have a negative FIT and these persons (and their family members) would otherwise be unlikely to be identified as having a familial CRC syndrome.

Adding Family History of Colorectal Cancer to the Dutch FIT-based Screening Program

Adding Family History of Colorectal Cancer to the FIT-based Screening Program in a Dutch Colorectal Cancer Population Sample

This will be analyzed in a telephone interview

number of participants in whom advanced neoplasia is detected relative to the number of invitees

Number of invitees completing the screening tests relative to the number of invitees

Number of participants in whom advanced neoplasia is detected, relative to the number of participants testing positive

Dutch Digestive Diseases Foundation

Prof. Evelien Dekker, MD, PhD

Professor MD

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Carcinoma

Melanoma

Skin Neoplasms

Carcinoma, Squamous Cell

Neoplasm Metastasis

Carcinoma, Basal Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Skin Diseases

Neoplasms, Basal Cell

Recruited family physicians and dermatologists in Calgary, Canada, take part in a 5.5-hour face-to-face skin cancer screening training program. Screening for skin cancer will be conducted by trained physicians according to instructions they received in the training program.

Recruited family physicians and dermatologists in Edmonton, Canada, WILL BE TRAINED AFTER THE SCREENING PHASE, i.e. during the screening phase non-trained physicians will carry out skin cancer screenings according to standard medical practice.

Topics of the 5.5-hour in-class course include: the screening test, types of skin cancer (signs and symptoms), case history taking, epidemiology of skin cancer, etiology, risk factors and risk groups, communicative aspects of primary and secondary preventive measures, and benefits and harms of cancer screenings.

Skin Cancer Screening Training

Lynne H Robertson, MD, FRCPC

Gordon E Searles, MD, FRCPC

Eckhard W Breitbart, MD, PhD

The overall aim of this population-based screening study is to assess whether the skin cancer screening training of family physicians and dermatologists leads to improved screening outcomes. The training course aims to increase the accuracy of detecting early stages of skin cancer. Screening outcomes of an intervention region (Calgary, Canada) in which physicians receive training will be compared with screening outcomes of a control region (Edmonton, Canada) where no physician training is administered.

The investigators will determine whether:

* clinical screening outcomes are more favorable in the group of trained physicians compared to non trained physicians
* there is an increase of knowledge about skin cancer screening among trained physicians, compared to non trained physicians
* skin cancer screenings are associated with psycho-social harms
* population-based screening has an effect on the overall incidence and stage-specific-incidence of skin cancer in Alberta

The investigators are aiming to recruit 100 physicians per region (total of 200 physicians) who will screen 40,000 to 80,000 individuals over a period of 20 months.

Skin Cancer Screening Education Study

Educational outcomes of physicians will be measured pre- and post-training using knowledge tests in the intervention and control region

Case report forms will be analyzed to determine clinical screening outcomes such as the NNS, NNE and tumor thickness.

A patient questionnaire will be used to assess psycho-social harms of skin cancer screenings.

University of Calgary

University of Alberta

Association of Dermatological Prevention, Germany

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

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

women will routinely be invited to attend for cervical screening via the SCCRS application.

Women aged under 30 years will be identified to receive an SMS following cervical screening invitation using information from the CHI Broadcast

A single SMS text sent to women under 30 who are eligible for the cervical screening programme and who have been invited by letter

SMS text

This study will pilot production and evaluate the use of reminder information in women invited for cervical screening for the first time within the GGC eligible population for cervical screening. Women aged under 30 years will be identified to receive an SMS text message following their cervical screening invitation using information from the CHI Broadcast.

Cervical cancer is the commonest cancer among women aged less than 35 years. A change to the age range and frequency for cervical screening was implemented on the 6th June 2016. This increased the younger eligible age for screening from 20 to 25. Uptake of cervical screening among women in the youngest eligible age range has historically been low. Research by Scott Porter has shown that cervical screening is not on young women's radar and additionally there is scope for confusion amongst women in this cohort about the requirement to attend for cervical screening if they have been previously immunised against HPV (human papilloma virus) generally in secondary school in year 2, some 12 years earlier.

The HPV vaccine was introduced in 2008 and is designed to protect against the two types of high risk HPV which cause approximately 75% of all cervical cancer. Advice to all eligible women who have been vaccinated remains that participation in cervical screening is necessary to provide the most comprehensive protection against cervical cancer, as the current vaccine does not provide protection against all high risk cancer causing strains of HPV.

Research from other screening programmes has also shown that where individuals engage with a screening programme from the start, they are more likely to continue to participate in screening for as long as they are eligible.

"Intending to, but not getting round to it", is the reason most associated with non-response to cervical cancer screening invitations.

GGC serves approximately 40% of the total Scottish population and therefore testing the reminder in the GGC population provides an opportunity to compare the impact of the SMS text reminder in this cohort with management as usual within the remainder of the Scottish eligible population. This should enable us to identify whether use of a reminder SMS text message is in fact likely to add value and increase participation in cervical screening.

The study arms are as follow:

1. No intervention: women will routinely be invited to attend for cervical screening via the SCCRS application.
2. Experimental: Women aged under 30 years will be identified to receive an SMS following cervical screening invitation using information from the CHI Broadcast

Cervical Cytology - Do SMS Reminders Increase Participation in the Cervical Screening Programme?

Number of women attending for cervical screening in intervention group compared to control group

Number of women attending cervical screening by level of deprivation (Scottish Index of Multiple Deprivation) (control vs intervention)

Number of women attending cervical screening by HPV vaccination status (control vs intervention)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Diagnosis of Rectal Cancer by Electromagnetic Device	NCT00963794	Rectal Cancer	Electromagnetic...	18 Years - 95 Years	Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Adding Family History of Colorectal Cancer to the Dutch FIT-based Screening Program	NCT02698462	Colorectal Neop...	Family history ...	59 Years - 75 Years	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Adding Family History of Colorectal Cancer to the Dutch FIT-based Screening Program	NCT02698462	Colorectal Neop...	Family history ...	59 Years - 75 Years	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Skin Cancer Screening Education Study	NCT02352428	Skin Tumors Melanoma Basal Cell Carc... Squamous Cell C...	Skin Cancer Scr...	20 Years -	Association of Dermatological Prevention, Germany
Skin Cancer Screening Education Study	NCT02352428	Skin Tumors Melanoma Basal Cell Carc... Squamous Cell C...	Skin Cancer Scr...	20 Years -	Association of Dermatological Prevention, Germany
Cervical Cytology - Do SMS Reminders Increase Participation in the Cervical Screening Programme?	NCT03975127	Cervical Carcin... Cervical Dyspla...	SMS text	22 Years - 29 Years	NHS Greater Glasgow and Clyde
Diagnosis of Rectal Cancer by Electromagnetic Device	NCT00963794	Rectal Cancer	Electromagnetic...	18 Years - 95 Years	Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Spots Global Cancer Trial Database for population screening