Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Breast Neoplasms

Neoplasm Metastasis

Breast Diseases

Skin Diseases

The additional MRI will take place biennially after the regular screening mammogram for a study period of 6 years.

No further follow-up until next scheduled screening examination two years later (according to the current Dutch guideline).

Gadolinium contrast is administered as a bolus with a standard dose of 0.1 mL/kg followed by a saline flush of 30 mL.

Contrast enhanced breast MRI

Carla H van Gils, PhD

Wouter B Veldhuis, MD PhD

The purpose of this study is to determine the cost-effectiveness of biennial screening with mammography and MRI compared to mammography alone in women aged 50-75 years and who show \> 75% mammographic density.

Women with very high mammographic density have a four to six fold higher breast cancer risk than women with low mammographic density. At the same time, the sensitivity of mammography is seriously impaired in women with high mammographic density, leading to many missed cases. Nevertheless, in the Netherlands this high risk group is currently screened between the age of 50 and 75 years with mammography only. MRI is likely to lead to better detection of breast tumors in women with high mammographic density, because it has a much higher sensitivity than mammography. The DENSE trial investigates the additional value of MRI for breast cancer screening in this risk group. Participants with extremely dense breasts (ACR4) and a negative mammogram are randomized to 'additional MRI' (n=7,237) versus 'current practice' (n=28,948).

Breast Cancer Screening With MRI in Women Aged 50-75 Years With Extremely Dense Breast Tissue: the DENSE Trial

The intervention will be carried out for six years, i.e. 3 screening rounds. Given a two year recruitment period, the total study time will be 8 years.

The MRI examination will take place every two years (0, 2 and 4 years after inclusion). Given a two year recruitment period, the total study time will be 6 years.

Dutch Breast Cancer Screening Organisations

Dutch Reference Centre for Screening

National Institute for Public Health and the Environment (RIVM)

The Netherlands Cancer Institute

University Medical Center Nijmegen

Jeroen Bosch Ziekenhuis

Albert Schweitzer Hospital

Hospital Group Twente (ZGT)

Amsterdam UMC, location VUmc

Maastricht University Medical Center

ZonMw: The Netherlands Organisation for Health Research and Development

Dutch Cancer Society

Pink Ribbon Inc.

A Sister's Hope

Bayer

Stichting Kankerpreventie Midden-West

Volpara Solutions

UMC Utrecht

Professor of Clinical Epidemiology of Cancer

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Uterine Cervical Neoplasms

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

The control arm corresponds to women receive a conventional invitation letter sent by post to the home address of eligible women recommending them to make an appointment to a doctor or a midwife for the collection of a cervical specimen.

eligible women receive at their home address a vaginal self-sampling kit in addition to the conventional invitation letter

eligible women receive at their home address a urine collection kit in addition to the conventional invitation letter

eligible women receive at their home address a self-sampling kit in addition to the conventional invitation letter

self-sampling

Anne-Sophie Banaszuk, MD

The cervical cancer screening coverage remains moderate (60%) in France. The aim of the study is to evaluate the efficacy of two experimental invitation strategies (offer of urine or vaginal self-sampling kits) to reach under-screened populations and compare them with the current invitation strategy in rural departments (low medical density and low participation rate) in France.

The study is a randomised controlled trial with three arms: a control arm (conventional invitation letter) and two experimental arms (mailing of a urine or vaginal self-sampling kit). The target population includes women aged 30-65 years, who had no screening test recorded since more than four years and who did not respond to an invitation letter within twelve months before. The primary outcome measure is the participation rate in each arm.

A team of psychologists will also investigate attitudes and experiences by semi-structured/focus-group interviews with voluntary CapU4 participants and with health professionals.

CapU4 will identify effective strategies to reach women not responding to current screening invitations and will generate information about acceptance of self-sampling among women and health professionals.

Research question: does the offer of self-sampling kits result in higher attendance to cervical cancer screening compared to sending invitation letters which recommend women to contact a health professional for taking a cervical specimen?

Systematic reviews indicate that Human Papillomavirus (HPV) testing on vaginal specimens taken by the woman her-self is as accurate to detect cervical precancer as HPV testing of cervical specimens collected by a clinician, under the condition that a validated polymerase chain reaction (PCR)-based HPV assay is used. Similar results are shown from recent studies where HPV testing was performed on first-void urine collected with an appropriate device and transport medium. A recent meta-analysis of randomised trials showed higher response rates when under-screened women receive a self-sampling kit at home compared to traditional invitation or reminder letters. However, the absolute participation rates are highly variable among studies. Whereas qualitative research indicates that women prefer collection of urine rather than a vaginal self-sample, no data are available that the offer of urine kits would result in higher participation among women who do not participate regularly in cervical cancer screening.

Objectives:

* To evaluate the effectiveness of two experimental invitation strategies (urine or vaginal self-sampling) to reach under-screened populations and compare them to the current invitation strategy in rural departments in France.
* To improve the response rate among women aged 30 to 65 years (not screened over a period longer than the recommended screening interval) who did not respond to a conventional prior invitation.

Trial design:

1:1:1 randomised population-based participation trial, with 2 experimental and 1 control arm, with in each arm a 1:1 sub-randomisation with subgroup A receiving a questionnaire and subgroup B receiving no questionnaire.

The study is a randomised controlled trial with three arms: a control arm (conventional invitation letter) and two experimental arms (mailing of a urine or vaginal self-sampling kit).

Efficacy of Strategies Involving Self-sampling to Reach Women Not Participating in Regular Cervical Cancer Screening

A Randomised Controlled Trial Assessing the Efficacy of Strategies Involving Self-sampling to Reach Women Not Participating in Regular Cervical Cancer Screening

(number of responding / number of invited)

(number of responding / number of invited). Contrast in participation between the 2 experimental arms

(number of responding / number of invited). Contrast in participation between women that received a questionnaire or not

Virological result. presence of high-risk HPV

gynecological follow-up (cytological results)

reimbursement status (benefit or not from supplementary universal health care coverage)

geographical area (including the deprivation index corresponding with the statistical sector where the woman is domiciled)

geographical area (geographical area (including the deprivation index corresponding with the statistical sector where the woman is domiciled)

thematic analysis integrating a specific focus on the indicators identified in previous studies (e.g. lack of time, discomfort with regard to the location or bad experience encountered during another type of examination, etc.).

categorical analysis based on Linguistic Inquiry and Word count which allows, among other things, to automatically categorise positive or negative emotions related to themes for example associated with the disease or beliefs

National Cancer Institute, France

Sciensano

University Hospital, Angers

University of Angers

Centre Regional de Coordination des Depistages des Cancer - Pays de la Loire

Respiratory Tract (Lung and Bronchial) Diseases

Immune System Diseases

Rare Diseases

Lung Neoplasms

Hypersensitivity

Lung Diseases

Lung Diseases, Obstructive

Pulmonary Disease, Chronic Obstructive

Respiratory Tract Neoplasms

Thoracic Neoplasms

Respiratory Tract Diseases

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

breath samples of patients with confirmed lung cancer

patients with underlying lung disease and impairment in lung function

healthy individual with no lung disease and no history of cancer including lung cancer

breath sample is presented to sniffer dog in test tube

exhalation analysis of breath sample

Thorsten Walles, MD

Some groups reported that sniffer dogs can be applied to detect lung cancer in the exhaled breath of patients. Therefore, breath samples (BS) of patients are collected. Five sniffer dogs are trained to distinguish between the BS of patients with lung cancer and healthy individuals (controls). In a prospective, randomized blinded study the dog's ability to differentiate between BS of i) patients with lung cancer, ii) patients with inflammatory airway disease, but no evidence of cancer and iii) healthy individuals is tested.

All breath samples (BS) are collected in patients on the basis of radiologic findings before any intervention (bronchoscopy, biopsy or surgery) has been performed. The allocation to study groups is made following diagnostic work up and surgery.

Three study groups are defined using the following inclusion and exclusion criteria:

* lung cancer: male \& female, age 18-80, competent, confirmed lung cancer in diagnostic work up and surgery, no history or present other tumor disease
* healthy individual: male \& female, age 18-80, competent, no history or present other tumor disease including lung cancer, no pathological lung function tests
* chronic obstructive lung disease: male \& female, age 18-80, competent, no history or present other tumor disease including lung cancer, pathological lung function tests

For each patient, i) history, ii) present medication, iii) lung function tests are documented. For the lung cancer patients, the tumor stage following surgery is documented.

Five sniffer dogs are trained using BS of lung cancer patients and healthy individuals. After completion of the training the ability of the dogs to differentiate between the groups is tested:

* 5 BS are presented in 1 experiment:

  * Test I: lung cancer vs healthy individual
  * Test II: lung cancer vs chronic obstructive pulmonary disease
  * Test III: lung cancer vs healthy individuals \& bronchitis
* for every experiment 1 BS of a lung cancer patient is used

  * the lung cancer sample is placed randomly in one of the five test tubes
  * the other test tubes are used for BS of healthy individuals or chronic obstructive pulmonary disease patients or both
  * neither the dog handler nor the dog know the loading of the test tubes
* experiments are repeated 5 to 10 times

For analysis, the sensitivity and specificity of the dog's reaction is determined.

The patient's medication, smoking habits, age and gender are analysed to rule out confounders or bias.

Early Detection of Lung Tumors by Sniffer Dogs - Evaluation of Sensitivity and Specificity

Prospective Clinical Study to Determine the Predictive Value of Sniffer Dogs to Identify Lung Cancer in the Exhalation of Patients With and Without Pulmonary Disease

number of individuals in the study cohort with confirmed lung cancer whose exhalation sample is correctly identified by sniffer dogs to contain an heretofore unknown substrate that is associated with lung cancer

number of individuals with confirmed impairment of lung function but exclusion of lung cancer whose exhalation sample is wrongly identified by sniffer dogs to contain a heretofore unknown substrate that is associated with lung cancer

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Breast Cancer Screening With MRI in Women Aged 50-75 Years With Extremely Dense Breast Tissue: the DENSE Trial	NCT01315015	Breast Cancer	Contrast enhanc...	50 Years - 75 Years	UMC Utrecht
Efficacy of Strategies Involving Self-sampling to Reach Women Not Participating in Regular Cervical Cancer Screening	NCT05243888	Cancer Screenin...	self-sampling	30 Years - 65 Years	Centre Regional de Coordination des Depistages des Cancer - Pays de la Loire
Early Detection of Lung Tumors by Sniffer Dogs - Evaluation of Sensitivity and Specificity	NCT01141842	Lung Cancer Chronic Obstruc...	exhalation anal... exhalation anal... exhalation anal...	18 Years - 80 Years	Schillerhoehe Hospital

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