Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Anti-Infective Agents

All Drugs and Chemicals

Formaldehyde

Women with Breast Cancer

The purpose of the study is the identification and semi-quantification of Ki-67 protein expression level in breast cancer tissues by the GenASIs GoPth system as compared to manual reading of the same slides.

The imaging system is intended for diagnostic use as an aid to the pathologist in the detection, counting and classifying ER/PR IHC stained samples

The anti Ki-67 is a semi-quantitative immunohistochemical (IHC) assay to identify the Ki-67 protein expressions in formalin-fixed, paraffin-embedded human breast cancer tissue specimens. Results from the Ki-67 test is indicated as an aid in the assessment of the protein status of breast cancer patients. While the p53 kit provides the antibody that offer direct visualization and semi-quantification of the protein expression through a brightfield microscope, the GenASIs GoPath system is designed to complement the routine workflow of the pathologist in the analysis and review of immunohistochemically stained histologic slides.

Identification and Semi-Quantification of Ki-67 Protein Expression Status

Identification and Semi-Quantification of Ki-67 Protein Expression Status in Formalin Fixed, Paraffin-embedded Normal and Neoplastic Breast Tissue

Comparison tests (accuracy) between manual and automatic analysis of antibody expressions. The results from the automatic counting from the clinical studies will be compared to the manual counting analysis.

Accuracy of the study will be declared "Success" if Positive, Negative and Overall agreement with manual count of the Ki67 antibody at least 85%.

Repeatability \& Reproducibility tests of system analysis of antibody expressions. R\&R acceptance criteria of Ki67 are related to the average agreement for between runs, between days and between systems R\&R part of the study will be declared "Success" if Positive and Negative average agreement will be at least 80%.

Applied Spectral Imaging Ltd.

Antihypertensive Agents

Perindopril

Bisoprolol

Sympatholytics

Adrenergic Agents

Adrenergic beta-1 Receptor Antagonists

Adrenergic beta-Antagonists

Adrenergic Antagonists

Neurotransmitter Agents

Enzyme Inhibitors

Angiotensin-Converting Enzyme Inhibitors

HIV Protease Inhibitors

Protease Inhibitors

women with breast cancer, with a morphologically confirmed diagnosis before the appointment of anticancer therapy, untreated

women with breast cancer, with a morphologically confirmed diagnosis before the appointment of anticancer therapy, receiving treatment with a combination of bisoprolol and perindopril

based on the results of the patient study, different drug therapy regimens for cardiovascular complications during chemotherapy will be proposed

Bisoprolol; Perindopril;

To develop a method of medical prevention of cardiovascular diseases caused by cardiotoxicity against the background of complex treatment of patients with primary resectable breast cancer to reduce the risk of cardiovascular complications

Purpose of the study: to develop a method of medical prevention of cardiovascular diseases caused by cardiotoxicity against the background of complex treatment of patients with primary resectable breast cancer to reduce the risk of cardiovascular complications

Prevention of Cardiovascular Diseases Caused by Complex Treatment of Patients With Primary Operated Breast Cancer

To Develop and Implement a Method for Medical Prevention of Cardiovascular Diseases Caused by Complex Treatment of Patients With Primary Operated Breast Cancer

hypertension, cardiomyopathy, arrhythmia's, myocardial infarction, heart failure

State Institution "Republican Scientific and Practical Center" Cardiology, Belarus

Researcher, Hypertension Laboratory Republican Scientific and Clinical Cardiology Center Republic of Belarus, Belarus

Wounds and Injuries

Dermatitis

Radiodermatitis

Two of four regions of the breast will be randomly chosen to receive 3M Cavilon No Sting Barrier Film treatment twice per week.

Half the breast will receive 3M Cavilon No Sting Barrier Film and one half will receive standard skin care

3M Cavilon No Sting Barrier Film

Standard Preparation

Michael Lock, MD, FRCPC

To evaluate the effectiveness of preventing Grade II or greater radiation dermatitis induced by adjuvant radiation therapy in women with breast cancer.

Rationale

Radiation dermatitis is a common problem in a significant proportion of breast cancer patients. In addition, radiation dermatitis is a quantifiable complication which is relatively easily observed and graded according to modified Radiation Therapy Oncology Group (RTOG) criteria for toxicity. Radiation dermatitis is thought to be related to abrasion that degrades the keratinized skin surface. This results in decreased ability of skin stem cells to regenerate which leads to moist desquamation. A barrier film could potentially form a protective scaffold for new skin growth and repair. Cavilon No Sting Barrier Film (BF) has been shown in randomized trials involving post-mastectomy radiation patients to reduce the duration and frequency of radiation-induced moist desquamation. However, this treatment has not been studied in the statistically more prevalent situation of an intact breast. Therefore, we propose to investigate Cavilon to reduce side-effects of radiation treatment in intact breast cancer patients treated with conservative surgery and adjuvant radiation therapy.

2.0 STUDY OBJECTIVES 2.1 Primary Objectives To evaluate effectiveness of preventing Grade II or greater radiation dermatitis induced by adjuvant radiation therapy in women with breast cancer. The grading of dermatitis will be obtained according to modified RTOG scale for visual assessment of radiation-induced skin erythema. This is attached as Appendix A. In addition, Skin Toxicity Assessment Tool (STAT) will also be used by the patient and physician validated against the quality of life tools and toxicity tools. This is attached as Appendix B.

2.2 Secondary Objectives Quality of Life The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) will be used to measure overall quality of life. Quality of life has been considered an important contributor to overall performance status and outcome. Quality of life consists of multiple components (e.g. physical, social, and psychological aspects, etc.). Improved quality of life translates into better outcomes, especially in the context of palliation. Global quality of life was found to be significantly associated with survival in a general population of cancer patients in Canada . In fact, many clinical trials in palliative care include improved quality of life for cancer patients as a primary outcome. The EORTC Quality of Life Questionnaire (QLQ-C30) was developed in Europe and is frequently used to measure quality of life and its related components . The EORTC QLQ C-30 is attached in appendix C.

Time to develop radiation dermatitis On each follow up visit, all patients will be assessed for development of any grade of radiation dermatitis. The time to develop grade I, II and or grade III radiation dermatitis will be calculated from the date of first dose of radiation therapy delivered to the date of visit at which the grade of dermatitis is observed. Time to additional treatment, i.e. over-the-counter or prescription interventions, will also be measured.

Image An observer, blind to the regions treated by Cavilon, will also grade each paired photographic image.

Qualitative Questions Qualitative questions are meant to ask personal opinion and perspectives. The answers provide further insight into the related issue or question. We have designed a very simple approach with 2-3 open-ended questions for both patient and practitioner. See Appendix D.

3.0 OVERALL STUDY DESIGN AND PLAN 3.1 Study Design Randomized paired comparison design, conducted at a single centre, the London Regional Cancer Program (LRCP), Ontario, Canada. A total of 47 patients will be accrued for this study. Eligible patients will be contacted and study details will be reviewed with them. The schedule for BF will be two times per week throughout the duration of radiation therapy. Each BF treatment will be applied immediately before radiation treatment by the radiation therapist using a film template. The template is a cellophane sheet with two quadrants physically removed. The quadrants removed will be randomly selected to receive the film spray treatment. The template is used only at the time of BF application. Other quadrants may receive standard treatment. No placebos will be used. To ensure the template is placed at the correct location for each treatment, localization will use the permanent tattoos used for radiation treatment localization. This is an intention-to-treat trial.

3.1.1 Baseline/Accrual (Visit 1)

Patients with a histopathologically or cytologically confirmed diagnosis of breast cancer scheduled to receive adjuvant radiation therapy may be screened. The following procedures/assessments will take place during this visit for the patient:

* Obtaining written informed consent
* Reviewing inclusion/exclusion criteria
* Obtaining disease history, including date of first diagnosis, and the history of the course of the patient's histopathologically or cytologically confirmed diagnosis of breast cancer, and information about prior radiation or chemotherapy
* Obtaining medical history (past or concurrent clinically significant disease(s))
* Obtaining demographic data including history of radiation sensitivity or radiation sensitizers
* Obtaining information about any planned treatment
* Perform a general physical examination
* A patient who meets all eligibility criteria will be enrolled in the study and the following additional procedures will be performed:
* Completion of questionnaire for STAT, modified RTOG visual assessment of erythema, qualitative questionnaire and QLQ-C30
* Assign two of four regions by random number list

3.1.2 Treatment Phase (Weekly assessment)

After the Baseline visit, patients will return to the study site for scheduled follow-up visits, also called Patient Review (PR). The following procedures/assessments will be performed during these visits:

* Evaluation and documentation of any grade radiation dermatitis using STAT and the modified RTOG erythema scale
* Documentation of any new medication use including use of skin creams

3.1.3 Follow-up Visit (One week post treatment completion)

The following procedures/assessments will be performed during the follow-up visit:

* Evaluation and documentation of any grade radiation dermatitis
* Completion of questionnaire for QLQ-C30
* Completion of qualitative questions
* Completion of global questionnaire

4.0 SELECTION OF STUDY POPULATION

The study will be conducted in patients with histopathologically or cytologically confirmed diagnosis of breast cancer, scheduled to receive adjuvant radiation therapy as outpatients at the London Health Sciences Centre, London, Ontario.

5.0 STATISTICAL EVALUATION 5.1 Determination of Sample Size The primary endpoint will be a comparison of region 1 (region treated with standard care) and region 2 (region treated with BF). Based on the same endpoint measure, we estimate the baseline/standard care risk of grade 2 toxicity and higher to be approximately 60% at any point during the assessment period. Studies with the same and similar products demonstrate an expected reduction of grade 2 or higher toxicity to approximately 30%. This is also a clinically important significant difference . The sample size required is 42 (paired analysis). This assumes a Type I error of 0.05 and a power of 80% to reject the null hypothesis. With an expected 5% excess added due to loss to follow up or non-evaluable data, we would require a sample size of 47 patients. This is consistent with landmark Uppsala randomized study demonstrating the value of corticosteroid cream with 42 patients.

5.2 Statistical Analysis SAS (SAS Institute, Cary, NC) was used to generate a random allocation list with two stratification blocks (i. chemo no chemo; ii. breast separation).The physician will be unaware of the treatment allocation, but the patient and radiation therapist administering the film will not be blinded. For qualitative measures, McNemar's (McNemar) chi-square test for paired proportions will be used. For quantitative measures, a paired t-test or a signed rank test will be used. For the 'time to event' variables that will be paired, Kaplan Meier estimates to graphically demonstrate the 'time to event' will be used. The statistical comparisons will be performed using proportional hazards models with a sandwich estimator to account for the pairing with a sandwich estimator. A repeated measures ANOVA will be used to assess the four quadrants. If the data is poorly distributed then we will take a median of the two treated areas and two control areas and apply a singed rank test. Note that this is not the principle endpoint of the trial. The principle endpoint of the trial is a 1-to-1 comparison of the BF treated area and the area treated using standard options. A multivariable analysis will be performed to determine factors impacting on skin toxicity. The multivariable analysis will not be used for between patient comparisons as differences will be accounted for by the pairing. All significant tests will be two-sided and performed at the 5% level.

within patient randomization of Cavilon skin spray

within patient randomization. One half of breast received Cavilon and other receives standard of care treatment. Care provider is blinded as to portion receiving treatment.

Barrier Film vs. Standard Skin Care in Preventing Dermatitis in Women With Breast Cancer Receiving Radiation

Phase III Randomized Pair Comparison of a Barrier Film vs. Standard Skin Care in Preventing Radiation Dermatitis in Women With Breast Cancer Receiving Adjuvant Radiation Therapy

Release as requested and via publication access notification

cost will be measured in Canadian dollars. The cost of standard care will be assessed by direct patient questioning on what was purchased. The cost of the Cavilon is standard for all patients (currently $28)

Lawson Health Research Institute

Principal Investigator

women who receives mammography because of suspected breast lesion(s)

When a woman comes to the clinic to receive mammography. Then a radiologist will give a BI-RADS classification after reviewing the images. If a BI-RADS 4/5 is obtained, the woman will receive pathological biopsy to ensure there is a benign or malignant lesion. If a BI-RADS 3 is obtained, the woman will be followed up by a half-year interval until two year after the first mammography. At each follow up, she will receive mammography. If a BI-RADS 4/5 is obtained at follow up, she will receive pathological biopsy; if a BI-RADS 1/2/3 is obtained at follow up, she will be followed up by a half-year interval until two year. If a BI-RADS 1/2 is obtained at the first mammography, the woman will receive a second mammography after two year. During the study period, breast examination and results will be recorded for every subject. Radiologists will give the diagnosis with and without AI support.

mammography

Ying-Shi Sun, Professor

This project aims to establish a comprehensive artificial intelligence system for detecting and qualitative diagnosing breast lesions. Mammary images will be used to construct a diagnosis method based on deep learning. The system is proposed to automatically analyze the type of mammary glands, automatically identify and mark all breast lesions on the mammography images, provide the malignancy probability judgment of the lesions, the BI-RADS classification and the clinical suggestion, and also automatically generate the structured diagnosis report.

This is a multi-center study.The project contains a retrospective part(3000 samples anticipated) and a prospective part(7000 samples anticipated). In the retrospective part, investigators collected subjects with mammary images to design the deep learning method and construct a detective and diagnostic model for breast lesions. In the prospective part, investigators validate the accuracy of the constructed deep learning method, and established artificial intelligence system focusing on mammary diagnosis. Investigators will also explore the application pattern of the artificial intelligence system in clinical practice.

If a subject is diagnosed with BI-RAD4/5, she will receive pathological biopsy. The tissue sample from biopsy will be used to give a definitive malignant or benign diagnosis.

Development of Artificial Intelligence System for Detection and Diagnosis of Breast Lesion Using Mammography

the accuracy of the AI model, radiogist with AI support, radiologist alone for binary diagnosis of a benign or malignant breast lesion according to pathology. If either one mammography of BI-RADS 4/5 in the first examination or during the two year' follow up examination is obtained,a pathological examination is performed, the lesion is judged benign or malignant according to pathological results.

the accuracy of the AI model, radiogist with AI support, radiologist alone for binary diagnosis of a benign or malignant breast lesion according to follow up. If a 2-year mammography of BI-RADS 1/2/3 is obtained, the lesion is considered benign. If either one mammography of BI-RADS 4/5 during the two year is obtained,a pathological examination is performed to ensure the benign or malignant lesion

the detection rate of the constructed deep learning method for detecting benign or malignant breast lesion according to radiologist's subjective diagnosis or follow up as reference. If a radiologist suggests existence of a lesion at the first mammography or at each follow-up mammography during the 2-year period, it is considered that a lesion exists

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Identification and Semi-Quantification of Ki-67 Protein Expression Status	NCT02654457	Breast Cancer	Women with Brea...	21 Years - 89 Years	Applied Spectral Imaging Ltd.
Prevention of Cardiovascular Diseases Caused by Complex Treatment of Patients With Primary Operated Breast Cancer	NCT04588935	Women With Brea...	Bisoprolol; Per...	-	State Institution "Republican Scientific and Practical Center" Cardiology, Belarus
Prevention of Cardiovascular Diseases Caused by Complex Treatment of Patients With Primary Operated Breast Cancer	NCT04588935	Women With Brea...	Bisoprolol; Per...	-	State Institution "Republican Scientific and Practical Center" Cardiology, Belarus
Barrier Film vs. Standard Skin Care in Preventing Dermatitis in Women With Breast Cancer Receiving Radiation	NCT01762020	Breast Cancer Dermatitis	3M Cavilon No S... Standard Prepar...	18 Years - 80 Years	Lawson Health Research Institute
Identification and Semi-Quantification of Ki-67 Protein Expression Status	NCT02654457	Breast Cancer	Women with Brea...	21 Years - 89 Years	Applied Spectral Imaging Ltd.
Development of Artificial Intelligence System for Detection and Diagnosis of Breast Lesion Using Mammography	NCT03708978	Women With Brea...	mammography	18 Years -	Peking University Cancer Hospital & Institute

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