Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Urinary Bladder Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

We propose to conduct a pilot study among 30 volunteers from the Division of Cancer Epidemiology and Genetics (DCEG) in order to: (1) select the urine pH strip that most closely correlates with urine pH measured by pH meter for the New England Bladder Cancer Study, (2) calibrate the urine pH strip that was used for the Spanish Bladder Cancer Study against pH measured by a pH meter, and (3) compare the DNA yields from buccal cells obtained from two different methods: mouthwash vs toothbrush-rinse method. Information collected from this pilot study will be used to select and optimize the sample collection protocols in the New England Bladder Cancer Study. At the time of enrollment, study participants will be asked to provide information on age, gender, height, weight, consumption of antacids and calcium supplements, and whether they ate, drank or brushed their teeth in the last hour previous to the buccal cells ample collection. In addition, they will have to measure their urine pH with four different pH strips twice a day (early morning and before dinner) for a week and record the measurements in a diary. During the same week, they will be asked to collect two spot urine samples each day from Monday to Thursday (early morning and before dinner), and one more on Friday morning, and bring them into work in a cooler. Also, they will be asked to collect a continuous 24-hour urine sample during one of the three first days of the week. Urine samples will e picked up by lab personnel from BioReliance, and pH will be measured at their laboratory with the four pH strips again and with a pH meter. Buccal cells sample collection will be completed during the first and the last day of the urine sample collection period. The first day, study participants will be asked to provide a water rinse sample after brushing the inside of their cheeks with a toothbrush, and a week later they will be asked to provide a mouth wash sample consisting of two consecutive rinses with Scope mouthwash. All samples and questionnaire data will be unlinked from personal identifiers after the sample collection is completed. Participants will be compensated with $100 for the inconvenience of participating in this complex study and for their time.

We conducted a pilot study among 30 volunteers from the Division of Cancer Epidemiology and Genetics (DCEG) in order to: (1) select the urine pH strip that most closely correlates with urine pH measured by pH meter for the New England Bladder Cancer Study, (2) calibrate the urine pH strip that was used for the Spanish Bladder Cancer Study against pH measured by a pH meter, and (3) compare the DNA yields from buccal cells obtained from two different methods: mouthwash vs toothbrush-rinse method. At the time of enrollment, study participants were asked to provide information on age, gender, height, weight, consumption of antacids and calcium supplements, and whether they ate, drank or brushed their teeth in the last hour previous to the buccal cells sample collection. In addition, they measured their urine pH with four different pH strips twice a day (early morning and before dinner) for a week and record the measurements in a diary. During the same week, they were asked to collect two spot urine samples each day from Monday to Thursday (early morning and before dinner), and one more on Friday morning, and bring them into work in a cooler. Also, they were asked to collect a continuous 24-hour urine sample during one of the three first days of the week. Urine samples were picked up by lab personnel from BioReliance, and pH was measured at their laboratory with the four pH strips again and with a pH meter. Buccal cells sample collection was completed during the first and the last day of the urine sample collection period. The first day, study participants were asked to provide a water rinse sample after brushing the inside of their cheeks with a toothbrush, and a week later they were asked to provide a mouth wash sample consisting of two consecutive rinses with Scope mouthwash. All samples and questionnaire data was unlinked from personal identifiers after the sample collection was completed. Participants were compensated with $100 for the inconvenience of participating in this complex study and for their time. Information collected from this pilot study has been used to prepare manuscripts, as well as select and optimize the sample collection protocols in the New England Bladder Cancer Study.

Calibration of Urine pH Strips for NCI Case-Control Studies on Bladder Cancer and Comparison of DNA Yields From Buccal Cells Collected Through Two Different Methods

National Cancer Institute (NCI)

Digestive System Diseases

Rare Diseases

Stomach Neoplasms

Esophageal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Head and Neck Neoplasms

Esophageal Diseases

Stomach Cancer

Esophageal Cancer

No intervention will be provided to the subject

Bok Yan, Jimmy So

Jimmy So, MBChB

Clinical Decision Support Systems (CDSSs) to augment clinical care and decision making. These are platforms which aim to improve healthcare delivery by enhancing medical decisions with targeted clinical knowledge, patient information, and other health information.

In view of the benefit of developing a CDSS, we sought to develop an alternative CDSS for oncologic therapy selection through a partnership with Ping An Technology (Shenzhen, China), beginning with gastric and oesophagal cancer. This would be done in a piecemeal fashion, with the prototype platform utilizing only international guidelines and high-quality published evidence from journals to arrive at case-specific treatment recommendations. This platform would then be evaluated by comparing its recommendations with that from the multidisciplinary tumour boards of several tertiary care institutions to determine the concordance rate.

Management of cancer is a complex process which involves numerous stakeholders. In view of this, institutions worldwide have adopted the use of Multidisciplinary Tumor Boards (MTBs) for delivery of cancer care. By tapping on the collective specialized knowledge and experience of various specialties, MTBs have been shown in some studies to result in more appropriate recommendations and improved patient outcomes. At our institution, cancer cases are similarly discussed at regular MTBs which comprises surgeons, oncologists, pathologists and radiologists who review and recommend treatments.

However, in smaller centres or centres with limited resources and minimal multi-disciplinary expertise, delivery of timely and appropriate cancer care could be a challenge. Additionally, clinicians, with their busy schedule, may not be able to keep abreast of new developments in cancer research. With rapid advances in scientific research, this pool of knowledge is expected to continue to burgeon, making keeping up-to-date increasingly onerous.

To address this need, clinicians have adopted the use of Clinical Decision Support Systems (CDSSs) to augment clinical care and decision-making. These are platforms which aim to improve healthcare delivery by enhancing medical decisions with targeted clinical knowledge, patient information, and other health information. Various studies have shown CDSSs to be beneficial in selected settings such as patient safety and diagnosis \[4\], and to even increase adherence to clinical guidelines. In recent years, advancements in artificial intelligence have also seen its use expand to include oncologic therapy selection, with IBM's Watson for Oncology (WFO) being the most prominent and only platform in use to-date. In a 2018 study, WFO's ability to provide treatment advice for breast cancer was compared against recommendations from a multidisciplinary board, where it showed a high degree of concordance. Since then, several other studies have sought to examine WFO's ability to provide treatment recommendations for cancer such as ovarian, gastric, lung, cervical and colorectal cancers, with mixed results. In particular, both studies which examined the recommendations for gastric cancers showed a much lower concordance rate compared to other cancers.

In view of the above, we sought to develop an alternative CDSS for oncologic therapy selection through partnership with Ping An Technology (Shenzhen, China), beginning with gastric and esophageal cancer. This would be done in a piecemeal fashion, with the prototype platform utilizing only international guidelines and high-quality published evidence from journals to arrive at case-specific treatment recommendations. This platform would then be evaluated retrospectively and prospectively by comparing its recommendations with that from the multidisciplinary tumor boards of several tertiary care institutions to determine the concordance rate.

Development of a Clinical Decision Support System With Artificial Intelligence for Cancer Care

Comparative agreement in recommendations between the two study groups, as measured by concordance rate

To identify the reason for the discordance

National University Hospital, Singapore

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Breast Neoplasms

Neoplastic Cells, Circulating

Breast Diseases

Skin Diseases

Investigators plan to enroll patients who are undergoing biopsy for potential metastatic Breast Cancer any subtype ER/PgR+ and HER2, triple negative or HER2+ at least 6 months before suspected metastases were identified. The suspected metastases in these patients must be outside the ipsilateral breast, axilla infra/supraclavicular areas. In those with suspected metastases in contralateral axilla, infra/supraclavicular areas only a new contralateral breast primary must be excluded by physical exam, mammogram and MRI

Blood will be drawn from each patient to check the concordance between liquid and tissue biopsy

Blood Draw

Robin Sachdeva, PhD

Lucas Mendez, MD, PhD

Ana Lohmann, MD, PhD

Tissue biopsy is a procedure to remove a piece of tissue (sample of cells) from the body to be analyzed in a laboratory, and it is commonly performed to confirm diagnosis of a patient with symptoms of breast cancer recurrence. It may also provide information on tumor markers (hormone receptors, HER2) that can guide treatment decisions. The goal of this study is to determine whether blood tests (which require less-invasive procedures) can be used to confirm diagnosis of suspected recurrent breast cancer (as compared to tissue biopsy).

Investigators plan to investigate blood factors which include circulating tumor cells (CTCs - i.e., cancer cells that can be detected in the blood), circulating tumor DNA (ctDNA - i.e., pieces of DNA from cancer cells that can be found in the blood), as well as other biomarkers. Investigators will conduct this study in 120 participants who present with suspected breast cancer recurrence and symptoms of cancer that has spread to other areas in the body.

Participants will be asked for blood collection within 30 days before tissue biopsy. The tissue will be analysed locally to determine the presence of cancer and the tumor markers listed above. The blood will be processed and stored for analysis of CTCs and ctDNA. If these blood tests show concordance with tissue based tests (presence of cancer cells, hormone receptors \& HER2 status), these tests could be used in future studies to confirm diagnosis using a non-invasive procedure. Also, investigators believe that the results of this study can influence other research of early-stage recurrent breast cancer.

In Canada, it is estimated that more than 26,900 women will be diagnosed with breast cancer (BC), and 5,000 women will die from BC in 2019. Metastatic BC will cause the vast majority of these deaths. Tissue biopsy is recommended to confirm recurrence (presence of cancer cells) in patients with a history of previous BC. Additionally, tissue biopsy provides information on BC subtypes (estrogen receptor (ER), progesterone receptor (PgR), and HER2 status). Technological advances over the last several years have led to more robust methods for the detection, quantification, and characterization of liquid biopsy (including CTCs and ctDNA) in recurrent BC. If these approaches demonstrate sufficiently concordant results to tissue-based testing, blood draws may quickly become a viable alternative to invasive biopsies.

In a cross-sectional study, 120 consecutive individuals from study centers in Ontario, who present with highly suspicious BC distant metastases who undergo biopsy to confirm BC recurrence will be enrolled (enrollment will be continued until 100 subjects with confirmed metastatic breast cancer have been enrolled). Blood samples for the circulating factors will be taken within 30 days prior to the tissue biopsy. Patient and tumor characteristics will be recorded. At the end of study, liquid biopsy (CTCs and ctDNA) analyses will be performed blinded to biopsy results. Investigators will continuously review the number of participants in each BC subtype. Cases with tissue biopsy results not classified as definite or highly suspicious for metastatic breast cancer by the treating physician will be re-assessed after six month of study entry in an attempt to classify them as having metastatic breast cancer or not. This aims to confirm/rule out breast cancer or other diagnosis.

The overall anticipated public and/or scientific benefit of the study is to demonstrate the concordance between liquid (blood) biopsy and tissue based tests in terms of the presence of cancer cells, hormone receptors, HER2 status etc. so these tests could be used in the future to confirm diagnosis using a non-invasive procedure. The results of this study will advance our understanding of liquid biomarkers and ideally improve the care journey for breast cancer patients by not subjecting them to invasive and potentially dangerous biopsy procedures.

Concordance Between Liquid and Tissue Biopsy

Concordance Between Liquid and Tissue Biopsy in Newly Diagnosed Metastatic Breast Cancer

To analyze concordance between liquid biopsy, CTCs (Epic Sciences) and ctDNA (academic assays based on mutations and/or epigenetic changes), with biopsy results (presence or absence of cancer), and with all blood assays being conducted blinded to tissue biopsy results

To conduct secondary analyses of the concordance between hormone receptor and HER2 status identified on tissue specimens with those identified on CTCs (Epic Sciences).

To classify tissue biopsy results according to the interpretation of the local pathologist, the treating physician (primary comparator) and the study investigators (interpretations to include clinical data such as physical exam, radiologic investigations, blood work as available).

To conduct exploratory analyses of the associations between tumor markers and CTCs or ctDNA.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Calibration of Urine pH Strips for NCI Case-Control Studies on Bladder Cancer and Comparison of DNA Yields From Buccal Cells Collected Through Two Different Methods	NCT00339443	Calibration		-	National Institutes of Health Clinical Center (CC)
Development of a Clinical Decision Support System With Artificial Intelligence for Cancer Care	NCT04675138	Gastric Cancer Esophageal Canc... Esophagogastric...	No intervention...	21 Years -	National University Hospital, Singapore
Calibration of Urine pH Strips for NCI Case-Control Studies on Bladder Cancer and Comparison of DNA Yields From Buccal Cells Collected Through Two Different Methods	NCT00339443	Calibration		-	National Institutes of Health Clinical Center (CC)
Concordance Between Liquid and Tissue Biopsy	NCT04241237	Breast Neoplasm...	Blood Draw	18 Years -	Lawson Health Research Institute
Development of a Clinical Decision Support System With Artificial Intelligence for Cancer Care	NCT04675138	Gastric Cancer Esophageal Canc... Esophagogastric...	No intervention...	21 Years -	National University Hospital, Singapore
Development of a Clinical Decision Support System With Artificial Intelligence for Cancer Care	NCT04675138	Gastric Cancer Esophageal Canc... Esophagogastric...	No intervention...	21 Years -	National University Hospital, Singapore

Spots Global Cancer Trial Database for concordance

Every month we try and update this database with for concordance cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for concordance

Every month we try and update this database with for concordance cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for concordance cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.