Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Arif Awan, MD

A broad range of prognostic and predictive tools are available for patients with newly diagnosed early stage breast cancer. These range from free and publicly available mathematical algorithms, through to expensive genomic tests. It is not known how the use of these different scores affects physician decision making with respect to ordering genomic tests, nor how well these algorithms predict for the results of Oncotype DX ® in the real-world setting. This pragmatic study will help to answer these questions.

A broad range of prognostic and predictive tools are available for patients with newly diagnosed early stage hormone receptor positive, Her2 negative breast cancer. These range from free and publicly available mathematical algorithms (e.g. NHS Predict, Magee formulae, Gage and Tennessee equations) that incorporate standard pathology results, through to expensive genomic tests (e.g. Oncotype DX ® and Endopredict ®). It is not known how the use of these different scores affects physician decision making with respect to ordering genomic tests, nor how well these algorithms predict for the results of Oncotype DX ® in the real-world setting. This pragmatic study will help to answer these questions.

In summary: Month 1 to 3: pathology and chemotherapy data is collected, no physician questionnaires given. Month 4 to 6: pathology and chemotherapy data collected, plus physician questionnaire administered. Intervention teaching after 6 months of study activation. Month 7 to 9: pathology and chemotherapy data collected, PREDICT 2.1 tool used, no physician questionnaire given. Month 10 to 12: pathology and chemotherapy data collected, PREDICT 2.1 tool used, plus physician questionnaire administered.

Evaluating Whether Integration of Prognostic and Predictive Algorithms Into Routine Clinical Practice Effect Whether Oncologists Order Multigene Assays in Patients With Early Stage Breast Cancer

A Multi-centre, Prospective, Observational Study Evaluating Whether Integration of Prognostic and Predictive Algorithms Into Routine Clinical Practice Effect Whether Oncologists Order Multigene Assays in Patients With Early Stage Breast Cancer

To assess whether providing individual patient prognostic and predictive scores from PREDICT 2.1 affects the rate of subsequent requests for Oncotype DX ® testing. This will be the proportion of patients for which Oncotype DX ® is ordered, defined as the number of patients with Oncotype DX ® ordered divided by the number of patients eligible for Oncotype DX ® testing.

To assess whether routine availability of PREDICT 2.1 affects adjuvant treatment (chemotherapy, radiation therapy and endocrine therapy). This will be done by identifying the time to starting chemotherapy, endocrine therapy or radiation therapy.

Prognostic risk scores, including Magee formulae, Gage and Tennessee equations will be calculated using patient and tumour characteristics. These scores will be compared with Oncotype DX ® scores when performed. These will be used to determine Oncotype DX ® cost and total health system costs and subsequent health care utilization.

A physician survey will be used to assess physician comfort when making systemic therapy decisions.It will determine whether the routine availability of PREDICT 2.1 score in the clinic enhanced their comfort with systemic therapy decision-making.

Ottawa Hospital Research Institute

Women and men with node negative, ER positive breast cancer who are receiving (or will receive) endocrine therapy, and who are candidates for chemotherapy.

Gene signature test containing 21 genes (16 cancer-related genes, e.g., invasion, proliferation, ER, Her 2 and five reference genes) and generates an individualized recurrence score.

ONCOTYPEDX Test

Mark N. Levine, MD

A prospective population-based cohort study is being conducted in Ontario to evaluate whether the performance of Oncotype DX® changes the treatment recommended and the treatment received in women or men with node negative, ER positive breast cancer who are receiving (or will receive) endocrine therapy and who are candidates for chemotherapy. One thousand eligible consenting women and men will have their tumor tissue specimen sent to Genomic Health where the Oncotype DX® assay will be performed.

The evidence supporting the adoption of Oncotype DX® is relatively weak by the criteria used by the Ontario Health Technology Advisory Committee (OHTAC). There is only one small published prospective study that reports on Oncotype DX® changing clinical management. The economic models that estimated the potential advantages of using an Oncotype DX® guided treatment strategy may have overestimated the benefits because they assumed that all patients with tumors \>1cm in the absence of Oncotype DX® testing would receive chemotherapy in addition to tamoxifen, and that the magnitude of benefit with chemotherapy over tamoxifen is relatively large, i.e. reduces recurrence risk by 74% and associated with an absolute benefit of 28%. (The benefit comes from one trial and is applied to all patients). It is estimated that there are about 3,300 incident cases with node negative, ER positive, HER2 neu negative tumors annually in Ontario, it is important to evaluate the adoption of this test for decision making in Ontario.

A Prospective Cohort Study to Evaluate the Oncotype DX® Test in Early Stage Breast Cancer

The primary outcome is the change in treatment recommendation by the oncologist and the change in treatment preference of the patient.

The level of association between the Oncotype DX® RS with estimated recurrence risk calculated by Adjuvant! Online, as well as with traditional factors including tumor size, grade, and HER2 neu.

The change in the level of patient decisional conflict measured by the Decisional Conflict Scale (DCS). Additionally, the DCS has three subscales: uncertainty, effective decision making, and factors contributing to uncertainty. The change in each of these subscales will also be measured.

To determine the robustness of the economic model of sequential Adjuvant! Online followed by Oncotype DX®.

Ontario Ministry of Health and Long Term Care

Ontario Clinical Oncology Group (OCOG)

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

National Comprehensive Cancer Network (NCCN) counseling uses recommendations based on currently-accepted approaches to cancer treatment.

National Comprehensive Cancer Network (NCCN) counseling uses recommendations based on currently-accepted approaches to cancer treatment. The result provided by the Oncotype DX prostate test is called a Genomic Prostate Score (GPS). The GPS provides important information about how aggressive a man's cancer is based on the biology of the man's individual tumor.

Standard NCCN counseling

Standard NCCN counseling and Oncotype DX results

Peter H Gann, MD, ScD

Adam B Murphy, MD

This research is being done to better understand how a new lab test called the Oncotype DX Prostate Cancer Assay may impact what treatment men decide to get and how they feel and think about their choice of treatment. The study will compare men who receive this new lab test with men who receive the usual counseling given to men after they get a new diagnosis of prostate cancer. Prostate cancer is sometimes slow-growing and sometimes fast-growing. Healthcare providers are searching for better ways to predict how each tumor will behave so that each man can make a better decision about when to receive treatment. The Oncotype DX lab test uses leftover prostate biopsy tissue to generate a Genomic Prostate Score (GPS). The GPS is related to the risk of a fast-growing cancer being discovered if surgery is performed to remove a man's prostate. The goal of this study is to find out if this test helps men when they are deciding how their prostate cancer will be treated. Treatment options include surgery to remove the prostate, radiation therapy, or an approach called "active surveillance" in which there is no immediate therapy and the tumor is watched using prostate specific antigen (PSA) tests and repeat biopsies.

Engaging Newly Diagnosed Men About Cancer Treatment Options

The Impact of a Gene Expression Profile on Treatment Choice and Outcome Among Minority Men Newly Diagnosed With Prostate Cancer: A Randomized Trial

United States Department of Defense

Cook County Hospital

Genomic Health®, Inc.

University of Illinois at Chicago

Professor of Pathology

Symptoms and General Pathology

Recurrence

Bone Density Conservation Agents

Antineoplastic Agents

All Drugs and Chemicals

Tamoxifen

Estrogens

The Oncotype DX® assay is a multi-gene reverse-transcriptase-polymerase-chain-reaction (RT-PCR) test that analyzes the expression of 21 genes, and quantifies the 10 year distant breast cancer recurrence risk in patients with stage I and II, lymph node negative, estrogen receptor positive disease who plan to be treated with tamoxifen for 5 years.

Oncotype DX

Stephen Chia, MD

This study is a multi-center BCCA study that evaluates the impact of the Oncotype DX® assay on the decision making of the treating physician and the patient. The Oncotype DX® assay is a commercially available diagnostic test that aids in a physician's treatment recommendation to a breast cancer patient. The study also has a pharmacoeconomic component.

This study is a multi-center BCCA study that evaluates the impact of the Oncotype DX® assay on the decision making of the treating physician and the patient. The study also has a pharmacoeconomic component. All eligible patients in which either physician and/or patient determine that results from the 21 gene recurrence score could provide additional information useful in the decision making process regarding adjuvant chemotherapy or not will be asked by the participating physicians to participate in the study. If interested, the patient will consent to the study. The physician will complete a baseline questionnaire to document recommended adjuvant systemic therapies (pre-Oncotype DX®). The Oncotype DX® assay will be ordered after receipt of the Physician and Patient Registration and assignment of patient study number. The physician will discuss the results of the Oncotype DX® assay with the patient once the result is available and upon receipt of the pre-test questionnaire. The physician will complete a follow-up questionnaire (to document recommended adjuvant systemic therapies post Oncotype DX®) after the result of the Oncotype DX® assay is known.

(Oncotype DX®) in Estrogen Receptor Positive (ER+) HER-2 Negative (HER 2-) 1-3 Node Positive (pN1) Breast Cancer

A Prospective Clinical Utility Study of the Impact of the 21 Gene Recurrence Score® Assay (Oncotype DX®) in Estrogen Receptor Positive (ER+) HER-2 Negative (HER 2-) 1-3 Node Positive (pN1) Breast Cancer in Multiple BC Cancer Agency Centres

The Oncotype DX® assay affect on physician's treatment recommendations pre and post Oncotype DX® Recurrence Score® result.

Costs to a publicly funded health care system

British Columbia Cancer Agency

Nutritional and Metabolic Diseases

Carcinoma

Carcinoma in Situ

Carcinoma, Ductal

Calcinosis

Carcinoma, Intraductal, Noninfiltrating

Breast Carcinoma In Situ

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Patient with recently identified calcifications on mammography requiring biopsy. Patients will undergo a quantitative, multiparametric breast MRI as part of their clinical care. MRI will not change need for biopsy, but could identify additional suspicious sites. Only patients diagnosed with pure DCIS at biopsy and eventual surgical excision will receive Oncotype DX DCIS score testing.

Patient with recent diagnosis of biopsy-proven DCIS would complete a research quantitative, multiparametric breast MRI as part of their clinical care. Only patients diagnosed with pure DCIS at surgical resection will receive Oncotype DX DCIS score testing.

Breast MRI

Only patients with pure DCIS on surgical excision will have advanced pathologic markers and Oncotype Dx DCIS Score testing.

Laboratory Biomarker Analysis

Habib Rahbar

This is a single institution, prospective observational clinical trial for women with mammographically identified calcifications that may represent ductal carcinoma in situ (DCIS).

The purpose of this study is to determine whether quantitative, multiparametric breast MRI performed prior to surgical resection can biologically characterize this common pre-invasive malignancy, ductal carcinoma in situ (DCIS), which typically presents in asymptomatic women as suspicious calcifications on mammography.

The investigators will assess whether MRI signatures can determine which calcifications identified prior to surgical resection actually harbor DCIS, and whether these imaging features correlate with pathologic markers of proliferation (Ki-67) and inflammation (cox-2) within DCIS lesions.

The investigators will also explore whether quantitative MRI features in the peri-tumoral region correlate with prognostic microenvironment markers of inflammation (TNFα) and angiogenesis (VEGF). Finally, investigators will assess whether a multivariate model using these markers can accurately predict risk of recurrence based on a multi-gene assay (Oncotype DX DCIS score).

MRI Characterization of Mammographically Detected DCIS

MRI Characterization of Mammographically Detected Calcifications and Ductal Carcinoma in Situ

Assess whether high f within DCIS lesions correlates with proliferation (high Ki-67)

Assess whether low Dt within DCIS lesions correlates with high proliferation (Ki-67)

Assess whether high Ktrans within DCIS lesions correlates with inflammation (cox-2)

Assess whether low SER can exclude the presence of DCIS-associated malignancy at the site of mammographic calcifications

Assess whether high ADC can exclude the presence of DCIS-associated malignancy at the site of mammographic calcifications

Develop a multivariate MRI model to identify low risk DCIS (Oncotype DX DCIS score\<39)

Assess whether high Ktrans in the peri-tumoral tissue correlates with stromal inflammation (TNFalpha)

Assess whether high f in the peri-tumoral tissue correlates with angiogenesis (VEGF)

National Cancer Institute (NCI)

National Institutes of Health (NIH)

University of Washington

Women with node positive (1-3 nodes), ER positive breast cancer who are receiving (or will receive) endocrine therapy, and who are candidates for chemotherapy.

Study subjects will have ONCOTYPE Dx assay performed on their breast tumors, and will complete study questionnaires.

1. Physician pre-assay questionnaire
2. Patient pre-assay questionnaire
3. Oncotype DX® Assay
4. Physician post- assay questionnaire
5. Patient post-assay questionnaire

Questionnaires, Oncotype Dx Assay

Andrea Eisen, MD

The main goal of this study is to characterize whether the results of the Oncotype DX® assay affect the physician's treatment recommendations for the adjuvant treatment of women with ER-positive (ER+), early breast cancer (EBC) with 1-3 positive lymph nodes who are potential candidates for chemotherapy, but for whom the benefits of chemotherapy may be uncertain.

The Oncotype DX assay has been commercially available in the U.S. since 2004 as a tool to aid a physician's treatment recommendation for a breast cancer patient. While the Oncotype DX assay is currently reimbursed by the Ontario Health Ministry for node-negative EBC, it is not reimbursed for node-positive (N+) patients although the assay has been shown to be both prognostic and predictive of chemotherapy benefit for patients with N+ disease.

The goal of this study is to characterize how the results of the Oncotype DX® assay impact the decision making processes of physicians and patients in a large academic medical center in Ontario by evaluating recommendations for adjuvant therapy within a population of ER+, N+ EBC patients with 1 to 3 positive lymph nodes for whom the benefit of adjuvant chemotherapy is not certain.

Upon consent, the patient will be assigned an ID number. The physician will discuss the patient's treatment alternatives prior to ordering the Oncotype DX assay. After discussion with the patient, the physician will complete a baseline questionnaire indicating the therapeutic strategy he/she would recommend to the patient based upon the available clinical and pathologic data. In addition, the patient will also complete a baseline questionnaire indicating her treatment preference, based on the previous discussion with the physician.

The Oncotype DX assay will be ordered after receipt of the Registration and Confirmation of Eligibility Form and assignment of patient study number. Once the results of the Oncotype DX assay are available, the physician will discuss the results with the patient. Both the physician and the patient will complete separate follow-up post-assay questionnaires after the results of the Oncotype DX assay are known and shared with the patient.

One last form completed by a study manager or coordinator after a treatment plan has been initiated will register the actual treatment administered to the patient.

The Impact of the Oncotype DX® Breast Cancer Assay on Treatment Decisions in a Canadian Population

The Impact of the Oncotype DX® Breast Cancer Assay on Treatment Decisions in a Canadian Population of Patients With Estrogen Receptor- Positive Early Breast Cancer With 1-3 Positive Lymph Nodes

Assessment of actual adjuvant treatment given to patient after Oncotype DX results available

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluating Whether Integration of Prognostic and Predictive Algorithms Into Routine Clinical Practice Effect Whether Oncologists Order Multigene Assays in Patients With Early Stage Breast Cancer	NCT04131933	Breast Cancer		18 Years -	Ottawa Hospital Research Institute
A Prospective Cohort Study to Evaluate the Oncotype DX® Test in Early Stage Breast Cancer	NCT01423890	Breast Cancer	ONCOTYPEDX Test	18 Years -	Ontario Clinical Oncology Group (OCOG)
Engaging Newly Diagnosed Men About Cancer Treatment Options	NCT02668276	Prostatic Neopl...	Standard NCCN c... Standard NCCN c...	- 76 Years	University of Illinois at Chicago
Evaluating Whether Integration of Prognostic and Predictive Algorithms Into Routine Clinical Practice Effect Whether Oncologists Order Multigene Assays in Patients With Early Stage Breast Cancer	NCT04131933	Breast Cancer		18 Years -	Ottawa Hospital Research Institute
(Oncotype DX®) in Estrogen Receptor Positive (ER+) HER-2 Negative (HER 2-) 1-3 Node Positive (pN1) Breast Cancer	NCT02627703	Breast Cancer	Oncotype DX	18 Years - 79 Years	British Columbia Cancer Agency
A Prospective Cohort Study to Evaluate the Oncotype DX® Test in Early Stage Breast Cancer	NCT01423890	Breast Cancer	ONCOTYPEDX Test	18 Years -	Ontario Clinical Oncology Group (OCOG)
MRI Characterization of Mammographically Detected DCIS	NCT03495011	Breast Cancer, ...	Breast MRI Laboratory Biom...	18 Years - 80 Years	University of Washington
The Impact of the Oncotype DX® Breast Cancer Assay on Treatment Decisions in a Canadian Population	NCT02347449	Hormone Recepto...	Questionnaires,...	18 Years -	Sunnybrook Health Sciences Centre
The Impact of the Oncotype DX® Breast Cancer Assay on Treatment Decisions in a Canadian Population	NCT02347449	Hormone Recepto...	Questionnaires,...	18 Years -	Sunnybrook Health Sciences Centre
(Oncotype DX®) in Estrogen Receptor Positive (ER+) HER-2 Negative (HER 2-) 1-3 Node Positive (pN1) Breast Cancer	NCT02627703	Breast Cancer	Oncotype DX	18 Years - 79 Years	British Columbia Cancer Agency

Spots Global Cancer Trial Database for oncotype dx

Every month we try and update this database with for oncotype dx 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 oncotype dx

Every month we try and update this database with for oncotype dx 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 oncotype dx 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.