Attached is the clinical research protocol and rubric, out of the protocol what needs to be developed is the following:1)Treatment Summary Form2)Treat Summary Validation Plan3)Vaccine Administration...

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Attached is the clinical research protocol and rubric, out of the protocol what needs to be developed is the following:1)Treatment Summary Form2)Treat Summary Validation Plan3)Vaccine Administration Form4)Vaccine Administration Form Validation Plan5)Serial Blood Testing Form6)Serial Blood Testing form validation plan7)Off study form8)Off study form validation plan
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Project Summary (limit to 5 pages) Determining the competence of the immune system over the first year of therapy in patients with glioma: a battery of quantitative, qualitative and functional measures of immune readiness Comprehensive Cancer Center of Wake Forest University (CCCWFU) CCCWFU # 01316 Principal Investigator Roy E. Strowd, III, MD Assistant Professor Department of Neurology Department of Internal Medicine Section on Hematology and Oncology Wake Forest School of Medicine Medical Center Boulevard Winston Salem, NC 27157 336-716-3545 [email protected] Co-Investigators Glenn J Lesser, MD Professor of Internal Medicine Section on Hematology and Oncology Wake Forest School of Medicine 336-716-9527 [email protected] Michael Chan, MD Associate Professor Radiation Oncology Wake Forest School of Medicine 336-713-3600 [email protected] Adrian W. Laxton, MD Assistant Professor Department of Neurosurgery Wake Forest School of Medicine 336-716-9457 [email protected] Martha Alexander-Miller, PhD Chair, Microbiology and Immunology Wake Forest School of Medicine 336-716-5936 [email protected] Karen Haas, PhD Assistant Professor Microbiology and Immunology Wake Forest School of Medicine 336-716-0966 [email protected] Katherine Poehling, MD, MPH Professor, Pediatrics Wake Forest School of Medicine 336-716-2588 [email protected] T. Keipp Talbot, MD Assistant Professor of Medicine Assistant Professor of Pediatrics Vanderbilt University Medical Center A2200 MCN 1161 21st Ave South Nashville, TN 37232 Statistician Fang-Chi Hsu Division of Public Health Sciences Wake Forest School of Medicine 336-716-8457 [email protected] Research Nurse Ashley Carroll Comprehensive Cancer Center Wake Forest School of Medicine 336-713-3539 [email protected] Data Manager Jennifer Love Comprehensive Cancer Center Wake Forest School of Medicine 336-713-9890 [email protected] Regulatory Cindy Miller Comprehensive Cancer Center Wake Forest School of Medicine 336-713-6770 [email protected] Participating Institutions Wake Forest Comprehensive Cancer Center Sponsor or Funding Source Wake Forest Center for Translation Sciences Institute – KL2 Mentored Career Development Award Version Date: 05/24/2018 Confidential TABLE OF CONTENTS 1.Abstract6 2.Background, Rationale, and Context8 3.Objectives14 3.1.Primary Objectives14 3.2.Secondary Objective15 3.3.Exploratory Objectives15 4.Methods and Measures16 4.1.Study Design16 4.2.Setting16 5.Subjects Selection Criteria16 5.1.Inclusion Criteria17 5.2.Exclusion Criteria17 5.3.Inclusion of women and minorities17 5.4.Inclusion of pregnant women19 6.Interventions and Interactions19 6.1.Control Patients and Quality Assurance19 6.2.Study Patient Sample Acquisition20 6.3.Quantification of Immune Cells21 6.4.Assessment of Proliferative Ability of Lymphocytes21 6.5.Naïve Immune Response Assessment (Hepatitis A or B Vaccination)22 6.6.Influenza Vaccination (Exploratory Memory Response)27 6.7.Influenza Hospitalization Assessment27 7.Outcome Measure(s)28 7.1.Primary Outcome Measures28 7.1.1.Immune Quantity28 7.1.2.Proliferative Capacity28 7.2.Secondary Outcome Measures28 7.2.1.Naïve Immune Response (Hepatitis Vaccination)28 7.2.2.Memory Immune Response (Tetanus Vaccination)28 7.3.Exploratory Outcome Measures28 7.3.1.Influenza Vaccine Response28 7.3.2.Frequency of Viral Infection28 7.3.3.Overall Survival29 8.Analytical Plan29 8.5.Sample Size30 8.6.Accrual Rate31 9.Human Subjects Protection31 10.Toxicity & Adverse Events31 10.2.Adverse Event Definitions31 10.3.Adverse Event Characteristics32 10.4.Adverse Event Recording32 10.5.Adverse Event Reporting Requirements33 11.Subject Recruitment Methods34 11.2.Recruitment34 11.3.Patient Registration34 12.Table of Required Observations35 13.Off Study Criteria37 14.Informed Consent37 15.Confidentiality and Privacy37 16.Data and Safety Monitoring37 17.Reporting of Unanticipated Problems, Adverse Events or Deviations38 18. Data Management38 19. References39 Appendix A – Protocol Registration Form41 Appendix B – Subject Eligibility Checklist42 Appendix C - Race & Ethnicity Verification Form44 Appendix D – Mandatory STRC SAE Reporting Guidelines45 Appendix E – Study Questionnaire52 Appendix F – Baseline Concomitant Medications Form54 Appendix G – Past Medical History56 Appendix H – Treatment Summary57 Appendix I – Data Collection Form58 Appendix J – Laboratory Form59 Appendix K – Off Study Form61 Appendix L – Adverse Event Log62 SCHEMA 1. Abstract 1.1. Background: Immuno-oncology is a rapidly growing field in oncology today. Oncologic vaccines, adoptive T-cell therapies, and immune checkpoint modulators are amongst the broad therapeutic options being developed. Personalized medicine is an increasingly important therapeutic priority for patients and providers, and patient selection is a critical issue facing clinical trials of immunotherapies. Data (including from Wake Forest) in glioma patients suggests that both cancer and its treatment may impair the immune system which could have important implications for mounting a sufficient response to immune-based therapies. These data suggest that this dysfunction varies throughout cancer treatment. To date, an immunologic battery which assesses immune readiness over time and which can be used to identify optimal timing in a cancer patient’s care for incorporating immunotherapy, has not been developed or tested. 1.2. Study Objective: To describe the quantitative, qualitative, and functional competence of the immune response over the first year of treatment in patients with glioma according to the following three aims: Aim 1: To describe the quantitative and qualitative changes in the immune system which occur over the first year of therapy in patients with glioma including the quantity of immune cells underlying the antitumor immune response and their proliferative capacity (e.g. quality). Aim 2: To describe the readiness of the immune system to respond to an antigenic stimulus using a vaccine-based model of immune response including: (1) the immunologic response to hepatitis vaccination (i.e. naïve response) and (2) the immunologic response to tetanus vaccination (i.e. memory response), both prior to and following chemoradiation, and (3) the immunologic response to influenza vaccination. Aim 3: To describe the frequency of viral infection in glioma patients hospitalized during the respiratory viral season within the first year of therapy. 1.3. Methods: A prospective cohort study will be conducted enrolling 60 patients with newly diagnosed glioma at the time of diagnosis. All 60 patients will be followed over the 1st year of therapy. Patients will undergo standard of care treatment which involves monthly physician visits and blood draws during the first 8 months of therapy followed by bimonthly visits and blood draws thereafter (i.e. 10 blood draws). Methods for Aim 1: During selected visits, blood will be drawn and stored for subsequent immune assessment. Initially, 4 time points will be selected from the 10 specimens: (1) pre-treatment, (2) post-radiation, (3) post-chemotherapy, and (4) post-treatment and samples will be assessed for quantitative and qualitative immune function (i.e. Aim 1). Quantitative Assessment: which will be performed on blood samples from each time point (i.e. pre-treatment, post-radiation, post-chemotherapy, and post-treatment) by flow cytometry of peripheral blood to determine the quantity of each immune cell type (dendritic cells, monocytes, naïve and memory lymphocytes, neutrophils, natural killers, and T-regulatory cells). Qualitative Assessment: which will include (1) carboxyfluorescein diacetate succinimidyl ester (CFSE) assay to assess the proliferative ability of lymphocytes, and (2) a live cell/dead cell distinction assay to discriminate between percent of quantified lymphocytes which are live and dead cells. Methods for Aim 2: All enrolled patients will be randomized 1:1 to either undergo vaccine assessment pre-treatment or post-treatment. At each time point, the immunologic response to two vaccines will be assessed including hepatitis A vaccination (i.e. naïve immune response) and tetanus toxoid vaccination (memory immune response). Immunologic response will be measured to each vaccine by assessing pre-vaccination and 28-day immunogenicity. These two vaccines are currently recommended for this population by the Centers for Disease Control though timing of administration has not been determined. In addition, the immunologic response to the yearly influenza vaccine will be assessed. Patients will receive influenza vaccination as per the standard of care at any point over the first year of therapy and response stratified by time over this first year. Assessment of immune readiness will include: Naïve Vaccination Response Assessment: integrity of the naïve immune response will be assessed at either pre-treatment or post-treatment (as per 1:1 randomization) by measuring the vaccine specific antibody levels to the Hepatitis A vaccine (Hepatitis B vaccine in those who are Hepatitis A exposed). Memory Vaccination Response Assessment: integrity of the memory immune response will be assessed at either pre-treatment or post-treatment (as per 1:1 randomization) by measuring the vaccine specific IgG levels to the tetanus toxoid (i.e. Tdap or Td). In addition, these patients routinely undergo yearly influenza vaccination and over the course of this 1 year study the immunologic re (i.e. Tdap). In addition, patients routinely undergo trive Patients will also undergo assessment of response to influenza vaccination (i.e. memory response) will be assessed. Methods for Aim 3: Clinical Viral Infection: patients hospitalized during the respiratory viral season (including for illnesses other than those that are respiratory) are known to be at higher risk of viral infection which can result in both respiratory and non-respiratory decompensation. The frequency of viral infections (i.e. potential marker of functional immune compromise) will be recorded in all study patients who are hospitalized at Wake Forest Baptist Medical Center during the respiratory viral season and undergo respiratory viral panel as per the current standard of care. 1.4. Significance: Immuno-oncology is a rapidly expanding field in oncology. Critical to the optimal development, translation, and implementation of immunotherapies is patient selection and identifying when to incorporate immune-based therapies into existing treatment algorithms. Gliomas are an ideal model to study. This project will leverage prior experience with this model by these investigators and develop a method of exploring personalized approaches to immunotherapeutic clinical trial development. The vaccines utilized in this study are currently recommended for this population as standard of care. This study will provide preliminary data to develop an immune battery that consists of quantitative, qualitative, and functional measures of immune readiness and will provide the basis for a study validating this battery and using it to identify time points that are most attractive for incorporating immunotherapy in oncology. 2. Background, Rationale, and Context 2.1. Now is Time to Explore Patient Selection in Immuno-Oncology Immunotherapies represent a rapidly developing therapeutic arm in oncology today. Critical advances in the immunologic pathways, translational potential, and drug development have resulted in an expansion of immune-based clinical trials and FDA-approved immunotherapies.1 Immunologic targets in cancer treatment are broad and include enhancement of host responses, modulation of immune checkpoints, regulation of immune signaling within the tumor microenvironment, and others.2 Therapeutic interventions are equally diverse including monoclonal antibodies, tumor vaccines, and others; all of which are being actively developed in oncology now.1 Personalized medicine and precision therapeutics in oncology are increasingly important priorities for patients and providers. Furthermore, patient selection is a crucial issue facing the clinical and translational development of immunotherapies.3 Unlike targeted biologic agents for which tumor genomic information can be used to inform personalized approaches, biomarkers which predict response to immunotherapy will require non-genomic data. Studies are currently evaluating immune-based histopathologic scoring systems which could inform prognostication at diagnosis.3–5 There has been some suggestion that measuring the immune response to a vaccine may correlate with therapeutic response6 and could provide such a biomarker.7 However, few models have been developed or exist. 2.2. Cancer, Radiation, and the Immune System: Timing is critical Oncologists have long suspected that cancer and its treatment result in important immunosuppressive effects which affect outcome and prognosis. . Older age is strongly associated with higher
Answered 3 days AfterJun 02, 2021

Answer To: Attached is the clinical research protocol and rubric, out of the protocol what needs to be...

Asif answered on Jun 06 2021
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Appendix H – Treatment Summary Form
CRM 732 Course – Project #1
Design Form
Patient name: John Le
wis
Date of birth: 20.10.1988
Address: California
Contact Details: 15689630
Record Number: 552
    Diagnosis:
    Diagnosis date:
    starting:
    diagnosed primary central nervous system the astrocytoma...
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