Patient registry

Richard Geer, MD

This is an investigational multi-site outcomes registry intended to collect information about a patient's cancer care. Patients may enter the Registry at any time during the patient's current stage in the continuum of care. The registries main objectives will be to measure and evaluate the effects of patient care throughout the care continuum, resulting in the identification of the most effective treatment options. Objectives will encompass evaluations and analytics around safety, effectiveness, and improved efficiencies.

Sarah Cannon Outcomes Registry

SCRI Development Innovations, LLC

Neoplasms

Nervous System Diseases

Immune System Diseases

All Conditions

Symptoms and General Pathology

Rare Diseases

Myasthenia Gravis

Syndrome

Paraneoplastic Syndromes

Paraneoplastic Syndromes, Nervous System

Nervous System Neoplasms

Autoimmune Diseases

Autoimmune Diseases of the Nervous System

Neurodegenerative Diseases

Neuromuscular Junction Diseases

Neuromuscular Diseases

Mark JW Larkin, PhD

Vitaccess Real MG (VRMG) is a patient registry designed to capture longitudinal observational data on myasthenia gravis (MG), its treatment, and impact on symptoms, daily activities, and quality of life (QoL). The duration of the registry is 10 years from launch, and approximately 600 patients will be recruited in the US and Europe with no defined upper limit. The registry will link relevant patient- and healthcare professional (HCP)-reported data with clinical data from medical records.

Patients will be recruited at clinical sites in all participating countries. In the US only, patients can additionally be recruited via community neurologists or direct-to-patient recruitment.

Traditional site recruitment (all countries):

Adult patients who are being treated for MG at one of the participating clinics or centers in one of the participating countries (the US, UK, Germany, France, or Italy) at the time of enrolment and who meet the inclusion and exclusion criteria will be identified and approached by their clinical team and invited to participate in the registry.

Patient-reported data will be collected via the VRMG Registry platform, a digital data capture platform accessible via smartphone or tablet (from the Apple or Android app store) or via PC. Custom survey and patient-reported outcomes data will be collected at baseline and at regular intervals thereafter for a follow-up period of up to 10 years. The data collected will capture the impact of MG on daily living, fatigue, and health-related quality of life.

Site research teams will complete and update an eCRF (every six months ± one months) for each patient, including data from the patient's EMR. eCRFs that are completed within one months prior to or following each six-month mark will be considered within the same assessment window for analytics purposes so that patients will not be required to visit the clinical site for the purposes of the registry outside of their regular clinical visits.

Community neurologist recruitment (US only):

Community neurologists who are treating MG patients who would be eligible for participation in the registry will be able to register their interest for involvement and provide details of their credentials via an informational website. Approved community neurologists will identify and approach potential participants, who will participate in the registry as normal. Vitaccess will partner with a third-party organization with EMR aggregator capabilities to capture data from participants' existing medical records to match eCRF outputs.

Direct-to-patient recruitment (US only):

A cohort of US-based participants in the MyRealWorld MG study - a longitudinal observational study in MG that Vitaccess has run since 2019 - have provided consent to be contacted by Vitaccess about future research. Vitaccess will contact this patient cohort directly via email to introduce them to the registry; patients can access the registry's informational website to get further information. Patients will participate in the registry as normal. Vitaccess will partner with a third-party organization with EMR aggregator capabilities to capture data from participants' existing medical records to match eCRF outputs.

Patient-reported and eCRF data will be linked via a unique ID and PIN assigned to each participant at enrolment.

Vitaccess Real MG Registry

Vitaccess Real MG Registry: A Prospective International Observational Patient Registry in Myasthenia Gravis Linking Clinical and Patient-reported Data.

A patient registry designed to capture longitudinal observational data on myasthenia gravis (MG), its treatment, and impact on symptoms, daily activities, and quality of life.

EMR data reported by HCPs or captured via EMR aggregators ("Registration Form")

EMR data reported by HCPs or captured via EMR aggregators ("Clinical Trial Participation Form")

EMR data reported by HCPs or captured via EMR aggregators ("Diagnosis Information Form")

EMR data reported by HCPs or captured via EMR aggregators ("Clinical Characteristics Form")

EMR data reported by HCPs or captured via EMR aggregators ("Medical History Form")

EMR data reported by HCPs or captured via EMR aggregators ("Concomitant Medication Log")

EMR data reported by HCPs or captured via EMR aggregators ("Routine MG Treatments Log")

EMR data reported by HCPs or captured via EMR aggregators ("Rescue MG Treatments Log")

Myasthenia Gravis Activities of Daily Living (MG-ADL) data reported by HCPs or captured via EMR aggregators ("MG-ADL")

EMR data reported by HCPs or captured via EMR aggregators ("Healthcare Resource Use")

EMR data reported by HCPs or captured via EMR aggregators ("Adverse Events")

Myasthenia Gravis Activities of Daily Living (MG-ADL) data reported by patients via the Vitaccess Real MG Registry platform ("MG-ADL")

MG Symptoms PRO Fatigue Component data reported by patients via the Vitaccess Real MG Registry platform ("MG Symptoms PRO Fatigue Component")

NeuroQoL Fatigue Short Form data reported by patients via the Vitaccess Real MG Registry platform ("NeuroQoL Fatigue Short Form")

Myasthenia Gravis Quality of Life 15-item revised scale (MG-QoL-15r) data reported by patients via the Vitaccess Real MG Registry platform ("MG-QoL-15r")

Vitaccess Ltd

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Uterine Cervical Neoplasms

Endometrial Neoplasms

Fallopian Tube Neoplasms

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Neoplasms

Uterine Diseases

Fallopian Tube Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Fallopian Tube Cancer

Clinical data, specific procedures and treatments will follow the Institutional standard operative procedures

Jeong-Yeol Park, PhD

So Hyun Nam, MD

Jeong-Yeol Park, M.D., Ph.D.

The goal of this observational study is to identify and analyze the characteristics, treatment trends, prognostic factors and survival prognosis of Korean gynecologic cancer patients. Ultimately, the final goal is to contribute to the development of safe surgical methods and treatment for gynecologic cancer to improve survival rates.

Cervical cancer, endometrial cancer, and ovarian cancer represent gynecologic cancers. There are many open issues that need to be addressed, specifically the surgical method, disease recurrence and survival outcome in the so called "real world" setting. The aim of this observational study is to collect both retrospective and prospective medical information of gynecologic cancer patients.

Development and Management of Registry in Patients With Gynecologic Cancer in Korea

Analyzed for all patients as time from diagnosis to death as a result of any cause, stratified according to baseline characteristics, surgical methods, and treatment

Analyzed for all patients, as time from diagnosis to progression of disease or death as a result of any cause, stratified according to baseline characteristics, surgical methods, and treatment

Asan Medical Center

Professor

Participants receiving one of the 11 listed therapy modalities.

Radiation Therapy

William Regine, MD

This study will create a patient data registry to collect and analyze information on technology usage and outcomes among patients receiving a broad range of relatively new radiation treatments that have become standards of care in our practice. Review of this information will serve as a basis for development of better patient management plans, to inform decisions about acquisition of new technologies, to provide information about quality in our care delivery, and to create a database that will securely warehouse ongoing information about what treatments the patients we serve need most and the challenges they face in the treatment process. The information gathered is likely to not only improve our services at the University of Maryland and its community sites but to advance medical science and enhance the quality of care for cancer patients.

The purpose of this study is to create a robust and long-term patient data registry containing limited demographic, diagnostic, treatment, and follow-up data on patients at the study sites undergoing one or more of the following radiation treatments/technologies:

Brachytherapy, including High-Dose-Rate and Low-Dose-Rate Techniques/ GammaPod Therapy/ GRID Treatment/ Image-Guided Radiation Therapy/ Intensity-Modulated Radiation Therapy and Intensity-Modulated Arc Therapy/ MammoSite and SAVI Applicator/ Photodynamic Therapy/ Proton Therapy/ SIR Spheres and Radiolabeled Microsphere Therapy/ Stereotactic Radiosurgery and Stereotactic Body Radiotherapy/ Thermal Therapy (Hyperthermia)

Prospective Patient Registry for Radiation Oncology Techniques and Quality

Patient Registry for Prospective Research on Evolving Radiation Oncology Techniques and Quality

Records will be assessed to identify per-patient numbers and grades of toxicities and adverse events resulting from radiation treatment for oncologic conditions as graded by treating physicians according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) during the period of radiation treatment and at each regularly scheduled clinical follow-up appointment, for each of the 11 therapeutic modalities listed as interventions.

Records will be assessed to identify numbers of patients with specific initial diagnoses (from approximately 100 International Statistical Classification of Diseases and Related Health Problems \[ICD 9\] malignant neoplasm diagnoses) who experience short- and long-term toxicities after any of the 11 therapeutic modalities listed as interventions.

Records will be assessed to identify numbers of men and women who experience CTCAE-defined levels of toxicity during and after radiation treatment with any of the 11 therapeutic modalities listed as interventions.

Records will be assessed to identify numbers of men and women between the ages of 18-30, 31-40, 41-50, 51-60, 61-70, 71-80, 81-90, and ≥90 years who experience CTCAE-defined levels of toxicity during and after radiation treatment with any of the 11 therapeutic modalities listed as interventions.

Records will be assessed for income (by patient home zip code per U.S. Internal Revenue statistics available at http://www.irs.gov/uac/SOI-Tax-Stats-Individual-Income-Tax-Statistics-ZIP-Code-Data-(SOI)) to identify income level differences and per-patient numbers/ types of CTCAE-defined levels of toxicity during and after radiation treatment with any of the 11 therapeutic modalities listed as interventions.

University of Maryland, Baltimore

Principle Investigator

Blood and Lymph Conditions

Infections

Hematologic Neoplasms

Aspergillosis

Hematologic Diseases

Mycoses

Bacterial Infections

Communicable Diseases

Bacterial Infections and Mycoses

Anti-Infective Agents

All Drugs and Chemicals

Clotrimazole

Miconazole

Antifungal Agents

Registry

Oliver A. Cornely, Prof.

Paul E. Verweij, Prof.

In order to determine the efficacy of antifungal therapy in patients with documented azole-resistant invasive Aspergillosis (IA), anonymized clinical information of patients with a hematological malignancy with a culture-positive invasive fungal infection caused by Aspergillus fumigatus are collected in an online registry. Respective fungal isolates are analysed for azole susceptibility and resistance mechanisms. Patients diagnosed with an IA in 2016 and later are included in the study.

For mold-active azoles (e.g. isavuconazole, itraconazole, posaconazole and voriconazole), cross-resistance of Aspergillus spp. is an increasingly recognized problem. The study aims to determine the efficacy of antifungal therapy in patients with documented azole-resistant IA. On the basis of this study, it will be possible to assess the clinical implications of IA caused by azole-resistant versus azole-susceptible Aspergillus spp.

The investigators aim at collecting at least 55 azole-resistant and 130 azole-susceptible cases. Cases diagnosed with an IA by culture from January 1st, 2016 onwards with an underlying hematological malignancy are eligible for inclusion. Culture of azole-resistant cases must be provided for confirmation of the species, sequencing for azole-resistance mutations and determination of MIC using the EUCAST reference method. Isolates obtained from patients with presumed azole-susceptible disease will be analyzed to confirm the wild type phenotype.

Eligible azole-resistant and azole-susceptible IA cases will be documented using the web-based case report form. If there is ≥1 resistant isolate, the patient fulfills the definition of a resistant case. Patient level data will be recorded at the respective study centres in a continuous fashion. Data items to be documented will include: demographic data; type and status of underlying conditions; concurrent immunosuppressive treatment; diagnostic measures (clinical presentation, radiology, microbiology, pathology, organ involvement); medical and surgical treatment (including prior exposure to antifungals); response to treatment (clinical and radiological) at day 14, 42, 84; overall survival at day 14, 42, 84 and at last contact; and cause of death (if applicable).

Clinical Implications of Azole-Resistant Aspergillosis in Hematological Malignancy

CLARITY - Clinical Implications of Azole-Resistant Aspergillosis in Hematological Malignancy

IPD will not be shared with unauthorized persons. Anonymized data will only be exchanged between study coordinators and the analysis team.

Analysis of efficacy of antifungal therapy of azole-resistant and azole-susceptible invasive Aspergillosis. Patient receive either complete response, partial response, stable disease, progression of the disease. Treatment response will be assessed by treating physicians. Response will be compared between the two groups.

Final outcome will be compared between the two groups in consideration of the type and state of underlying diseases and risk factors.

Radboud University Medical Center

University Hospital of Cologne

Prof.

Musculoskeletal Diseases

Muscle Weakness

Paresis

Asthenia

Muscular Diseases

Neuromuscular Manifestations

Neurologic Manifestations

Complement System Proteins

Eculizumab

Alexion Pharmaceuticals, Inc. (Sponsor)

Long-term, multicenter, multinational, observational, registry of patients with gMG that is designed to collect data on clinical outcomes and safety in patients prescribed Alexion C5 inhibitor therapies (C5IT) such as eculizumab (Soliris®) and ravulizumab (Ultomiris®).

At the time of enrollment in the Registry, participant records will be queried for retrospective information about the participants' medical history and gMG disease treatment history. Following enrollment, prospective data collection will be performed using data obtained as part of the routine clinical care and through patient-reported outcome methods in use. Data will be collected using an electronic data capture system. The duration of data collection for the Registry will be up to 5 years from the day of enrollment.

Registry of Participants With Generalized Myasthenia Gravis Treated With Alexion C5 Inhibition Therapies (C5ITs)

Long-Term, Observational, Global Registry of Patients With Generalized Myasthenia Gravis Who Have Received Treatment With Complement C5 Inhibition Therapies (C5ITs)

The MG-ADL is an eight-item patient-reported outcome measure assessing MG symptoms and functional activities related to activities of daily living.48 Each of the items is scored from 0 (normal) to 3 (most severe), providing a total MG-ADL score ranging from 0 to 24, where higher scores indicate greater severity of symptoms.

Alexion Pharmaceuticals, Inc.

Lymphoma

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

establish a cohort of patients with lymphoma in China and follow up the patients for a long period of time

Yuqin Song, Ph D

Jun Zhu, Ph D

Lymphoma is the most common hematologic tumor. It is derived from lymphoid tissue, including Hodgkin's lymphoma(HL) and non Hodgkin's lymphoma(NHL). The treatment of lymphoma includes chemotherapy, radiotherapy, stem cell transplantation, targeted therapy and surgery etc. With the progress of treatment, the survival rate of lymphoma patients has been improved. But the 5 year survival rate of lymphoma in China is shorter than that in United States. The reason is that there is still a gap between China and the United States in disease screening, diagnosis and treatment.

Observational studies, especially cohort studies, are important tools for understanding disease progression, treatment, and prognosis in the real world. Observational cohort studies which involve over 500 patients are currently launched by South Korea and the United States. China, which has more patients, doesn't have a cohort of patients with lymphoma. So the primary objective of this study was to establish an observational cohort of patients with lymphoma in China and follow up the patients for a long period of time to provide basic support for clinical research and drug development, and continuously improve patient outcomes and quality of life. The secondary objective is to collect information about diagnosis, treatment, follow-up and prognosis of lymphoma.

China Lymphoma Patient Registry Study

Understand the characteristics of lymphoma in China,such as the distribution of sex,age,histological type and clinical stage etc

Overall survival is defined as the time from disease to death

Peking University First Hospital

Tianjin Medical University Cancer Hospital

Zhejiang Cancer Hospital

Heilongjiang Cancer Hospital

Sipai(Beijing)Network Technology Co Ltd

Jun Zhu

Director of lymphoma department

Desmoplastic Small Round Cell Tumor

Sarcoma

Neoplasms, Connective and Soft Tissue

Soft Tissue Sarcoma

Collect historical/longitudinal clinical, radiographic and molecular features of DSRCT patients as documented in medical records to improve knowledge about DSRCT

Emily Slotkin, MD

Shakeel Modak, MD

This study is a patient registry of people with Desmoplastic Small Round Cell Tumor (DSRCT). A patient registry is a collection of health information about a group of people, and it is usually focused on a specific diagnosis or disease.

The purpose of this registry is to create a database- a collection of information-or better understanding DSRCT. Researchers will use the information from this database to learn more about DSRCT and for current and future research on DSRCT.

Registry to Collect Health Information About Desmoplastic Small Round Cell Tumor

Registry for Patients With Desmoplastic Small Round Cell Tumor

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

The aim of this study is the collection of data.

Memorial Sloan Kettering Cancer Center

Sushan Luo, MD, PhD

Hua Zhang

Yuwei Da

Yuzhou Guan

Fei Xiao

Huiyu Feng

Wei Qiu

Bo Song

Huan Yang

Qun Xue

Yong Zhang

Daojun Hong

Hui Deng

Chongbo Zhao

Ting Chang

Hongyu Zhou

Chunsheng Yang

Myasthenia gravis (MG) is an autoimmune disease caused by dysfunction at the neuromuscular junction, characterized by partial or generalized skeletal muscle weakness and fatigability. The estimated annual incidence rate of MG in China is 0.68/100,000, with a high rate of relapse and poor treatment compliance. This study is a prospective, observational, multi-center patient registry across China. To support standardized management and follow-up of MG patients in China, a Cloud-based MG Patient Management Platform (CN MG Base) was established in September 2023 with the support of the Chinese Rare Diseases Alliance. The platform aims to collect longitudinal clinical data including demographic information, age of onset, medical history, comorbidities, medication usage, treatment responses, and others. It is intended to collect newly registered MG cases each year and follow up with these patients at one-year intervals for ten years

This study is a observational nationwide multicenter MG registry research. Starting from the baseline, annual follow-ups will be conducted to prospectively collect information on treatment medications, prognosis, and safety events. The following classification definitions can be applied: ① MG clinical subtypes (ocular, early-onset generalized, thymoma-related, late-onset generalized, MuSK-related, and seronegative); ② Different treatment methods (classic immunotherapy group, B-cell-targeted therapy, complement inhibition therapy, rapid-acting therapy, and IL-6 pathway inhibitors, etc.).

Whole blood, Plasma, Serum, Blood RNA extraction

Myasthenia Gravis Registry in China

The proportion of patients achieving minimal symptom expression (MSE, defined as reaching an ADL score of 0 or 1) after treatment.

Safety events including upper respiratory tract infection, lower respiratory tract infection, urinary tract infection, and other infections;

Having reached MSE for over a year but experiencing a symptom relapse, manifested as an increase in ADL score greater than or equal to 2 points.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Sarah Cannon Outcomes Registry	NCT02356822	Oncology	Patient registr...	18 Years -	SCRI Development Innovations, LLC
Vitaccess Real MG Registry	NCT06064461	Myasthenia Grav...		18 Years -	Vitaccess Ltd
Development and Management of Registry in Patients With Gynecologic Cancer in Korea	NCT05912972	Cervical Cancer Endometrial Can... Ovarian Cancer Fallopian Tube ... Peritoneal Canc...	Patient registr...	18 Years -	Asan Medical Center
Prospective Patient Registry for Radiation Oncology Techniques and Quality	NCT02368106	Solid Tumors Cancer	Radiation Thera...	18 Years -	University of Maryland, Baltimore
Sarah Cannon Outcomes Registry	NCT02356822	Oncology	Patient registr...	18 Years -	SCRI Development Innovations, LLC
Prospective Patient Registry for Radiation Oncology Techniques and Quality	NCT02368106	Solid Tumors Cancer	Radiation Thera...	18 Years -	University of Maryland, Baltimore
Vitaccess Real MG Registry	NCT06064461	Myasthenia Grav...		18 Years -	Vitaccess Ltd
Clinical Implications of Azole-Resistant Aspergillosis in Hematological Malignancy	NCT03221075	Invasive Asperg...	Registry	-	University Hospital of Cologne
Registry of Participants With Generalized Myasthenia Gravis Treated With Alexion C5 Inhibition Therapies (C5ITs)	NCT04202341	Generalized Mya...		-	Alexion Pharmaceuticals, Inc.
China Lymphoma Patient Registry Study	NCT03313271	Lymphoma		18 Years -	Peking University
Registry to Collect Health Information About Desmoplastic Small Round Cell Tumor	NCT04690374	Desmoplastic Sm...		-	Memorial Sloan Kettering Cancer Center
Myasthenia Gravis Registry in China	NCT06241521	Myasthenia Grav...		-	Huashan Hospital
Bergamo Lymphoid Cancer Registry	NCT03131531	Hodgkin Lymphom... Non Hodgkin Lym... Myeloma	Patient registr...	18 Years -	A.O. Ospedale Papa Giovanni XXIII
Sarah Cannon Outcomes Registry	NCT02356822	Oncology	Patient registr...	18 Years -	SCRI Development Innovations, LLC
Development and Management of Registry in Patients With Gynecologic Cancer in Korea	NCT05912972	Cervical Cancer Endometrial Can... Ovarian Cancer Fallopian Tube ... Peritoneal Canc...	Patient registr...	18 Years -	Asan Medical Center
Registry to Collect Health Information About Desmoplastic Small Round Cell Tumor	NCT04690374	Desmoplastic Sm...		-	Memorial Sloan Kettering Cancer Center

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