Symptoms and General Pathology

All Conditions

Diseases and Abnormalities at or Before Birth

Digestive System Diseases

Heart and Blood Diseases

Blood and Lymph Conditions

Neoplasms

Rare Diseases

Hemorrhage

Congenital Abnormalities

Gastrointestinal Hemorrhage

Telangiectasis

Arteriovenous Malformations

Telangiectasia, Hereditary Hemorrhagic

Angiodysplasia

Melena

Hemangioma

Vascular Diseases

Gastrointestinal Diseases

Vascular Malformations

Cardiovascular Abnormalities

Neoplasms, Vascular Tissue

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Hemorrhagic Disorders

Hematologic Diseases

Hereditary Hemorrhagic Telangiectasia

Anti-Infective Agents

Antineoplastic Agents

All Drugs and Chemicals

Thalidomide

Immunosuppressive Agents

Immunologic Factors

Anti-Bacterial Agents

Angiogenesis Inhibitors

Growth Inhibitors

Atul Kumar, MD

James Gossage, MD

The purpose of this study is to determine whether Thalidomide is effective in the treatment of arteriovenous malformations in the gastrointestinal tract.

Arteriovenous malformations (AVM's) are the commonest vascular abnormalities of the gut. AVM's or Angiodysplasia may be acquired or inherited as in a hereditary hemorrhagic telangiectasia (HHT). Repeated episodes of gastrointestinal bleeding (GIB), especially in the elderly have been attributed to angiodysplasia. Clinically significant GIB may be also seen in up to 40% of HHT patients, usually in the fourth and fifth decades of life. GIB may manifest both as acute major hemorrhage, slow intermittent blood loss or a combination of these findings and patients may be symptomless, present with acute bleeding or iron deficiency anemia. Recurrent hemorrhage and persistent iron-deficiency anemia is common despite supplemental iron therapy and patients require repeated transfusions. Amongst patients with preexisting co-morbidities, repeated bleeding may lead to significant morbidity and mortality. Furthermore, re-bleeding among these patients consumes a disproportionate share of healthcare resources devoted to multiple admissions, repeated endoscopies and blood transfusions. There are no effective treatment options available currently. The purpose of this study is to determine whether Thalidomide is effective in the treatment of arteriovenous malformations in the gastrointestinal tract.

Thalidomide Reduces Arteriovenous Malformation Related Gastrointestinal Bleeding

Augusta University

University of Massachusetts, Worcester

Northport Veterans Affairs Medical Center

Atul Kumar

Respiratory Tract (Lung and Bronchial) Diseases

Neoplasm Metastasis

Syndrome

Hemoptysis

Mediastinal Diseases

Superior Vena Cava Syndrome

Lung Diseases

Respiratory Tract Diseases

Signs and Symptoms, Respiratory

Thoracic Diseases

* All patients will undergo volumetric MR imaging on treatment days in positioning appropriate for the specific treatment site.
* Patients will receive standard of care palliative radiation therapy

This will most frequently be supine with arms positioned so not in the way of treatment beams.

Volumetric MR imaging

Radiation therapy

Hyun Kim, M.D.

This proposed study is unique in that patients will not undergo computed tomography (CT) simulation at any point during their treatment course and will instead have same-session magnetic resonance (MR)-only simulation and treatment planning, on-table, using the adaptive radiotherapy (ART) workflow. In this manner, patients requiring urgent treatment could initiate treatment as early as the day of initial radiation oncology consultation.

Same-session MR-only Simulation and Treatment With MRI-guided Adaptive Palliative RadioTherapy

Pilot Study of Same-session MR-only Simulation and Treatment With MRI-guided Adaptive Palliative RadioTherapy (MAP-RT)

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures and appendices). Participants who opted out of data sharing in the informed consent will not be included.

Washington University School of Medicine

Volumetric MR Imaging Planning

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Feasibility of Same-session MRI-only Simulation as Defined as More Than 70% of Patients Receiving at Least 70% of Their Scheduled Treatment Fractions on the First On-table Attempt for Each Respective Fraction.

Overall Study

Ear, Nose, and Throat Diseases

Nervous System Diseases

Epistaxis

Intracranial Arteriovenous Malformations

Nose Diseases

Otorhinolaryngologic Diseases

Cerebrovascular Disorders

Brain Diseases

Central Nervous System Diseases

Central Nervous System Vascular Malformations

Nervous System Malformations

Intracranial Arterial Diseases

Intracranial Arteriovenous Malformation

Those diagnosed with HHT based on the Curacao diagnostic criteria or genetic testing

Melissa A Dickey, MSN

Nolie Krock, MSc

Sayeh Jafari

Victoria Rueda

Justin McWilliams, MD

Lucas Cusumano, MD

Lindsay Park, MS

Steven Hetts, MD

Miles Conrad, MD

Johan Allingmon

Peter Hountras, MD

Katharine Henderson

Jeffrey Pollak, MD

Melissa James, RN

Madeleine Macy, BS

Carolena Othman, MS

Josanna Rodriguez-Lopez, MD

Greg Schwichtenberg

Sue Ann Donlinger

Vivek Iyer, MD

Melissa Beasley, AA

Kristine Kempf

Murali Chakinala, MD

Kelsey Weddig, RN, BSN

Charles Murphy, MD

Karen Smith, RN

Kristi Kirkland

Raj Kasthuri, MBBS

Lori Russell, RN

Eleanor Lottsfeldt, BA

Mark Chesnutt, MD

Claire Kaufman, MD

Ala Streater, BS

Isaac Elysee, MS

Theodore Drivas, MD

Mhd Wisam Alnablsi, MD

John Battaile, MD

An Lu, MD

Cassidy Sion, RN, BSN

Kevin Whitehead, MD

The Comprehensive HHT Outcomes Registry of the United States (CHORUS) is an observational registry of patients diagnosed with Hereditary Hemorrhagic Telangiectasia (HHT). The purpose of this study is to better understand HHT, the symptoms and complications it causes, and the impact the disease has on people's lives. The investigators will collect long-term information about the participant, allowing us to understand how the disease changes over time, and what factors can influence those changes. Ultimately, this should help improve treatments for the disease.

Another important goal of the study is to provide a way to contact people to participate in future clinical trials and other research. The registry will be a centralized resource for recruitment for clinical trials. People in the registry will not be obligated to join any of these additional studies, but if interested, can agree to be contacted if they may be eligible for a study.

Participants will:

* Be asked to provide permission to collect information from their medical records, including things like demographic information, diagnosis information, family history, test results, treatment information, symptoms, complications, lifestyle and other relevant medical information.
* Be asked study-related questions by phone or at a clinic visit.
* Be asked study-related questions every year after enrollment for up to 10 years or until the study ends. A member of the study team will communicate with participants by phone or at clinic visits to collect information regarding any changes to their health over the previous year/s including new test results, treatment information, symptoms, and complications from HHT.

The Comprehensive HHT Outcomes Registry of the United States (CHORUS) is a research initiative led by the HHT Foundation International, Inc. ("Cure HHT"). The study focuses on Hereditary Hemorrhagic Telangiectasia (HHT), a rare genetic disorder characterized by the development of abnormal blood vessels in various organs of the body, including the brain, spine, lungs, liver, GI tract, skin, nasal mucosa, and oral cavity. The prevalence of HHT is estimated to be 1 in 5000, affecting children and adults. These abnormal blood vessels can lead to acute and chronic bleeding, stroke, heart failure, and death. Treatments are currently predominately limited to managing complications, while approximately 90% of adults have ongoing symptoms, despite the best surgical and medical therapies. With recent drug developments related to angiogenesis, there is hope for effective novel therapies.

A natural history registry for HHT has significant implications for improving the understanding and management of this rare genetic disorder. The purpose of this study is to better understand HHT, the symptoms and complications it causes ("outcomes"), and to understand how the disease impacts people's lives. The investigators hypothesize that a natural history registry for HHT will improve our understanding of the disease, lead to better management of patients, and ultimately, contribute to developing novel therapies to treat this disease.

The investigators will collaborate with multiple HHT Centers of Excellence across the U.S. to establish a comprehensive registry of HHT patients. The study aims to enroll approximately 10,000 HHT patients over a 10-year period. Longitudinal data will be collected both retrospectively and prospectively, with a focus on increasing the understanding of this rare disease, accelerating the development of new diagnostic and treatment options, and working collaboratively with clinicians who care for individuals with HHT to identify and address gaps in the system of care, especially those from underserved populations.

The study aims to serve as a centralized resource for future clinical trials and research in HHT. Data security and confidentiality are prioritized, and participants have the option to withdraw from the study at any time. The study is funded by the U.S. Department of Health Resources and Service Administration (HRSA) through a grant awarded to Cure HHT.

Comprehensive HHT Outcomes Registry of the United States (CHORUS)

CHORUS: Comprehensive HHT (Hereditary Hemorrhagic Telangiectasia) Outcomes Registry of the United States

Utilizing the "HHT Baseline Assessment Scale," this measure focuses on recruiting a diverse cohort of HHT patients across North America. Comprehensive baseline clinical, demographic, and lifestyle data will be collected and entered into CHORUS. The data, aggregated as mean change from baseline using the scale, will serve as a foundational resource for future clinical translational studies, addressing the urgent need for natural history data in HHT.

Utilizing the "HHT Clinical Outcomes Scale," this measure aims to prospectively and longitudinally assess the clinical outcomes of HHT patients. Determinants such as demographic factors, environmental influences, lifestyle choices, comorbidities, medications, HHT-genotype, and organ vascular malformations (VMs) will be measured. The data, aggregated as mean change from baseline using the scale, will enhance understanding and accelerate the development of new diagnostic and treatment options for HHT.

Description: Utilizing the "HHT Clinical Outcomes Scale," this measure aims to prospectively and longitudinally assess severe complications in HHT. This measure focuses on measuring rates of severe complications in HHT. Determinants of these complications will be characterized, and the data will be aggregated as mean change from baseline using the index, providing valuable insights into the disease progression.

Description: Utilizing the "Epistaxis Severity Scale," this measure aims to characterize epistaxis in adults with HHT, considering aspects such as frequency, duration, intensity, and variability. Outcome determinants related to epistaxis will be elucidated, and the data will be aggregated as mean change from baseline using the scale to inform comprehensive patient care.

Utilizing the "Organ VMs Assessment Tool," this measure involves the prospective measurement of the development and growth of organ vascular malformations (VMs) in HHT patients over time. Outcome determinants related to these VMs will be investigated, and the data will be aggregated as mean change from baseline using the tool, contributing to a better understanding of disease progression.

Utilizing the "HHT Treatment Outcomes Scale," this measure involves the prospective measurement of treatment outcomes for HHT and its clinical manifestations. Treatment outcome determinants will be characterized, and the data will be aggregated as mean change from baseline using the scale to guide effective management strategies for patients with HHT.

The Cleveland Clinic

Mayo Clinic

Massachusetts General Hospital

Columbia University

Oregon Health and Science University

University of California, Los Angeles

University of California, San Francisco

University of Colorado, Denver

University of North Carolina, Chapel Hill

University of Pennsylvania

University of Texas

University of Utah

Yale University

Health Resources and Services Administration (HRSA)

Children's Hospital of Philadelphia

Cure HHT

Infections

Adenoma

Colonic Polyps

Respiratory Tract Infections

Polyps

Neoplasms, Glandular and Epithelial

Intestinal Polyps

Pathological Conditions, Anatomical

Herbal and Botanical

Cola

hot snare

cold snare

Marina de Benito, MD

Colonoscopy is the technique of choice for the diagnosis and prevention of colorectal cancer (CRC). The identification and extirpation of adenomas decreases the incidence of CRC by up to 76%. More than 70% of the excised lesions are less than 10 mm. There is controversy about the technique to be used (resection with cold vs hot snare) in lesions of 5-9mm. Both use a polypectomy snare. The cold snare cuts by friction, while the hot snare uses electrical current. We propose a multicenter randomized clinical trial comparing both endoscopic techniques. At least 394 injuries per group will be included, randomizing patients to whom a diagnostic colonoscopy is requested for symptoms, screening or revision protocols. Randomization will be performed stratified by center. The primary objective is the proportion of incomplete polypectomies, which will be analyzed centrally from random biopsies of the edges of the lesion. As secondary objectives, we will compare the proportion of immediate and delayed hemorrhagic complications, the evolution of postprocedural abdominal pain and the factors associated with incomplete excision in each group and the factors associated with a failed cold polypectomy. The analysis of the primary objective will be carried out by means of the z test of homogeneity without using the correction of Yates, estimating the confidence interval of the difference between both groups. The analysis will be carried out by intention to treat and per protocol.

1. Introduction

   Colorectal cancer (CRC) is a major cause of morbidity and mortality worldwide. It is estimated that in 2008, 1233,000 new cases were diagnosed and more than 600,000 people died for this reason throughout the world. Colonoscopy is the technique of choice for both diagnosis and prevention, since the identification and removal of colonic adenomas reduces the incidence of CRC by up to 76%.

   Different endoscopic techniques have been developed for the removal of adenomas; The choice of some over others is made according to the size, morphology and location of the lesion.
2. Hypothesis

   Conceptual hypothesis:

   Cold snare polypectomy presents a proportion of incomplete polypectomies similar to polypectomy with hot snare.

   Operational hypothesis:

   Two endoscopic techniques will be compared from two groups created by a random assignment to one or another type of polypectomy, evaluating the proportion of non-excised polypoid tissue after it. This will be done from random biopsies of the edges of the lesion and possible macroscopic remnants
3. Objectives.

   Primary objective:

   To compare the proportion of incomplete polypectomies in both types of polypectomy (cold snare vs. hot snare).

   Secondary objectives:

   Comparing the proportion of immediate and delayed bleeding complications, total and according to the severity that they present according to the American Society of Gastroenterology (ASGE) classification.

   Comparing the evolution of abdominal pain in the 5 hours postprocedure between both groups.

   Evaluating factors associated with an incomplete extirpation in each group. Evaluating factors associated with a failed cold polypectomy.
4. Design

   Multicenter randomized clinical trial
5. Methods

Study population Patients scheduled to undergo a colonoscopy in a non-urgent setting. Patients will be invited to participate before performing the colonoscopy.

Randomization It will be done once the patient agrees to participate in the work and the first candidate polyp has been identified. Each patient will be randomized (regardless of the number of lesions per patient) so all lesions of each patient will be removed in the same way. It will be stratified by center.

Intervention Patients who meet the inclusion criteria and do not present any exclusion criteria (pre-endoscopic) will be invited to participate in the study. The informed consent will be completed according to the Spanish law 41/2002 of autonomy of the patient.

1. Endoscopic procedure The interventions will be carried out in each of the participating centers. The examinations will be performed under sedation according to the protocols established in each center. Once the first lesion is identified, the method of extirpation of the lesion will be randomized.

   * Cold Group: polypectomy with a cold snare will be carried out according to the usual standards recommended by international societies. The lesion should be placed if possible in the position equivalent to 5 o'clock on the dial, the end of the snare will be placed several millimeters from the lesion and the tip of the catheter will be angled downwards, without aspiration at any time to avoid entrapment of the submucosa.
   * Hot Group: polypectomy with snare connected to the electrosurgical unit according to the standards recommended by international societies, using a mixed current (cut-coagulation). Once the lesion is captured, the snare is pulled up to slightly separate it from the surrounding mucosa before polypectomy. Elevation of the lesion prior to polypectomy will not be performed.
   * Common evaluation: once the polypectomies are completed, the base of the polypectomies will be evaluated, taking biopsies from any suggestive area and also 2 random biopsies at the base of the polypectomy.
2. Postendoscopic follow-up After a minimum of 21 days and a maximum of 28 days from the endoscopic examination, the patient will be contacted by telephone to collect the form about the evolution of the abdominal symptoms and to collect data about the appearance of complications (questions will be asked about visits to the hospital and in a targeted manner about the most frequent symptoms of the usual complications (fever, hemorrhage, abdominal pain).
3. Histological analysis The analysis of the specimens of the polypectomies will be carried out in each center according to their usual protocol. The analysis of the biopsies of the base of the polyp will be carried out centrally by a pathologist with more than 5 years of experience in digestive pathology. Samples from the base of the polyp will be sent periodically from each center to the Salamanca university hospital through a messenger service. The pathologist will be blinded regarding the histological diagnosis of the excised polyp and the type of polypectomy (although it is true that it is difficult to blind this last point since the presence of heat artifacts in those removed with a hot handle is very frequent). The samples sent for centralized analysis will not be stored, but will be destroyed once the study is completed according to standard protocols.

Sample size Assuming a proportion of incomplete polypectomies in both groups of 10% (using the taking of biopsies as a diagnostic pattern) and setting an equivalence limit of 7%, a total of 315 lesions per group are estimated to have an α risk of 5% and a power of 80%. Assuming a proportion of losses (polyps not recovered for histological study, polypectomies of the failed Cold group of 20%), an estimated 394 lesions per group are needed, with a total of 788 lesions in total.

Data Collection All the variables concerning the characteristics of the endoscopist, the patient and the injuries included will be collected in each center. The variables related to the histological diagnosis will be collected in the same way in the respective center. The variables concerning the follow-up will be collected in a centralized manner, through a telephone call that will be made between 3 and 4 weeks from the procedure. The variable related to the histological study of the base of the polyp will be collected in a centralized manner by the pathologist in charge of the analysis of the samples.

6. Data management

Data from the data collection notebooks will be merged by the main researcher or collaborating researchers anonymously, encrypted and dissociated from the clinical information by means of a patient identification code (ID), in an online database. A copy of the database will be used in each participating center, which will be merged after completing the data collection. The responsible researcher will define an ID for each participant. The data entered in the database will be anonymous and the database will be protected with a password to which only the researchers will have access.

The unified file will be kept at the Río Hortega University Hospital and will be maintained until the end of the study. Regarding the application of the Organic Law on Data Protection 15/1999 and 1720/2007 that develops it, it should be noted that the protocol defined in the project oriented to epidemiological analysis, determines that the files will record information completely anonymized

7. Statistical analysis

The Access program (Microsoft Corporation, Edmond, USA) will be used for the realization of the database and the statistical analysis of them will be carried out through the STATA program (StataCorp, 2013. Stata Statistical Software: Release 13. College Station, StataCorp LP). In the quantitative variables, the arithmetic mean and the standard deviation will be calculated (variables that do not follow a normal distribution according to the Kolmogorov-Smirnov test will be described with median, minimum, maximum and interquartile range), and the qualitative ones will be expressed as percentages and your 95% confidence intervals.

The analysis of the primary objective, the proportion of incomplete polypectomies in both groups will be compared by means of the z test of homogeneity without using the correction of Yates.

The confidence interval of the difference between the two groups will also be estimated. The analysis will be carried out by intention to treat, regardless of the type of polypectomy performed and per protocol (assigning the lesions assigned to the group Cold that are extirpated with hot snare to the Hot group). To evaluate possible confounding factors (endoscopist, nurse, snare type, location ...), the STATA confound user command will be used, defining as a significant change that which conditions a change in the odds ratio greater than 10% with respect to the one obtained with the complete model. In case several models do not present differences greater than 10%, the most parsimonious will be chosen.

Within the secondary objectives, the proportion of complications in both groups will be verified by the de2 test. To evaluate the factors associated with incomplete polypectomies and those associated with failed cold polypectomy, multivariate logistic regression techniques will be used.

Polypectomy With Hot vs Cold Snare in Small Colonic Lesions

Number of patients with polypoid tissue at the base of polypectomy

Hospital del Río Hortega

Principal investigator

Colorectal Neoplasms

Intestinal Diseases

Colonic Diseases

Gastrointestinal Neoplasms

Intestinal Neoplasms

Digestive System Neoplasms

Rectal Diseases

Antipyretics

Anti-Inflammatory Agents

Antirheumatic Agents

Fibrinolytic Agents

Analgesics

Platelet Aggregation Inhibitors

Aspirin

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Cyclooxygenase Inhibitors

Enzyme Inhibitors

Patients with at least one large polyps taking aspirin in dose 75 mg daily for 21 days (7 days before and 14 days after polypectomy)

Patients with at least one large polyps taking placebo daily for 21 days (7 days before and 14 days after polypectomy)

Usage or withdrawal of aspirin (75mg daily per os) 7 days before and 14 days after polypectomy

Aspirin (ASA)

Placebo

Kaminski F Michal, MD

Pisera Malgorzata, MSc

Regula Jaroslaw, MD PhD

The risk of bleeding after polypectomy of large colorectal polyps in patients taking aspirin is uncertain. This is a randomized, multi-center, placebo-controlled, double-blind study to compare the risk of significant bleeding after endoscopic polypectomy of large (\>=10mm) colorectal polyps in patients continuing or discontinuing on daily acetylsalicylic acid (ASA) use. Eligible patients will be randomly assigned in a 1:1 ratio to a group taking 75mg daily ASA or placebo 7 days before and 14 days following polypectomy. The primary endpoint of the study is bleeding within 30 days from colorectal polypectomy. The secondary endpoints are composite cardiovascular events occurring between the date of randomization and 30 days after polypectomy.

Patients chronically taking aspirin (in prophylaxis doses 75-325 mg), with a diagnosis of colorectal polyps ≥ 10 mm in diameter will be enrolled on a routine polypectomy under hospitalization. Meeting the inclusion criteria, after informed consent and a cardiologist consent the patient will receive aspirin/placebo, and The Patient Diary to fill (Visit 1). The patient will be admitted to the Study Center in 6-7 days taking on the aspirin/placebo and prepared for the study (Visit 2). Patient will be under the care of a physician after polypectomy by a minimum of 6 hours. 14 days after polypectomy will be the first control visit, during which the physician will take back patient diary and pack treatment (Visit 3). 30 days after polypectomy will be the second control visit by phone (Visit 4). Patients will be monitored by looking at the end points.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Thalidomide Reduces Arteriovenous Malformation Related Gastrointestinal Bleeding	NCT00389935	Arteriovenous M... Hereditary Hemo... Hematochezia Melena	Thalidomide	18 Years -	Northport Veterans Affairs Medical Center
Same-session MR-only Simulation and Treatment With MRI-guided Adaptive Palliative RadioTherapy	NCT03824366	Malignancy Metastasis Hemoptysis Gastrointestina... Pelvic Bleeding Superior Vena C... Mediastinal Dis...	Volumetric MR i... Radiation thera...	18 Years -	Washington University School of Medicine
Comprehensive HHT Outcomes Registry of the United States (CHORUS)	NCT06259292	Hereditary Hemo... Arteriovenous M... Telangiectasia Epistaxis GastroIntestina... Cerebral Arteri... Vascular Malfor...		-	Cure HHT
Polypectomy With Hot vs Cold Snare in Small Colonic Lesions	NCT03783156	Polyp of Colon Gastrointestina... Colonic Adenoma	hot snare cold snare	18 Years -	Hospital del Río Hortega
The Risk of Bleeding After Removal of Large Colorectal Polyps in Patients Taking Aspirin	NCT01549418	Gastrointestina...	Aspirin (ASA) Placebo	40 Years -	Maria Sklodowska-Curie National Research Institute of Oncology
Comprehensive HHT Outcomes Registry of the United States (CHORUS)	NCT06259292	Hereditary Hemo... Arteriovenous M... Telangiectasia Epistaxis GastroIntestina... Cerebral Arteri... Vascular Malfor...		-	Cure HHT
Thalidomide Reduces Arteriovenous Malformation Related Gastrointestinal Bleeding	NCT00389935	Arteriovenous M... Hereditary Hemo... Hematochezia Melena	Thalidomide	18 Years -	Northport Veterans Affairs Medical Center

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