Heart and Blood Diseases

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Thrombosis

Venous Thrombosis

Lung Diseases

Pulmonary Embolism

Embolism

Thromboembolism

Respiration Disorders

Respiratory Tract Diseases

Embolism and Thrombosis

Vascular Diseases

All Drugs and Chemicals

Hematinics

Bone Density Conservation Agents

Fluorodeoxyglucose F18

Calcium

Liver Extracts

Calcium, Dietary

Complete clinical history, along with routine physical, analytical examination (creatinine, sodium, potassium, red series, white series, liver and calcium profile) and chest x-ray.

Limited screening plus positron emission tomography / computed tomography with 18 FDG (18FDG PET-CT).

The performance of the 18 FDG PET-CT will require fasting of at least 6 hours, and the glycemia will have to be lower than 126 mg / dL before the injection of 3-5 MBq / kg of 18FDG. Intravenous injection will follow a period of approximately 60 minutes in a quiet room.

Computed tomography (CT) will be performed from the middle of the forehead to the feet with normal and shallow breathing using a low dose adjustment Iodinated contrast will not be administered intravenously.

Fludeoxyglucose 18F

Luis Jara Palomares, MD/PhD

Clara M Rosso Fernández, MD/PhD

Juan José López Núñez, MD

Gloria de la Red Bellvis, MD

Luis Jara-Palomares, MD

Jesús Aibar Gallizo, MD

Marina Suarez Pinera, MD

Diego Agustin Rodríguez, MD

Fátima del Molino Sanz, MD

Carmen Díaz Pedroche, MD

Alicia Lorenzo Hernández, MD

Vladimir Salazar Rosa, MD

Open and multicenter randomized clinical trial (1:1) comparing limited screening with extended screening with the performance of Positron emission tomography-computed tomography (PET-CT) scan in the search for neoplasms in patients with unprovoked venous thromboembolic disease at high risk of developing cancer at follow-up.

Introduction: Cancer screening in patients with unprovoked venous thromboembolic disease (VTE) is controversial. In the last years, a score has been developed that selects patients at high risk of developing cancer during follow-up.

Objective: To estimate the impact of an active cancer search strategy using 18-fluordesoxiglucose (FDG) PET-CT in unprovoked VTE with high-risk to develop cancer.

Specific Objectives: 1) Number of neoplasms diagnosed in the screening process: 2) number of neoplasms diagnosed at an early stage, 3) impact on survival of the strategy; and 4) impact on the quality of life.

Cancer will be considered from 30 days up to 12 months after the diagnosis of VTE.

Scope: 20 Spanish hospitals. Design: Open-label, multicentre Randomized clinical trial (1: 1) comparing the performance of PET-CT versus limited screening for cancer.

Population: Patients older than 18 years with unprovoked VTE at high risk of presenting cancer at follow-up (≥3 points in the score of Jara-Palomares et al., Chest 2017).

Follow-up: 12 months after VTE. Sample: The sample size calculated is 650 patients, to obtain a power of 80%, with a level of significance of 5%, and taking into account a 10% loss of follow-up.

Screening for Cancer in Patients With Unprovoked VTE

PET / CT Scan to Detect Cancer in Patients With Unprovoked Venous Thromboembolic Disease. Open Randomized Clinical Trial.

IPD to be shared with the center participants once the study is officially finished in the foreseen period of three years.

Estimate the impact of an active cancer search strategy using PET-CT in the number of neoplasms diagnosed in the screening process in patients with high-risk unprovoked thromboembolic disease.

Estimate the impact of an active cancer search strategy using PET-CT in the number of neoplasms diagnosed in early phase in the screening process in patients with high-risk unprovoked thromboembolic disease.

Estimate the impact of an active cancer search strategy using PET-CT in the overall survival in patients with high-risk unprovoked thromboembolic disease.

Estimate the impact of an active cancer search strategy using PET-CT in the quality of life evaluated with the scale EQ-5D in patients with high-risk unprovoked thromboembolic disease. The EQ-5D consists of 2 parts - the "Descriptive System" and the "Visual Analogue scale". The DS comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems.

The EQ VAS records the respondent's self-rated health on a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'. This information can be used as a quantitative measure of health as judged by the individual respondents.

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Immune System Diseases

Symptoms and General Pathology

Infections

Rare Diseases

Graft vs Host Disease

Syndrome

Bronchiolitis

Bronchiolitis Obliterans Syndrome

Bronchiolitis Obliterans

Pneumonia

Organizing Pneumonia

Bronchitis

Bronchial Diseases

Lung Diseases, Obstructive

Chronic Graft Versus Host Disease

Homologous Wasting Disease

Bronchiolitis Obliterans Organizing Pneumonia

Participants with a history of allo-HCT and diagnosis with oral chronic GvHD randomized to the treatment arm will be treated with oral photobiomodulation/PBM (via Thor LX2.3 system device) for 28 days

Photobiomodulation Therapy

Participants with a history of allo-HCT and diagnosis with oral chronic GvHD randomized to the placebo arm will be treated with a placebo sham device (via Thor LX2.3 sham device setting) for 28 days

Placebo sham device

Alina Markova, MD

Doris Ponce, MD

Jacqueline Mays, DDS, MHSc, PhD

Alina K Markova, MD

Alina K Markova, MD, PhD

Annie Im, MD

The purpose of this study is to find out whether photobiomodulation/PBM therapy using the Thor LX2.3 therapy system is a safe and effective treatment for oral Graft-Versus-Host Disease/GVHD.

This is a phase 2, double-blind, randomized (1:1 ratio) study

A Study of Photobiomodulation (PBM) Therapy in People With Oral Graft-Versus-Host Disease (GVHD) After Stem Cell Transplant

A Multi-Center, Phase II, Randomized Double-Blind Trial to Evaluate the Efficacy and Safety of Photobiomodulation for the Treatment of Oral Chronic Graft-Versus-Host Disease After Allogeneic Stem Cell Transplantation (the LIGHT Trial)

• 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.

To assess the primary objective, we will compare the treatment response rates, defined as the the proportion of oral GvHD allo-HCT patients who achieve a CR or a PR at Day 28, for the PBM and Placebo arms. The treatment response rate will be calculated within each study arm for all patients who completed at least one PBM or placebo treatment.

Memorial Sloan Kettering Cancer Center

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Screening for Cancer in Patients With Unprovoked VTE	NCT03937583	Venous Thromboe... Respiratory Dis... Pulmonary Disea... Deep Venous Thr... Pulmonary Embol... Screening Undefined	Fludeoxyglucose...	18 Years -	Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Screening for Cancer in Patients With Unprovoked VTE	NCT03937583	Venous Thromboe... Respiratory Dis... Pulmonary Disea... Deep Venous Thr... Pulmonary Embol... Screening Undefined	Fludeoxyglucose...	18 Years -	Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
A Study of Photobiomodulation (PBM) Therapy in People With Oral Graft-Versus-Host Disease (GVHD) After Stem Cell Transplant	NCT05675930	Graft-Versus-Ho... GVHD Undefined	Photobiomodulat... Placebo sham de...	4 Years -	Memorial Sloan Kettering Cancer Center

Spots Global Cancer Trial Database for undefined

Every month we try and update this database with for undefined cancer trials from around the world to help patients and their families find trials that might be right for them.
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Spots Global Cancer Trial Database for undefined

Every month we try and update this database with for undefined 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 undefined 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.