Clinical trials: Diagnostic Assay Development
Myelofibrosis (MF)
A New Diagnostic Algorithm to Non-invasively Track Fibrotic Changes in Myeloproliferative Neoplasms Based on C-C Chemokine Receptor 2 Detection. From Flow Cytometry to the Development of Targeted Positron Emission Tomography Molecular Imaging. Pre-clinical Studies and First In-human Proof of Concept
Chronic "Philadelphia-negative" myeloproliferative syndromes are chronic blood disorders. They include essential thrombocythemia, polycythemia vera, and myelofibrosis.
- Trial name
- GR-MPN (NCT07419178)
- Testing
- Diagnosis of MPN subtypes
- Where
- Italy
- Volunteers
- 265 people
- Sponsor
- Azienda Ospedaliero-Universitaria di Parma
Healthy Volunteers, Syphilis Serologic Assay Development
Blood Donation Study for ALPCO Syphilis-T and Syphilis-NT Assay Development
This prospective, single-center study will collect blood from approximately 50 adult volunteers aged 22 years or older. Participants will provide informed consent, complete an eligibility review, and undergo one blood draw of…
- Conditions
- Healthy Volunteers, Syphilis Serologic Assay Development, Blood Specimen Collection, Diagnostic Assay Development
- Trial name
- NCT07830550
- Testing
- ALPCO Syphilis-T, ALPCO Syphilis-NT CLIA Kits
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- American Laboratory Products Company
Acromegaly, Growth Hormone Deficiency
Inter-Assay Growth Hormone and IGF-I Variability
The purpose of this study is to demonstrate the degree of variability in commercially available assays for Growth Hormone measurement in the context of clinical decision making for Growth Hormone (GH) deficiency and Acromegaly…
- Trial name
- NCT00638287
- Volunteers
- 171 people, healthy volunteers welcome
- Sponsor
- Cedars-Sinai Medical Center
Tuberculosis Infection
Development of Automated Molecular Diagnostic Platform for Tuberculosis Diagnosis (New Assay TB)
It is intended for patients who have been admitted to the outpatient or emergency room or are hospitalized For patients who diagnose pulmonary tuberculosis or extrapulmonary tuberculosis using Xpert TB/RIF, additionally, diagnose…
- Trial name
- New Assay TB (NCT04988984)
- Where
- South Korea
- Volunteers
- 400 people
- Sponsor
- Asan Medical Center
Mucorales Infection, Mucormycosis
Biomarkers for Invasive Mucormycosis
Mucormycosis (MM) is one of the main invasive fungal infection (IFI), and is determined by filamentous fungi belonging to the order of Mucorales, with a mortality rate ranging from 20 to 60% according to localization.
- Trial name
- BIM (NCT05406037)
- Testing
- Venous sample
- Where
- France
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- University Hospital, Lille
Copy Number Variations
Development of a NIPTT for Detecting Copy Number Variations
To collect whole blood samples from pregnant women for the purpose of developing, optimizing and evaluating laboratory-developed noninvasive prenatal test (NIPT) for the detection of fetal chromosomal abnormalities of interest…
- Trial name
- NCT04774640
- Testing
- MaterniT GENOME
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Sequenom, Inc.
Pancreatic Cancer, Advanced or Metastatic
Signature Development and Validation Protocol for an Epigenetic Assay in Diagnosing Pancreatic Cancer
The purpose of this research study is to test a new process for diagnosing pancreatic cancer by examining changes to your DNA that can be detected from a blood test.
- Trial name
- NCT07528430
- Where
- United States
- Volunteers
- 450 people
- Sponsor
- University of Maryland, Baltimore
Healthy, Fungal Infections
Interest of Real-time Polymerase Chain Reaction (PCR) in the Diagnosis of Fungal Infections
Invasive fungal infections have a major impact on the morbidity and mortality of immunocompromised patients, including patients with hematological malignancies, neutropenic patients, human immunodeficiency virus infected…
- Trial name
- NCT00876096
- Testing
- Catch of blood then PCR
- Where
- 4 sites in France
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Centre Hospitalier Universitaire de Nice
Tuberculosis
Development of Molecular Diagnostic Platform for Tuberculosis
This study evaluates new technique for diagnosis of tuberculosis. Among patients who are suspected with tuberculosis, participants will be tested conventional method including Xpert TB/RIF assay, and new diagnostic technique…
- Trial name
- NCT04734236
- Testing
- New technique vs Xpert
- Where
- South Korea
- Volunteers
- 200 people
- Sponsor
- Asan Medical Center
Colorectal Cancer, Adenoma Colon Polyp
Triple Assay of Rectal Mucus in the Diagnosis of Colorectal Cancer
Development of a multiomics assay for use on OriColTM sampled rectal mucus for detection of cancer and significant polyps in symptomatic patients on the Colorectal Urgent Suspected Cancer pathway.
- Trial name
- TRIOMIC (NCT06649123)
- Testing
- Oricol Test
- Where
- United Kingdom
- Volunteers
- 6,600 people
- Sponsor
- Origin Sciences
New Coronavirus
Development of a Simple, Fast and Portable Recombinase Aided Amplification Assay for 2019-nCoV
In late December 2019, several local health facilities reported clusters of patients with pneumonia of unknown cause that were epidemiologically linked to a seafood and wet animal wholesale market in Wuhan, Hubei Province, China.
- Trial name
- NCT04245631
- Testing
- Recombinase aided amplification (RAA) assay
- Where
- China
- Volunteers
- 50 people
- Sponsor
- Beijing Ditan Hospital
Preeclampsia
Development of a Next Generation Sequencing (NGS) -Based Assay to Detect Preeclampsia Molecular Markers
Sample Collection Study
- Trial name
- NCT02808494
- Where
- 10 sites in United States
- Volunteers
- 242 people
- Sponsor
- Illumina, Inc.
Lung Cancer, Lung Cancer Screening
Signature Development and Validation Protocol for an Epigenetic Assay in Diagnosing Lung Cancer
The purpose of this research study is to test a new process for diagnosing lung cancer by examining changes to your DNA that can be detected from a blood test.
- Conditions
- Lung Cancer, Lung Cancer Screening, Healthy Volunteers (HV), Unhealthy Volunteers
- Trial name
- NCT07008664
- Testing
- Epigenetic Signature Assay
- Where
- United States
- Volunteers
- 750 people, healthy volunteers welcome
- Sponsor
- University of Maryland, Baltimore
Pneumonia, Acute Pyelonephritis
NGS-Based Assay of Blood Samples of Sepsis Patients for Rapid Bacterial Identification
Rapid detection of microorganisms is a promising approach towards early administration of appropriate antibiotics for sepsis. This study aims to investigate the potential of a new NGS platform for the rapid diagnosis of…
- Conditions
- Pneumonia, Acute Pyelonephritis, Bacteremia, Biliary Tract Infection
- Trial name
- BIOARTE (NCT06141395)
- Testing
- NGS-based assay for bacterial identification
- Where
- 4 sites in Greece
- Volunteers
- 100 people
- Sponsor
- Hellenic Institute for the Study of Sepsis
Tuberculosis
Development of a Rapid and Accurate Diagnostic Assay for Tuberculosis
This study evaluates new technique for diagnosis of tuberculosis. Among patients who are suspected with tuberculosis, participants will be tested conventional method including Xpert TB/RIF assay, and new diagnostic technique…
- Trial name
- NCT03423550
- Where
- South Korea
- Volunteers
- 300 people
- Sponsor
- Asan Medical Center
Myelodysplastic Syndromes
Development and Prospective Validation of a Standardized Flow Cytometric Assay of Peripheral Blood Neutrophil Myeloperoxidase Expression for Ruling Out Myelodysplastic Syndromes.
Myelodysplastic syndromes (MDS) comprise a heterogeneous group of clonal bone marrow neoplasms that predominate in the elderly, with a median age at diagnosis of 70 years.
- Trial name
- MPO-MDS-Develp (NCT04399018)
- Testing
- Diagnostic Test: Flow cytometry analysis of neutrophil myeloperoxidase expression
- Where
- France
- Volunteers
- 103 people
- Sponsor
- University Hospital, Grenoble
Lung Cancer, Surgery
Development and Clinical Validation of Early-stage Lung Cancer Prognostic Kit
Lung cancer is the leading cause of cancer mortality worldwide in spite of the advanced progresses in medication and low-dose CT screening.
- Conditions
- Lung Cancer, Surgery, Recurrence
- Trial name
- NCT05557474
- Testing
- Early-stage lung cancer prognostic kit -- ELISA, Early-stage lung cancer prognostic kit -- IHC
- Where
- 2 sites in Taiwan
- Volunteers
- 236 people
- Sponsor
- Chung Shan Medical University
Ebola Virus Disease, Marburg Virus Disease
Evaluation of Safety, Tolerability and Immune Responses of Ebola-S and Marburg Vaccines in Healthy Adults
Primary Objective: To evaluate the safety and tolerability of cAd3-EBO-S and cAd3 Marburg vaccines when administered Intramuscular (IM) at a dose of 1 x 10^11 particle units (PU) to healthy adults.
- Trial name
- NCT04723602
- Testing
- cAd3-Marburg, cAd3-EBO-S
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Albert B. Sabin Vaccine Institute
Breast Cancer (Locally Advanced or Metastatic), Healthy Volunteers (HV)
Signature Development and Validation Protocol for an Epigenetic Assay in Diagnosing Breast Cancer
The purpose of this research study is to test a new process for diagnosing breast cancer by examining changes to your DNA that can be detected from a blood test.
- Conditions
- Breast Cancer (Locally Advanced or Metastatic), Healthy Volunteers (HV), Unhealthy Volunteers, Breast Cancer Screening
- Trial name
- NCT07374796
- Testing
- Epigenetic Assay
- Where
- United States
- Volunteers
- 450 people, healthy volunteers welcome
- Sponsor
- University of Maryland, Baltimore
Non-hematologic Cancer
Specimen Collection From Patients With Non-Hematologic Cancer for Use in Development of a Liquid Biopsy Assay
This specimen collection is designed to obtain whole blood and tumor tissue from subjects diagnosed with cancer for the purpose of the development of a noninvasive liquid biopsy assay using next generation sequencing (NGS).
- Trial name
- NCT02586389
- Where
- United States
- Volunteers
- 3,000 people
- Sponsor
- Sequenom, Inc.