Clinical trials: Diagnostic Tests
Endometrial Cancer
Evaluation of MCM5 in Postmenopausal Bleeding Patients
The objective of this multi-centre, prospective study, is to evaluate the performance of a urine MCM5 ELISA test (ADXGYNAE) in the detection of endometrial cancer in patients with postmenopausal bleeding.
- Trial name
- NCT05287048
- Testing
- MCM5 ELISA
- Where
- United Kingdom
- Volunteers
- 2,000 people
- Sponsor
- Arquer Diagnostics Ltd
Asthma, Mastocytosis
Mast Cell Activation Test in Allergic Disease
Activation of mast cells in the immune system is known to cause allergic reactions sometimes with severe systemic symptoms. The investigators have recently developed a blood-based mast cell activation diagnostic test in which…
- Conditions
- Asthma, Mastocytosis, Mast Cell Activation Syndrome, Food Allergy
- Trial name
- NCT03406325
- Where
- Hong Kong
- Volunteers
- 19 people
- Sponsor
- Hong Kong Sanatorium & Hospital
COVID-19, Asymptomatic COVID-19
A Clinical Evaluation of Proof Diagnostics Test System Including the Proof Diagnostics Reader and COVID-19 Test
To determine the accuracy of Proof Diagnostics COVID-19 Test in the intended, symptomatic and suspected/at-risk asymptomatic population and point-of-care use as compared to a standard molecular comparator, Quidel Lyra SARS-CoV-2…
- Trial name
- NCT05331976
- Testing
- Proof Lab Test System
- Where
- 3 sites in United States
- Volunteers
- 276 people
- Sponsor
- Proof Diagnostics
Pulmonary Arterial Hypertension
Assessing the Utility of Submaximal CPET in Treatment Management of PAH
Pulmonary hypertension (PH) is associated with worsening breathlessness and exercise capacity, right-heart failure, and adverse outcomes including increased mortality.
- Trial name
- NCT05977933
- Testing
- Shape II CPET
- Where
- 6 sites in United States
- Volunteers
- 550 people
- Sponsor
- Shape Medical Systems, Inc.
Trisomy 13, Trisomy 18
Multiple Gestation Study
The objectives of the clinical study are to demonstrate the accuracy of our new NATUS diagnostic method to determine the genetic health of the developing fetuses in a multiple gestation pregnancy from a maternal blood sample.
- Conditions
- Trisomy 13, Trisomy 18, Trisomy 21, Sex Chromosome Abnormalities
- Trial name
- NCT02278536
- Where
- 8 sites in United States, India and 1 more
- Volunteers
- 354 people, healthy volunteers welcome
- Sponsor
- Natera, Inc.
Infertility
Correlating Time-Lapse Parameters With aCGH Testing in IVF Treatment (aCGH Study)
The purpose of this research study protocol is to collect imaging data on embryos followed to blastocyst stage (Day 5-6) and correlate Eeva parameters with array - Comparative Genomic Hybridization (aCGH) results and ongoing…
- Trial name
- NCT02141685
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Progyny, Inc.
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.
Children18-72 Months With a Suspicion Autistic Disorder
Extension for Community Healthcare Outcomes (ECHO) Autism Diagnostic Study in Primary Care Setting
This is a collaborative study that will provide a comprehensive source of observational data that can be used to obtain real world evidence of ASD.
- Trial name
- NCT05223374
- Testing
- Canvas Dx
- Where
- United States
- Volunteers
- 110 people
- Sponsor
- Cognoa, Inc.
Diagnostic Techniques and Procedures, Clinical Laboratory Techniques
Clinical Validation of an Artificial Intelligence System for the Interpretation of Laboratory Test Results Combined With a Structured Medical History
This study evaluates a certified artificial intelligence (AI) based software system that automatically interprets laboratory test results in combination with a structured, dynamically generated medical history questionnaire.
- Conditions
- Diagnostic Techniques and Procedures, Clinical Laboratory Techniques, Triage
- Trial name
- LTC-VALID (NCT07810491)
- Testing
- AI-based laboratory result interpretation software
- Where
- 2 sites in Poland
- Volunteers
- 899 people
- Sponsor
- Labplus Sp. z o.o.
Central Nervous System Infections, Pseudotumor Cerebri
A Study to Test Performance of Needle Placements for Neuraxial Procedures Using Tactile Imaging vs Control
This study will compare the VerTouch device to the conventional palpation technique for performing diagnostic and therapeutic neuraxial procedures.
- Conditions
- Central Nervous System Infections, Pseudotumor Cerebri, Neurological Disorder, Cancer
- Trial name
- NCT04796935
- Testing
- Tactile Imaging (VerTouch), Control (palpation)
- Where
- 3 sites in United States
- Volunteers
- 95 people
- Sponsor
- IntuiTap Medical, Inc
Streptococcus Pyogenes Infection, Pharyngitis
Clinical Performance of the Checkable Medical At-Home Strep A Test
The Checkable Medical At-Home Strep A Test is a rapid chromatographic immunoassay for the qualitative detection of Group A Strep (GAS) antigens from throat swabs.
- Conditions
- Streptococcus Pyogenes Infection, Pharyngitis, Respiratory Tract Infections
- Trial name
- NCT05107362
- Testing
- untrained lay user performs investigational diagnostic test
- Where
- 22 sites in United States
- Volunteers
- 1,347 people
- Sponsor
- Checkable Medical Inc
NAFLD, NASH - Nonalcoholic Steatohepatitis
Development and Validation of a Multi-target, Blood-based NAFLD Diagnosis Test
Multi-omics approach was used to identify patterns of serological biomarkers to diagnose NAFLD. The purpose of this study is to develop and validate a blood-based assay to diagnose NAFLD by collecting blood sample from healthy…
- Trial name
- NCT05108415
- Volunteers
- 1,500 people, healthy volunteers welcome
- Sponsor
- HBI Solutions Inc.
Pancreatic Cancer Stage I, Pancreatic Cancer Stage II
Clinical Validation of Immunovia Next-Generation Blood Biomarker Test to Detect Early-Stage Pancreatic Cancer
This is a case-control study to clinically validate the performance of a protein biomarker test to differentiate Stage I and Stage II pancreatic ductal adenocarcinoma (PDAC) patient samples from samples acquired from control…
- Conditions
- Pancreatic Cancer Stage I, Pancreatic Cancer Stage II, Cancer Diagnosis, PDAC - Pancreatic Ductal Adenocarcinoma
- Trial name
- CLARITI (NCT06947382)
- Where
- 15 sites in United States, Canada and 2 more
- Volunteers
- 1,066 people, healthy volunteers welcome
- Sponsor
- Immunovia, Inc.
Breast Cancer
Test of Digital Breast Tomosynthesis vs. Regular Mammography in Detecting Breast Cancer in Women Undergoing Diagnostic Mammography
Comparison of the ability of DBT and FFDM to detect breast cancer.
- Trial name
- NCT00535327
- Volunteers
- 220 people
- Sponsor
- GE Healthcare
Claustrophobia, Complication of Diagnostic Procedure
Reduction of Claustrophobia and Patient Motion After Training of MRI Personnel in Comfort TalkTM
Annually, an estimated 700,000 patients do not complete their scheduled MRI scans because of claustrophobia or inability to hold still.
- Trial name
- NCT01563198
- Testing
- Comfort Talk®
- Where
- 4 sites in United States
- Volunteers
- 97,712 people
- Sponsor
- Hypnalgesics, LLC
Acute Coronary Syndrome
Clinical Study to Validate the Use of a New Point of Care Troponin I Test
This trial is designed as a prospective, multi-center, observational study of "all-comers" eligible adult subjects presenting to participating emergency departments with symptoms suggestive of acute coronary syndrome (ACS)
- Trial name
- NCT02620397
- Where
- 14 sites in United States
- Volunteers
- 1,500 people
- Sponsor
- Trinity Biotech
Food Hypersensitivity
Food Allergy Challenge Diagnostic Study
The objective of this study is to correlate various diagnostic measurements taken during an escalating dose oral food challenge to the subject's response.
- Trial name
- NCT02606721
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- ORA, Inc.
Menorrhagia
A Study Run at Multiple Study Sites to Test Whether the SAMANTA Questionnaire That is Used to Diagnose Heavy Menstrual Bleeding (HMB), Can Also be Used to Assess Changes of Severity of HMB in Women With HMB Who Are Treated During 12 Months With a Chronic Hormonal Treatment
A study run at multiple study sites in Spain to test whether the SAMANTA questionnaire that is used to diagnose heavy menstrual bleeding (HMB), can also be used to assess changes of severity of HMB in women with HMB who are…
- Trial name
- SAMIRA (NCT03751800)
- Testing
- Chronic hormonal treatment
- Where
- Spain
- Volunteers
- 422 people
- Sponsor
- Bayer
AKI, Contrast-induced Nephropathy
Establishing Clinical Utility of a New Diagnostic Test in Patients Undergoing Cardiac Catheterization
This study will collect high-quality randomized controlled data across the U.S. from practicing cardiologists performing invasive/interventional procedures and determine how they currently manage patients at risk for CIN and how…
- Trial name
- NCT04266834
- Testing
- Experimental Arm
- Where
- United States
- Volunteers
- 157 people, healthy volunteers welcome
- Sponsor
- Qure Healthcare, LLC
Infection, Infections, Bacterial
Microbial Cell-free Metagenomic Sequencing for Suspected Infections in Adult Immunocompromised Outpatients
This clinical trial is designed to evaluate if adding the Karius Spectrum™ plasma test to usual care diagnostic tests, compared to usual care testing alone, among immunocompromised participants presenting with suspected infection…
- Conditions
- Infection, Infections, Bacterial, Infections, Fungal, Infection Viral
- Trial name
- OPTIMUM (NCT07110636)
- Testing
- Metagenomic plasma-based test for agnostic pathogen detection
- Where
- 6 sites in United States
- Volunteers
- 2,000 people
- Sponsor
- Karius, Inc.