Clinical trials: Diagnostic Tests
Influenza Type A, Influenza Type B
Influenza A+B Test Kit Performance Study
Prospective clinical study on the performance of an Influenza A+B rapid test kit. The main goal is to establish the sensitivity and specificity (i.e. how accurate the test is) when compared to a gold standard.
- Trial name
- NCT03895268
- Testing
- ALiA Analyser, Influenza A+B Test Kit
- Where
- Hong Kong
- Volunteers
- 600 people
- Sponsor
- Sanwa BioTech Limited
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
Colorectal Cancer (Diagnosis)
Colorectal Lesion Evaluation and Appropriate Resolution (CLEAR) Study
The primary objective of this study is to evaluate a blood-based screening test for Colorectal Cancer (CRC).
- Trial name
- CLEAR (NCT07479381)
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Harbinger Health
Adenocarcinoma, Ovarian Neoplasms
Testing Drug Sensitivity of Ovarian, Fallopian and Primary Peritoneal Adenocarcinomas
2.0 Study Objectives: 2.1 To evaluate the ability of the MiCK assay to predict the outcome of chemotherapy of cancer patients for first-line treatment.
- Conditions
- Adenocarcinoma, Ovarian Neoplasms, Fallopian Tube Neoplasms, Peritoneal Neoplasms
- Trial name
- NCT00443196
- Testing
- MiCK Assay
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- Pierian Biosciences
Diagnosis of Adult Growth Hormone Deficiency (AGDH)
Investigation of a New, Oral Growth Hormone Secretagogue, AEZS-130 as a Growth Hormone Stimulation Test.
The diagnosis of growth hormone deficiency (GHD) in adults is established by laboratory testing in patients with an appropriate clinical history of hypothalamic pituitary disease.
- Trial name
- NCT00448747
- Testing
- AEZS-130 (formerly ARD-07), L-ARG+GHRH
- Where
- 13 sites in United States
- Volunteers
- 101 people, healthy volunteers welcome
- Sponsor
- AEterna Zentaris
Malaria Diagnosis, Malaria,Falciparum
Evaluation of the Performance of a hsRDT Versus cRDT in Reactive Case Detection of Malaria Infections
A systematic review assessing the role, appropriateness and benefits of the active case detection strategy, both proactive and reactive, in low malaria transmission settings.
- Trial name
- NCT03511443
- Testing
- hsRDT
- Where
- Burma
- Volunteers
- 1,980 people, healthy volunteers welcome
- Sponsor
- University Research Co, LLC
Diabetic Foot Ulcer, Venous Leg Ulcer
DETEC® pH Point of Care Wound Diagnostic Test
The purpose of this study is to determine the relationship between wound alkalinity and the non-healing status of chronic ulcer wounds.
- Conditions
- Diabetic Foot Ulcer, Venous Leg Ulcer, Pressure Ulcer, Wound, Non-Healed
- Trial name
- NCT04614038
- Testing
- DETEC® pH
- Where
- 2 sites in United States
- Volunteers
- 450 people
- Sponsor
- Progenitec Inc.
Respiratory Tract Infections (RTI), Influenza-like Illness
Clinical Assessment of Respiratory Events for Kids: Integrating Diagnostics and Stewardship
This study, called Care4Kids, aims to improve the management of respiratory infections in children visiting emergency departments.
- Conditions
- Respiratory Tract Infections (RTI), Influenza-like Illness, Children
- Trial name
- CARE4KIDS (NCT07453914)
- Testing
- SPOTFIRE R
- Where
- 3 sites in France, Greece and 1 more
- Volunteers
- 720 people
- Sponsor
- BioMérieux
Infectious Diseases
Sensitivity Study of Diagnostic for Detection of Chagas Infection
This study is a multi-site trial assessing the sensitivity of Chagas Detect™ Plus rapid test versus standard reference tests (e.g. IFA, IHA, RIPA) for Chagas diagnosis.
- Trial name
- NCT02134548
- Where
- 2 sites in Bolivia, Chile
- Volunteers
- 1,601 people
- Sponsor
- InBios International, Inc.
Early Cancer Detection
Detecting Cancers Earlier Through Elective Plasma-based CancerSEEK Testing
This is a prospective, observational study of 1,000 subjects with known or suspected cancer and 2,000 subjects with no known cancer.
- Trial name
- ASCEND (NCT04213326)
- Where
- 14 sites in United States
- Volunteers
- 6,400 people, healthy volunteers welcome
- Sponsor
- Exact Sciences Corporation
Syphilis Infection, Treponema Pallidum Infection
NOWDx Test for the Diagnosis of Syphilis
This study is designed to compare the performance of the NOWDx Syphilis Test to a currently marketed device. The intent is to show the rapid test device is comparable to the currently marketed device.
- Trial name
- NCT05063344
- Testing
- Diagnostic Test: NOWDx Syphilis Test
- Where
- 6 sites in United States
- Volunteers
- 1,535 people
- Sponsor
- NOWDiagnostics, Inc.
Communicable Disease, COVID-19
COVID-19 Diagnostic Self-testing Using Virtual Point-of-care
The goal of the research is to assess candidate COVID-19 rapid diagnostic tests (e.g. immunodiagnostic antibody tests, like Cellex qSARS-CoV-2 IgG/IgM Rapid Test, or antigen tests, like Turklab Test-It COVID-19 Home Test, AllBio…
- Conditions
- Communicable Disease, COVID-19, Sars-CoV2, Infectious Disease
- Trial name
- NCT04348864
- Testing
- COVID-19 Antigen/Antibody Rapid Testing, mobile device image capture and telemedicine support, Telemedicine
- Where
- United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Neuroganics LLC
Bone and Joint Prosthetic Infections
BJI Inoplex 2 : Test for Diagnosis of Prosthetic Infections
A national, prospective, open-label, non-interventional, multicentre, controlled study designed to evaluate a diagnostic method in patients undergoing hip, knee or shoulder prosthetic removal regardless of whether or not…
- Trial name
- NCT02222792
- Where
- 2 sites in France
- Volunteers
- 540 people
- Sponsor
- Diaxonhit
Birth Asphyxia
Asphyxia Associated Metabolite Biomarker Investigation 2
Follow-up of participants of AAMBI1 study at age of at least 2 years. AAMBI1(ClinicalTrials.gov ID: NCT03354208): Verification of biomarkers in a human population for their ability to diagnose the severity of neonatal asphyxia.
- Trial name
- AAMBI2 (NCT04714502)
- Where
- 4 sites in Turkey (Türkiye)
- Volunteers
- 144 people
- Sponsor
- InfanDx AG
Acute Myocardial Infarction
SpinChip Hs-cTnI Clinical Diagnostic Performance
During a heart attack, the protein troponin I is released from the heart muscle into the bloodstream. Measurements of cardiac troponin in blood are used as an aid in the diagnosis of heart attack.
- Trial name
- HEAT-4 (NCT06499519)
- Testing
- SpinChip hs-cTnI
- Where
- 9 sites in Denmark, Germany and 4 more
- Volunteers
- 1,551 people
- Sponsor
- SpinChip Diagnostics ASA
Cervical Cytology, PAP
Techcyte SureView Cervical Cytology System Clinical Validation Study
The clinical study is a multi-center, retrospective, blinded, matched-pair, two-arm clinical study in which one test assessment and a control assessment of liquid-based cytology (LBC) pap tests are performed and compared to a…
- Trial name
- NCT06767111
- Testing
- Digital cervical cytology slide imaging system with artificial intelligence (AI) algorithm in vitro diagnostic (IVD) device
- Where
- United States
- Volunteers
- 4,596 people, healthy volunteers welcome
- Sponsor
- Techcyte, Inc.
Diagnostic Test
AQT90 FLEX NTproBNP2 Test Kit Method Comparison Study
The purpose of this study is to verify performance claims for method comparison for the NTproBNP2 Test Kit on the AQT90 FLEX analyzer in whole blood (WB) and plasma (PL).
- Trial name
- NCT06693050
- Where
- 3 sites in Spain
- Volunteers
- 153 people
- Sponsor
- Radiometer Medical ApS
Colo-rectal Cancer, Cancer Colon
AI-EMERGE: Development and Validation of a Multi-analyte, Blood-based Colorectal Cancer Screening Test
Freenome is using a type of artificial intelligence, called machine learning, to identify patterns of cell-free biomarkers in blood to detect cancer early.
- Conditions
- Colo-rectal Cancer, Cancer Colon, Cancer, Rectum, Neoplasms,Colorectal
- Trial name
- NCT03688906
- Where
- 30 sites in United States, Canada
- Volunteers
- 3,275 people, healthy volunteers welcome
- Sponsor
- Freenome Holdings Inc.
Cancer
Prospective Study to Assess a Diagnostic Aid for Cancer
The primary objective of this study is to establish the performance of two blood-based diagnostic aid test for cancer detection in individuals presenting with symptoms, signs, or findings suggestive of cancer.
- Trial name
- PROCARES (NCT07046260)
- Testing
- Blood sample collection
- Where
- 42 sites in United States
- Volunteers
- 2,450 people
- Sponsor
- Harbinger Health
Paludism
Evaluation of the STANDARD G6PD Rapid Test for Assaying the Enzymatic Activity of G6PD in French Guiana
In French Guiana, malaria is endemic and two species predominate: P. falciparum and P. vivax. The treatments against Plasmodium vivax malaria are: nivaquine for 3 days against circulating blood parasites and primaquine for 14…
- Trial name
- G6PD facile (NCT04698980)
- Testing
- blood samples (venous and capillary at the fingertip)
- Where
- French Guiana
- Volunteers
- 150 people
- Sponsor
- Institut Pasteur