Clinical trials: Performance, Detection
Treponema Pallidum, Treponema Pallidum Infection
This Study Evaluates the ALPCO Syphilis-T and Syphilis-NT CLIA Kits for Detecting Syphilis Antibodies in Serum and Plasma. Samples From At-risk, HIV-positive, Pregnant, and Healthy Individuals Will Assess Assay Performance Versus Established Comparator Tests.
This study will evaluate the clinical performance of two investigational diagnostic kits developed by ALPCO: the Syphilis-T CLIA Kit and the Syphilis-NT CLIA Kit.
- Conditions
- Treponema Pallidum, Treponema Pallidum Infection, Syphilis Infection, Serum
- Trial name
- NCT07089836
- Testing
- ALPCO Syphilis-T, ALPCO Syphilis-NT CLIA Kits
- Where
- 6 sites in United States
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- American Laboratory Products Company
Helicobacter Pylori
Performances of a H. Pylori Stool PCR Test
Performance of a non-invasive test for the detection of Helicobacter pylori and its resistance to clarithromycin in stool by Real-Time PCR Amplidiag H. pylori + ClariR (Mobidiag).
- Trial name
- HEPYSTOOL (NCT03566004)
- Testing
- Stool specimen collection
- Where
- France
- Volunteers
- 1,200 people
- Sponsor
- Poitiers University Hospital
Artificial Intelligence, Lung Diseases
Retrospective Study of Carebot AI CXR Performance in Preclinical Practice
The purpose of this study is to describe the design, methodology and evaluation of the preclinical test of Carebot AI CXR software, and to provide evidence that the investigated medical device meets user requirements in…
- Conditions
- Artificial Intelligence, Lung Diseases, Pneumothorax, Pleural Effusion
- Trial name
- NCT05594485
- Testing
- Carebot AI CXR
- Where
- Czechia
- Volunteers
- 127 people
- Sponsor
- Carebot s.r.o.
Atrial Fibrillation
Clinical Performance of Withings Move ECG Software for Atrial Fibrillation Detection
Withings Move ECG watch is designed to record ECG and detect automatically atrial fibrillation. The aim of this study is to validate the performance of Move ECG watch to detect atrial fibrillation compared to a reference 12-lead…
- Trial name
- ECG-SW1 (NCT04493749)
- Testing
- ECG measurement
- Where
- 3 sites in France
- Volunteers
- 234 people
- Sponsor
- Withings
Cancer
PERformance of Multi-Cancer Early-detectIon Based on Various Biomarkers in fEmale BREAST Cancers, PERCEIVE-BREAST
This study is a retrospective and prospective study aimed to develop and validate the performance of multi-omics assays for early detection of female breast cancer.
- Trial name
- NCT06979921
- Testing
- Blood test
- Where
- 2 sites in China
- Volunteers
- 496 people
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
Tuberculosis, Pulmonary, Tuberculosis, Multidrug-Resistant
Xpert MTB/XDR Clinical Evaluation Trial
FIND and partners intend to address the need for a multi- and extensively drug-resistant tuberculosis (M/XDR-TB) diagnostic solution for patients in settings with a high burden of drug-resistant tuberculosis (DR-TB) though the…
- Trial name
- NCT03728725
- Testing
- Cepheid Gene Xpert MTB/XDR
- Where
- Moldova
- Volunteers
- 710 people, healthy volunteers welcome
- Sponsor
- Foundation for Innovative New Diagnostics, Switzerland
Severe Acute Malnutrition
Performance of Mid-Upper Arm Circumference for Detection of Severe Acute Malnutrition in Indonesian Under-Fives
WHO recommends 11.5 cm as a cut-off point of Mid-Upper Arm Circumference (MUAC) to detect and/or diagnose severe acute malnutrition (SAM) in under-five.
- Trial name
- NCT06545240
- Testing
- Mid-upper arm circumference
- Where
- 2 sites in Indonesia
- Volunteers
- 421 people, healthy volunteers welcome
- Sponsor
- Universitas Indonesia
Breast Cancer, Breast Neoplasms
Delphinus SoftVue™ ROC Reader Study
The purpose of this multi-reader, multi-case (MRMC) reader study is to evaluate reader performance when SoftVue™ automated breast ultrasound and screening mammography are combined, compared to screening mammography alone, in…
- Trial name
- DMT SV RRS1 (NCT03698942)
- Testing
- Reading of Automated Breast Ultrasound in conjunction with Screening Mammography
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Delphinus Medical Technologies, Inc.
Prostate Carcinoma
[18F]-rhPSMA PET-CT Imaging Performance in Patients With Prostate Cancer
This clinical trial evaluates [18F]-rh PSMA positron emission tomography (PET)-computed tomography (CT) imaging performance in patients with prostate cancer.
- Trial name
- NCT06580015
- Testing
- Computed Tomography, Flotufolastat F-18 Gallium, Medical Device Usage and Evaluation
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- City of Hope Medical Center
Nasopharyngeal Carcinoma
Diagnostic Accuracy of EBV C Promoter Methylation Kit in Nasopharyngeal Carcinoma
This clinical study aims to evaluate the diagnostic performance of a new Epstein-Barr virus (EBV) C promoter methylation detection kit.
- Trial name
- NCT06445088
- Testing
- VCA-IgA, EBNA1-IgA, and EBV-DNA, EBV C Promoter Methylation Detection in nasopharyngeal swab samples
- Where
- 5 sites in China
- Volunteers
- 908 people
- Sponsor
- Sun Yat-sen University
Early Detection of Cancer, Cancer
PATHFINDER 2: A Multi-Cancer Early Detection Study
This is a prospective, multi-center interventional study of the GRAIL multi-cancer early detection (MCED) test with return of test results for participants enrolled through healthcare systems in North America.
- Trial name
- NCT05155605
- Testing
- Multi-Cancer Early Detection Test
- Where
- 56 sites in United States, Canada
- Volunteers
- 35,883 people, healthy volunteers welcome
- Sponsor
- GRAIL, Inc.
Preeclampsia (PE)
Validation of the MaiRa Preeclampsia Test for Screening Early/Late Preeclampsia in First and Second Trimesters
Preeclampsia (PE) is a major obstetric complication with severe short- and long-term consequences for both mother and fetus. Early detection is critical to mitigate PE-related morbidity and mortality.
- Trial name
- iPregnostic (NCT06716242)
- Testing
- Peripheral blood collection
- Where
- 11 sites in Spain
- Volunteers
- 7,473 people
- Sponsor
- iPremom
STI
Comparing a Novel Point-of-care Cytokine Biomarker Lateral Flow Test With Nucleic Acid Amplification Tests for Detection of Sexually Transmitted Infections and Bacterial Vaginosis
1. To evaluate the performance of a lateral flow POC test, namely the Genital InFlammation Test (GIFT), for identifying women with inflammatory STIs and BV, who are at higher risk of HIV infection and reproductive complications…
- Trial name
- GIFT (NCT05723484)
- Testing
- GIFT Device
- Where
- 3 sites in Madagascar, South Africa and 1 more
- Volunteers
- 675 people
- Sponsor
- University of Cape Town