Clinical trials: Laboratory Procedure Development and Validation
- Condition Laboratory Procedure Development and Validation
- Funder type Industry (pharma, biotech, devices)
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.
Non Small Cell Lung Cancer (NSCLC), Melanoma (Skin Cancer)
Neutrophil Biomarker Test for Predicting Clinical Benefit From Immunotherapy Based on Flow Cytometry Analysis
The NeutroFlow study is a multi-center clinical trial designed to develop a computational model that converts flow cytometry results into a prediction of clinical benefit.
- Conditions
- Non Small Cell Lung Cancer (NSCLC), Melanoma (Skin Cancer), Triple Negative Breast Cancer (TNBC), RCC, Renal Cell Cancer
- Trial name
- NEUTROFLOW (NCT07246759)
- Testing
- Blood sample collection
- Where
- 3 sites in Germany, Italy and 1 more
- Volunteers
- 600 people
- Sponsor
- OncoHost Ltd.
Insulin Sensitivity/Resistance
Assessment of Insulin Sensitivity in Healthy Adults by a 13C-glucose Breath Test : Method Development and Validation
The current research project aims to assess the insulin resistance (less sensitivity), from measures of insulin and glucose in response to a standard oral intake of glucose (standardized oral glucose tolerance test).
- Trial name
- NCT06766617
- Testing
- 75 gr Glucose
- Where
- Switzerland
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Renal Failure, End Stage Renal Disease
Development, Feasibility Testing and Validation of a Survey Set to Measure Patient-Reported Outcomes Among Hemodialysis Patients in Turkey
Development, feasibility testing and validation of a Survey Set to Measure Patient-Reported Outcomes among Hemodialysis Patients in Turkey: Creating and testing an electronic patient questionnaire that is suitable to measure…
- Trial name
- DOPRO (NCT05441020)
- Testing
- Administration of patient questionnaire
- Where
- 7 sites in Turkey (Türkiye)
- Volunteers
- 173 people
- Sponsor
- Fresenius Medical Care Deutschland GmbH
Dengue
Dengue - Sample Collection Study Pakistan
The objective of this study is to collect well-characterized serum and plasma specimens from confirmed dengue positive and dengue negative subjects to support dengue diagnostic products development.
- Trial name
- NCT07203183
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Abbott Rapid Dx
Growth Hormone Deficiency
Comparative Validation of the Growth Hormone Releasing Hormone and Arginine Test for the Diagnosis of Adult Growth Hormone Deficiency
The aim of the study is to determine the specificity and sensitivity of the combined growth hormone releasing hormone (GHRH) + Arginine test in healthy volunteers, subjects with highly probable adult growth hormone deficiency…
- Trial name
- NCT01060488
- Testing
- GHRH+Arg, GHRH+Arg, ITT, ITT, ITT, GHRH+Arg.
- Where
- France
- Volunteers
- 69 people, healthy volunteers welcome
- Sponsor
- Merck KGaA, Darmstadt, Germany
Cardiac Arrythmias, Valve Heart Disease
FRAILTY Classification Algorithm for the Corsano CARDIOWATCH 287-2: a Development and Validation Study
The FRAILTY-CARDIOWATCH study is investigating how well the Corsano CardioWatch 287-2, a wrist-worn medical device, can classify frailty in patients.
- Conditions
- Cardiac Arrythmias, Valve Heart Disease, Cardiac Ischemia
- Trial name
- FRAILTY-CW2 (NCT06930833)
- Testing
- Corsano CardioWatch 287-2
- Where
- Netherlands
- Volunteers
- 20 people
- Sponsor
- Corsano Health B.V.
Liver Diseases, Healthy
Blood Collection for Development and Validation of Point-of-Care Diagnostic Liver Function Tests
This is an observational study exploring the performance of a novel point-of-care diagnostic testing platform designed to quantitate the presence of liver function biomarkers such as bilirubin.
- Conditions
- Liver Diseases, Healthy, Liver Cirrhosis, Liver Fibrosis
- Trial name
- NCT05457543
- Testing
- Adult
- Where
- United States
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Group K Diagnostics Inc.
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.
Chromosome 13 Aneuploidy, Chromosome 18 Aneuploidy
Non-invasive Prenatal Diagnostic Validation Study
The primary purpose of this study is to collect maternal blood samples from pregnant women to develop a non-invasive prenatal diagnostic test based on fetal DNA isolated from maternal blood.
- Conditions
- Chromosome 13 Aneuploidy, Chromosome 18 Aneuploidy, Chromosome 21 Aneuploidy, Sex Chromosome Aberrations
- Trial name
- NIPD (NCT01574781)
- Testing
- Blood draw, Cheek swab/Saliva Sampling
- Where
- United States
- Volunteers
- 1,781 people, healthy volunteers welcome
- Sponsor
- Natera, Inc.
Autism Spectrum Disorder, Developmental Delay
Validation of a Salivary miRNA Diagnostic Test for ASD
This study involves sample collection to identify biomarkers relating to Autism Spectrum Disorder(ASD) in the saliva of children who are between the ages of 18 months to 6 years and 11 months.
- Trial name
- NCT05418023
- Testing
- Salivary Collection, Adaptive Assessment, Medical and Demographic questionnaire
- Where
- 16 sites in United States
- Volunteers
- 6,604 people
- Sponsor
- Quadrant Biosciences Inc.
Asphyxia Neonatorum
Biomarkers And Neurological Outcome in Neonates 2
Follow-up of participants of BANON1 study at age of at least 2 years. BANON1 (ClinicalTrials.gov ID: NCT03357250): Validation of biomarkers based on 24 months neuro-developmental outcome data in a human population for their…
- Trial name
- BANON2 (NCT04714775)
- Where
- 13 sites in Germany, Turkey (Türkiye)
- Volunteers
- 500 people
- Sponsor
- InfanDx AG
Cancer
Development and Validation of Harbinger Health Test for Early Cancer Detection
This is a prospective, multi-center, observational study with a collection of biospecimens and clinical data from approximately 10,000 participants from up to 125 clinical network sites and locations in the United States.
- Trial name
- CORE-HH (NCT05435066)
- Testing
- Harbinger Health Test
- Where
- 128 sites in United States
- Volunteers
- 8,038 people, healthy volunteers welcome
- Sponsor
- Harbinger Health
Melanoma
Development and Multi-Centre Validation of a Novel Non-Invasive Melanoma Molecular Diagnostic Test
Background and Study Aims: Melanoma is the most dangerous form of skin cancer, and early detection is crucial for improving patient outcomes.
- Trial name
- MELODI (NCT07883954)
- Where
- 5 sites in Belgium, Germany and 2 more
- Volunteers
- 2,000 people
- Sponsor
- Mitra Bio
Colorectal Carcinoma, Advanced Adenomas (AA)
Development and Validation of a Blood Test for Early Diagnosis of Colorectal Cancer
This is a prospective, multicenter, case-control study. The aim is to develop an optimized algorithm by combining the levels of molecular markers in plasma together with risk factors for developing colorectal cancer and clinical…
- Trial name
- ColoDix (NCT06889883)
- Where
- 9 sites in Spain
- Volunteers
- 510 people, healthy volunteers welcome
- Sponsor
- ADVANCED MARKER DISCOVERY S.L.
Cancer
a PROspective Case Control Study to Develop and Validate a Blood Test FOr mUlti-caNcers Early Detection（PROFOUND）
This study is a multi-center, case-control study aiming at developing and blinded testing machine learning-based multiple cancers early detection model by prospectively collecting blood samples from newly diagnosed cancer…
- Trial name
- PROFOUND (NCT06217900)
- Where
- 8 sites in China
- Volunteers
- 16,666 people, healthy volunteers welcome
- Sponsor
- Shanghai Weihe Medical Laboratory Co., Ltd.
Thoracic Cancer, Ovarian Cancer
Project CADENCE (CAncer Detected Early caN be CurEd)
With existing evidence showing the difference in miRNA expression levels between non-cancer and cancer groups, the investigators assume that levels of DNA methylation, RNA expression as well as protein concentration will also be…
- Conditions
- Thoracic Cancer, Ovarian Cancer, Liver Cancer, Prostate Cancer
- Trial name
- CADENCE (NCT05633342)
- Where
- Singapore
- Volunteers
- 15,000 people, healthy volunteers welcome
- Sponsor
- MiRXES Pte Ltd