Clinical trials: Cell Free DNA
22q.11.2 Deletion/Duplication
Non-Invasive Chromosomal Evaluation of 22q11.2
This study is being conducted to develop and evaluate a cell-free fetal DNA test (Harmony) for non-invasive prenatal detection of 22q11.2 chromosomal deletion or duplication.
- Trial name
- 22Q (NCT02541058)
- Where
- Belgium
- Volunteers
- 420 people, healthy volunteers welcome
- Sponsor
- Cindy Cisneros
Chronic Hepatitis B, Alcoholic Hepatitis
Alcohol Consumption and Plasma cfDNA Methylation in Chronic Hepatitis B
This is an observational, exploratory study designed to investigate the effect of different levels of alcohol consumption on plasma cell-free DNA (cfDNA) methylation profiles in participants with chronic hepatitis B.
- Trial name
- NCT07865520
- Testing
- Alcohol Consumption
- Where
- China
- Volunteers
- 85 people
- Sponsor
- Beijing Municipal Administration of Hospitals
Oropharynx Squamous Cell Carcinoma
SURVEILLE-HPV: Evaluation of HPV16 Circulating DNA as Biomarker to Detect the Recurrence, in Order to Improve Post Therapeutic Surveillance of HPV16-driven Oropharyngeal Cancers
SURVEILLE-HPV - A new post therapeutic surveillance strategy for HPV-driven oropharyngeal cancer based on HPV Circulating DNA measures.
- Trial name
- SURVEILLE-HPV (NCT05582122)
- Testing
- HPV16 Ct-DNA dosing
- Where
- 16 sites in France
- Volunteers
- 420 people
- Sponsor
- UNICANCER
Renal Cell Carcinoma
Disease Burden and Biology Using Tumor Cell Free DNA in Metastatic Kidney Cancer
This study will assess whether DNA released by kidney cancer into the blood stream and urine of patients can be used to monitor tumor burden and tumor response to treatment in patients receiving immunotherapy
- Trial name
- NCT04883827
- Testing
- Blood collection, Urine collection
- Where
- 3 sites in United States
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Vanderbilt-Ingram Cancer Center
Carcinoma, Non-Small-Cell Lung, Breast Neoplasms
TR(ACE) Assay Clinical Specimen Study
The TR(ACE) Assay is a quantitative in vitro diagnostic test run on the TR(ACE) Instrument intended for the measurement of high molecular weight human DNA from plasma as an aid to monitoring disease progression or response to…
- Trial name
- NCT02934360
- Testing
- TR(ACE) Assay Testing
- Where
- 16 sites in United States
- Volunteers
- 450 people
- Sponsor
- Biological Dynamics
Cancer, Healthy Participants
Prospective Study for the Development, Validation and Confirmation of a Multi-Cancer Early Detection Platform Through Whole-Genome Sequencing Analysis of Circulating DNA in Cancer and Non-Cancer Subjects
This is a prospective, multi-center clinical study of Multi-Cancer Early Detection (MCED) testing in cancer patients and healthy volunteers.
- Trial name
- NCT07598747
- Where
- South Korea
- Volunteers
- 6,000 people, healthy volunteers welcome
- Sponsor
- Chang Gon Kim
Glioma, IDH1/IDH2 Mutation
Non Invasive Detection of IDH1/2 Mutation in Gliomas
This trial develops a non invasive diagnostic approach of IDH1 mutated gliomas combining mutation detection from free plasmatic DNA, D-2HG dosage in urine samples, and D-2HG detection by Brain Spectro MRI.
- Trial name
- IDASPE (NCT02597335)
- Testing
- Spectro-MRI, Dosage of free circulating plasmatic DNA, Dosage of D-2HG in the urine
- Where
- France
- Volunteers
- 40 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Down Syndrome, Fetal Aneuploidy
Clinical Evaluation of the SEQureDx T21 Test In High Risk Pregnancies
Whole blood samples will be collected from high-risk pregnant women to validate the clinical performance of the SEQureDx Trisomy 21 Test.
- Trial name
- NCT01555346
- Where
- 29 sites in United States, Canada
- Volunteers
- 3,062 people
- Sponsor
- Sequenom, Inc.
Tuberculosis, Pleural
Diagnostic Utility of Mycobacterium Tuberculosis Cell-free DNA
Tuberculosis (TB) is one of the major global health threats and is the second leading infectious cause of death after COVID-19 in 2022.
- Trial name
- MYDNITE-2 (NCT06439810)
- Testing
- Mycobacterium tuberculosis (MTB) cell-free DNA (cfDNA)
- Where
- Hong Kong
- Volunteers
- 400 people
- Sponsor
- Chinese University of Hong Kong
Maternal Neoplasia
IDENTIFY Study: Natural History of Maternal Neoplasia
Background: Pregnant women can get a DNA analysis of their blood. The test tells a woman and her doctor about the DNA of her unborn baby. But some women get test results that are abnormal or not reportable.
- Trial name
- NCT04049604
- Testing
- NIPT
- Where
- United States
- Volunteers
- 365 people
- Sponsor
- National Human Genome Research Institute (NHGRI)
Fetal Sex Determination
Evaluation of Fetal Sex in Assisted Reproductive Technology (ART) Achieved Pregnancies
Whole blood and urine samples will be collected from pregnant woman of gestational age 36-56 days as confirmed by artificial reproductive technology (ART).
- Trial name
- PREVIEW (NCT01021085)
- Where
- 3 sites in United States
- Volunteers
- 500 people
- Sponsor
- Sequenom, Inc.
Heart Transplant Rejection
Donor-derived Cell Free DNA as a New Biomarker in Cardiac Acute Rejection
FreeDNA-CAR is a prospective, observational multicenter study, that will include a total of 200 adult heart transplant (HT) patients from 14 centers in Spain.
- Trial name
- FreeDNA-CAR (NCT04973943)
- Testing
- Donor-derived cell Free DNA
- Where
- 12 sites in Spain
- Volunteers
- 200 people
- Sponsor
- Puerta de Hierro University Hospital
Colorectal Cancer
A Model for the Early Diagnosis of Colorectal Cancer by the Detection of 5-hydroxymethylcytosine (5-hmC) in Plasma Cell-free DNA
In this study, the investigators establish a model for the early diagnosis of colorectal cancer based on detection of 5-hydroxymethylcytosine (5-hmC) in training group and validate the effectiveness of the model using a…
- Trial name
- NCT03599947
- Where
- China
- Volunteers
- 1,400 people, healthy volunteers welcome
- Sponsor
- Fudan University
Microdeletion Syndromes, Trisomy 21
Development of Non-invasive Prenatal Test for Microdeletion and Other Genetic Syndromes Based on Cell Free DNA
The purpose of this study is to collect blood from families with a child who has been diagnosed with a chromosomal disorder including microdeletions in order to further develop a non-invasive prenatal screening test based on…
- Conditions
- Microdeletion Syndromes, Trisomy 21, Trisomy 18, Trisomy 13
- Trial name
- Microdel Triad (NCT02109770)
- Where
- 2 sites in United States
- Volunteers
- 216 people
- Sponsor
- Natera, Inc.
Hereditary Cancer Syndrome
Cell-free DNA in Hereditary And High-Risk Malignancies 1
The goal of this study is to develop an effective, sensitive blood test that can detect early tumours in patients with known or suspected hereditary cancer syndromes (HCS).
- Trial name
- CHARM1 (NCT04261972)
- Testing
- Next generation sequencing (NGS)
- Where
- 7 sites in Canada
- Volunteers
- 1,416 people
- Sponsor
- University Health Network, Toronto
Thoracic Organ Transplantation
Genome Transplant Dynamics
Study Description: Heart and lung transplants can save lives, but long-term success is often limited by organ rejection that is hard to detect early.
- Trial name
- NCT02423070
- Where
- 7 sites in United States
- Volunteers
- 991 people
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Transplant;Failure,Kidney, Transplant; Failure, Pancreas
Eliminating the Need for Pancreas Biopsy Using Peripheral Blood Cell-free DNA
Donor-derived cell-free DNA (dd-cfDNA) has shown promise as an early marker for cellular injury caused by rejection. dd-cfDNA changes may also indicate other injuries that lead to progressive decline in transplant organ function…
- Conditions
- Transplant;Failure,Kidney, Transplant; Failure, Pancreas, Rejection Acute Renal, Rejection Acute Pancreas
- Trial name
- PancDX (NCT04166149)
- Testing
- dd-cfDNA Blood Test
- Where
- 3 sites in United States
- Volunteers
- 140 people
- Sponsor
- University of Maryland, Baltimore
Kidney Transplant Rejection
ddcfDNA in Kidney Transplant Recipients
The objective of this study is to predict subclinical Antibody-Mediated Rejection (ABMR) occurrences in de novo DSA-positive recipients maintaining stable renal function after transplantation.
- Trial name
- NCT06013358
- Testing
- AlloSeq cfDNA
- Where
- South Korea
- Volunteers
- 200 people
- Sponsor
- Seoul National University Hospital
Brain Abscess
Circulating Cell-Free DNA for Brain Abscess Diagnosis: A Pilot Study
Brain abscess is a severe intracranial infection associated with significant morbidity and mortality. Standard management combines neurosurgical intervention, when feasible, with prolonged intravenous antibiotic therapy.
- Trial name
- METABCES-PoC (NCT07479225)
- Testing
- Plasma Microbial Cell-Free DNA Metagenomic Sequencing
- Where
- 2 sites in France
- Volunteers
- 15 people
- Sponsor
- University Hospital, Grenoble
Gestational Diabetes Mellitus (GDM)
Imprinting in Metabolic Diseases - Identifying Epigenetic Mechanisms in Human Gestational Diabetes Through Cell-free DNA
This clinical trials aims to investigate the impact of parental metabolism during pregnancy on fetal epigenetic signatures. The metabolic profiles of both parents will be evaluated through a blood sample collected from the father…
- Trial name
- Epi_GDM (NCT07436195)
- Testing
- Metabolic and epigenetic characterization of parents ans fetuses
- Where
- Germany
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- University of Ulm