Clinical trials: Cell Free DNA
Neoplasms, Cancer
The STRIVE Study: Development of a Blood Test for Early Detection of Multiple Cancer Types
GRAIL is using high-intensity sequencing of circulating cell-free nucleic acids (cfNAs) to develop blood tests to detect cancer early.
- Trial name
- NCT03085888
- Where
- 35 sites in United States
- Volunteers
- 99,481 people, healthy volunteers welcome
- Sponsor
- GRAIL, Inc.
Adenocarcinoma, Adenocystic Carcinoma
The Registry of Oncology Outcomes Associated With Testing and Treatment
This study is to collect and validate regulatory-grade real-world data (RWD) in oncology using the novel, Master Observational Trial construct. This data can be then used in real-world evidence (RWE) generation.
- Conditions
- Adenocarcinoma, Adenocystic Carcinoma, Anal Cancer, Appendix Cancer
- Trial name
- ROOT (NCT04028479)
- Testing
- Biomarker Testing (L), Systemic Treatment (T), Patient Reported Outcomes (P)
- Where
- 2 sites in United States
- Volunteers
- 167 people
- Sponsor
- Taproot Health
Heart Transplant Failure and Rejection
A Comparative Effectiveness Study in Heart Transplant Patients of Rejection Surveillance With Cell-free DNA Versus Endomyocardial Biopsy
This is an open label Comparative Effectiveness Research (CER) study in which patients will be randomized at the site level to Prospera surveillance or EMB surveillance in a 2:1 ratio (Prospera to EMB) at each site.
- Trial name
- ACES-EMB (NCT06414603)
- Testing
- The Prospera™ Test
- Where
- 16 sites in United States
- Volunteers
- 250 people
- Sponsor
- Natera, Inc.
Kidney Transplant Recipients
Non Invasive Blood Test To Diagnose Acute Rejection After Kidney Transplantation
This is a prospective, multicenter, observational study of kidney transplant subjects where blood specimens, intended for dd-cfDNA and other future research purposes, will be drawn after transplant
- Trial name
- DART (NCT02424227)
- Where
- 14 sites in United States
- Volunteers
- 401 people
- Sponsor
- CareDx
Kidney Transplant Rejection, Cell-free DNA
Validation of Donor-Derived Cell-Free DNA (Dd-cfDNA) for Kidney Transplant Monitoring
The goal of this observational study is to learn if the donor-derived cell-free DNA (dd-cfDNA) test can assess rejection in kidney transplant recipients. Participants will have blood and urine collected at their study visit.
- Trial name
- NCT07060716
- Testing
- donor-derived cell-free DNA test
- Where
- 10 sites in United States, Germany
- Volunteers
- 125 people
- Sponsor
- Insight Molecular Diagnostics
Cancer
Does Screening With the Galleri Test in the NHS Reduce the Likelihood of a Late-stage Cancer Diagnosis in an Asymptomatic Population? A Randomised Clinical Trial
The Galleri test is a new test that looks for potential signs of cancer in a blood sample. The test can find many different types of cancer but cannot find all cancers.
- Trial name
- NHS-Galleri (NCT05611632)
- Testing
- Multi-cancer early detection test (Galleri test)
- Where
- United Kingdom
- Volunteers
- 142,318 people, healthy volunteers welcome
- Sponsor
- GRAIL, Inc.
Cancer, Early Detection of Cancer
Multi-canceR Early-detection Test in Asymptomatic Individuals (PREVENT)
PREVENT is a prospective, multicenter, interventional study evaluating the performance of the OverC multi-cancer detection blood test in asymptomatic individuals with cancer risk.
- Conditions
- Cancer, Early Detection of Cancer, Circulating Cell-free DNA
- Trial name
- PREVENT (NCT05227534)
- Testing
- OverC multi-cancer detection blood test
- Where
- China
- Volunteers
- 12,500 people, healthy volunteers welcome
- Sponsor
- Guangzhou Burning Rock Dx Co., Ltd.
Cardiac Transplant Failure, Cardiac Transplant Rejection
Utility of Donor-Derived Cell Free DNA in Association With Gene Expression Profiling
Plasma donor-derived cell-free DNA (dd-cfDNA) is measured as a % of the total plasma cfDNA in association with the measurement of AlloMap, a non-invasive gene expression test to aid in heart transplant management.
- Conditions
- Cardiac Transplant Failure, Cardiac Transplant Rejection, Heart Diseases
- Trial name
- D-OAR (NCT02178943)
- Where
- 28 sites in United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- CareDx
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.
Lung Cancer, Colorectal Cancer
ProSight: A Multi-centre Interventional Study Evaluating MCED in Asymptomatic Population
This is a prospective, multi-centre interventional study evaluating the feasibility of blood-based multi-cancer early detection test in asymptomatic screening cohort.
- Conditions
- Lung Cancer, Colorectal Cancer, Liver Cancer, Grastic Cancer
- Trial name
- NCT06790355
- Testing
- multi-cancer early detection
- Where
- 4 sites in China
- Volunteers
- 2,527 people, healthy volunteers welcome
- Sponsor
- Shanghai Weihe Medical Laboratory Co., Ltd.
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.
Non Small Cell Lung Cancer
LIQUIK: LIQUId Biopsy for Detection of Actionable Genomic BiomarKers in Patients With Advanced Non-small Cell Lung Cancer (NSCLC)
To explore the non-inferiority of a cfDNA amplicon-based liquid biopsy technology vs. standard of care tissue biopsy-based NGS in detecting guideline- recommended biomarkers in patients with metastatic non-squamous Non-small Cell…
- Trial name
- LIQUIK (NCT04703153)
- Where
- 5 sites in United States
- Volunteers
- 151 people
- Sponsor
- Lucence Health Inc.
Cancer
Pan-canceR Early DetectIon projeCT
PREDICT is a prospective, multi-center study for the early detection of pan-cancer through cell-free DNA (cfDNA) methylation based model, in which approximately 14,000 participants will be enrolled.
- Trial name
- PREDICT (NCT04383353)
- Where
- 3 sites in China
- Volunteers
- 14,026 people, healthy volunteers welcome
- Sponsor
- Guangzhou Burning Rock Dx Co., Ltd.
Gastric Cancer
Gastric Cancer Early Detection by Multi-dimensional Analysis of cfDNA
To facilitate the early gastric cancer diagnosis, an assay based on assessing large-scale methylation and fragmentation profiles of the plasma cell free (cfDNA) will be developed and validated.
- Trial name
- NCT05668910
- Testing
- whole genomic methylation and fragmentation profile analysis of cfDNA
- Where
- China
- Volunteers
- 360 people, healthy volunteers welcome
- Sponsor
- GeneCast Biotechnology Co., Ltd.
Kidney Diseases, Kidney Injury
ID-ENTITY Trial- Evaluating Serial T-ID Monitoring
To evaluate the association between time-updated CMV and BK viral loads measured monthly by T-ID and the risk of CMV disease and/or biopsy-proven BK virus-associated nephropathy (BKVAN) during the first 12 months following kidney…
- Conditions
- Kidney Diseases, Kidney Injury, BK Virus Infection, CMV
- Trial name
- ID-ENTITY (NCT07393594)
- Testing
- Blood tests, TRAC( cell free DNA) and T-ID
- Where
- 14 sites in United States
- Volunteers
- 1,000 people
- Sponsor
- Transplant Genomics, Inc.
Heart Transplant, Immunosuppression
HeartCare Immuno-optimization in Cardiac Allografts (MOSAIC)
This is an unblinded, randomized, controlled, two-arm interventional research study enrolling patients who are undergoing heart transplantation.
- Conditions
- Heart Transplant, Immunosuppression, Allograft
- Trial name
- MOSAIC (NCT05459181)
- Testing
- HeartCare
- Volunteers
- 930 people
- Sponsor
- CareDx
Brain Cancer, Breast Cancer
cfDNA Assay Prospective Observational Validation for Early Cancer Detection and Minimal Residual Disease
This is an observational case-control study to train and validate a genome-wide methylome enrichment platform to detect multiple cancer types and to differentiate amongst cancer types.
- Conditions
- Brain Cancer, Breast Cancer, Bladder Cancer, Cervical Cancer
- Trial name
- CAMPERR (NCT05366881)
- Where
- 17 sites in United States
- Volunteers
- 7,000 people, healthy volunteers welcome
- Sponsor
- Adela, Inc
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
Kidney Disease, Kidney Transplant
A Multicenter, Prospective Blood Collection Study in a Kidney Transplant Population
The purpose of this research is to collect blood samples and data from kidney transplant patients. The samples and data will be used for research and development of non-invasive test to detect donor-derived cell-free DNA…
- Conditions
- Kidney Disease, Kidney Transplant, Transplant Recipient, Renal Function
- Trial name
- Accept cfDNA (NCT07006831)
- Where
- 6 sites in United States
- Volunteers
- 400 people
- Sponsor
- Devyser Inc.
Transplant Rejection, Transplant Kidney
Study of the Plasma and Urinary cfDNA of in Kidney Transplant Patients
It has been shown that the amount of circulating donor-cell-free DNA increases in patients with transplant rejection. Quantification of single nucleotide polymorphisms (SNPs) present in circulating donor DNA currently allows for…
- Trial name
- PLAKID-TRANSP (NCT06910527)
- Where
- France
- Volunteers
- 250 people
- Sponsor
- Poulet Geoffroy