Clinical trials: Next-generation Sequencing
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.
Infertility, Aneuploidy
Single Embryo TrAnsfeR of Euploid Embryo
The purpose of the current study is to evaluate the effect of preimplantation genetic screening (PGS) by next generation sequencing (NGS) compared to standard morphological assessment of embryos on pregnancy rates through a…
- Trial name
- STAR (NCT02268786)
- Testing
- Preimplantation Genetic Screening by NGS
- Where
- 38 sites in United States, Australia and 2 more
- Volunteers
- 661 people
- Sponsor
- Illumina, Inc.
Acute Myeloid Leukaemia (AML), Follicular Lymphoma ( FL)
A Longitudinal Multi-Center Molecular Biomarker Discovery Registry for Patients With Hematologic Malignancies
The TEMPUS AQUARIUS Study is a non-interventional, longitudinal observational study focused on hematological malignancies. It will collect rich molecular (multi-omic) and clinical data from patient cohorts through serial blood…
- Trial name
- Aquarius (NCT07154823)
- Testing
- None - Observational Study
- Where
- 13 sites in United States
- Volunteers
- 550 people
- Sponsor
- Tempus AI
Advanced Solid Tumor, Advanced Malignant Neoplasm
The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)
The Phase 2 monotherapy portion of this study is currently enrolling and will evaluate the efficacy and safety of PC14586 (INN rezatapopt) in participants with locally advanced or metastatic solid tumors harboring a TP53 Y220C…
- Conditions
- Advanced Solid Tumor, Advanced Malignant Neoplasm, Metastatic Cancer, Metastatic Solid Tumor
- Trial name
- NCT04585750
- Testing
- rezatapopt, pembrolizumab
- Where
- 76 sites in United States, Australia and 7 more
- Volunteers
- 300 people
- Sponsor
- PMV Pharmaceuticals, Inc
Cancer, Neoplasm Metastasis
FoundationOne™ Test Registry Study
This study is a prospective, multicenter, observational study to characterize utilization patterns of the FoundationOne™ test by oncologists under conditions of routine clinical practice in the US.
- Conditions
- Cancer, Neoplasm Metastasis, Tumor
- Trial name
- FMI Registry (NCT01851213)
- Where
- United States
- Volunteers
- 510 people
- Sponsor
- Foundation Medicine
Leiomyoma, Leiomyosarcoma
Development of a Predictive Model for Early Differential Diagnosis of Uterine Leiomyomas and Leiomyosarcomas
The development of an accurate and non-invasive diagnostic method is a priority in areas such as gynecology and oncology, specifically to improve the health of those patients with surgical indication for diagnosis of myometrial…
- Trial name
- MYOSARC (NCT04214457)
- Testing
- Biopsy and peripheral blood collection
- Where
- 4 sites in Spain
- Volunteers
- 1,000 people
- Sponsor
- Igenomix
Neoplasms, Cancer
The Circulating Cell-free Genome Atlas Study
GRAIL is using deep sequencing of circulating cell-free nucleic acids (cfNAs) to develop assays to detect cancer early in blood.
- Trial name
- CCGA (NCT02889978)
- Where
- 140 sites in United States, Canada
- Volunteers
- 15,254 people, healthy volunteers welcome
- Sponsor
- GRAIL, Inc.
Lung Neoplasms, Lung Cancer, Nonsmall Cell
Therapeutic ResistAnce and Clonal Evolution Assessed With Liquid Biopsy in ICIs Treated NSCLC Patients
To evaluate the predictive value of ctDNA in response, relapse for patients treated with immune checkpoint inhibitors or targeted therapy for ALK, ROS1, MET ex14 skipping.
- Conditions
- Lung Neoplasms, Lung Cancer, Nonsmall Cell, Adenocarcinoma of Lung, Squamous Cell Lung Cancer
- Trial name
- NCT04566432
- Testing
- Observation
- Where
- China
- Volunteers
- 252 people
- Sponsor
- Geneplus-Beijing Co. Ltd.
Solid Tumor, Unspecified, Adult
Tissue Collection for Correlation Between ATM Alterations by Next-Generation Sequencing and ATM Loss-of-Protein
This study examines the correlation between ATM alterations identified using NGS profiles with ATM protein expression levels from tumor tissue assessed by IHC.
- Trial name
- ATM (NCT04976803)
- Testing
- Determination of ATM alteration status.
- Where
- 3 sites in United States, United Kingdom
- Volunteers
- 229 people
- Sponsor
- Artios Pharma Ltd
Non-Small Cell Lung Cancer, Non-squamous Non-small-cell Lung Cancer
KEAPSAKE: A Study of Telaglenastat (CB-839) With Standard-of-Care Chemoimmunotherapy in 1L KEAP1/NRF2-Mutated, Nonsquamous NSCLC
This is a Phase 2, randomized, multicenter, double-blind study of the glutaminase inhibitor telaglenastat with standard-of-care pembrolizumab and chemotherapy versus placebo with standard-of-care pembrolizumab and chemotherapy…
- Conditions
- Non-Small Cell Lung Cancer, Non-squamous Non-small-cell Lung Cancer, Non-Squamous Non-Small Cell Neoplasm of Lung, KEAP1 Gene Mutation
- Trial name
- KEAPSAKE (NCT04265534)
- Testing
- Telaglenastat, Carboplatin Chemotherapy, Pemetrexed Chemotherapy
- Where
- 102 sites in United States
- Volunteers
- 40 people
- Sponsor
- Calithera Biosciences, Inc
Down Syndrome, Edwards Syndrome
Clinical Performance of the MaterniT21 PLUS LDT in Multiple Gestation Pregnancies
This study will evaluate the clinical performance of massively parallel sequencing (MPS) using the MaterniT21 PLUS LDT in the detection of fetal aneuploidy in circulating cfDNA extracted from a maternal blood sample obtained from…
- Conditions
- Down Syndrome, Edwards Syndrome, Patau Syndrome, Turner Syndrome
- Trial name
- NCT02226315
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Sequenom, Inc.
Non Small Cell Lung Cancer, Neoepitopes
AImmune - Artificial Intelligence Algorithm for Identification of Immunogenic Neoepitopes of Cancer to Predict and Boost Patient's Response to Immunotherapies.
The goal of the project is to develop and validate A.I.mmune technology. It performs complex analyses of patients' tumor and immune system state using data derived from next-generation sequencing of tumor and healthy tissue to…
- Conditions
- Non Small Cell Lung Cancer, Neoepitopes, Neoantigens, Immunotherapy
- Trial name
- NCT04145232
- Testing
- Collection of biopsy (FFPE), blood (PBMC) and stool
- Where
- Poland
- Volunteers
- 30 people
- Sponsor
- Ardigen
Small Cell Lung Cancer
Tempus Small Cell Lung Cancer Observational Study (Sculptor)
The study is a non-interventional evaluation of participants with extensive stage (ES) SCLC who will receive diagnostic and (where possible) post-progression tumor tissue profiling, alongside plasma ctDNA and CTC biomarker…
- Trial name
- NCT05257551
- Testing
- Observation
- Where
- 11 sites in United States
- Volunteers
- 200 people
- Sponsor
- Tempus AI
Penile Implantation, Infections
Next Generation Sequencing Versus Traditional Cultures for Clinically Infected Penile Implants: Impact of Culture Identification on Outcomes
Randomized prospective study to evaluate next generation sequencing (NGS) and standard-of-care culture for clinically infected penile implants and to compare outcomes with identification of microbes.
- Trial name
- NCT05287438
- Testing
- Next-Generation DNA Sequencing, Standard Culture
- Where
- 3 sites in United States
- Volunteers
- 40 people
- Sponsor
- MicroGenDX
Encephalitis
SouthEast Asia Encephalitis Project
Encephalitis, an acute inflammation of the central nervous system associated with neurologic dysfunction is of public health concern worldwide, because of its high mortality and neurological sequelae rates.
- Trial name
- SEAe (NCT04089436)
- Testing
- CSF sampling, Blood sampling, Nasopharyngeal and rectal sampling
- Where
- 7 sites in Burma, Cambodia and 2 more
- Volunteers
- 800 people
- Sponsor
- Institut Pasteur
Pulmonary Nodules
Diagnostic and Monitoring Significance of ctDNA Methylation Analysis by NGS in Benign and Malignant Pulmonary Nodules
AnchorDx is using circulating tumor DNA (ctDNA) methylation analysis by next-generation sequencing (NGS) to develop a blood-based assay for differentiating benign and malignant pulmonary nodules early.
- Trial name
- NCT03651986
- Testing
- ctDNA methylation analysis by NGS
- Where
- 23 sites in China
- Volunteers
- 10,560 people, healthy volunteers welcome
- Sponsor
- AnchorDx Medical Co., Ltd.
Cancer
TEMPUS ARIES: A Biobank Registry Platform Study in Oncology
This study is a non-interventional, multicenter, multicohort evaluation of participants with cancer who will undergo longitudinal plasma ctDNA biomarker profiling at specific time points in addition to standard of care therapy.
- Trial name
- NCT06207032
- Where
- 32 sites in United States, Puerto Rico
- Volunteers
- 500 people
- Sponsor
- Tempus AI
Lung Neoplasms, Lung Cancer, Nonsmall Cell
Therapeutic ResistAnce and Clonal Evolution Assessed With Liquid Biopsy of NSCLC Patients in China
To evaluate the concordance of sensitizing mutations detected between paired plasma and tissue samples; the correlation between the clonal status of sensitizing mutations and targeted therapy response; and the prognostic impact…
- Conditions
- Lung Neoplasms, Lung Cancer, Nonsmall Cell, Adenocarcinoma of Lung, Squamous Cell Lung Cancer
- Trial name
- NCT03059641
- Where
- 14 sites in China
- Volunteers
- 300 people
- Sponsor
- Geneplus-Beijing Co. Ltd.
Preeclampsia
Development of a Next Generation Sequencing (NGS) -Based Assay to Detect Preeclampsia Molecular Markers
Sample Collection Study
- Trial name
- NCT02808494
- Where
- 10 sites in United States
- Volunteers
- 242 people
- Sponsor
- Illumina, Inc.
Solid Tumor, Adult, Oncology
POA Prospective Repository
This repository is a multi-center, outcomes study designed to collect data on the demographics, presentation, diagnosis, treatment, cost of associated care, quality of life, and outcomes of subjects utilizing Caris Molecular…
- Trial name
- NCT03324841
- Testing
- Caris MI Profiling
- Where
- 11 sites in United States
- Volunteers
- 10,000 people
- Sponsor
- Caris Science, Inc.