Clinical trials: CtDNA
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.
Cancer, Lung, Cancer, Breast
Early Detection of Five Common Cancers Using the ctDNA Analysing Test
This is a multi-centre, prospective cohort study, aiming to evaluate a blood test in early detection of the four common cancers, based on the investigation of the circulating tumour DNA (ctDNA).
- Conditions
- Cancer, Lung, Cancer, Breast, Cancer Liver, Cancer, Colorectal
- Trial name
- K-DETEK (NCT05227261)
- Where
- Vietnam
- Volunteers
- 9,057 people, healthy volunteers welcome
- Sponsor
- Gene Solutions
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.
Colon Cancer, Colon Adenomas
Plasma ctDNA in Patients Undergoing Diagnostic Colonoscopy
When the DNA inside of human cells undergoes certain alterations (mutations), the cells may develop into a cancer. The cancer cells may shed this DNA into the blood stream.
- Conditions
- Colon Cancer, Colon Adenomas, Colon Polyps
- Trial name
- NCT02665299
- Where
- United States
- Volunteers
- 206 people, healthy volunteers welcome
- Sponsor
- Pathway Genomics
Cancer
Galleri® in the Medicare Population.
This multi-center comparative prospective cohort study is designed to assess the real world clinical impact, including safety and test performance, of Galleri®, a blood-based multi-cancer early detection (MCED) test.
- Trial name
- NCT05673018
- Testing
- Multi-Cancer Early Detection Test (Galleri®)
- Where
- 72 sites in United States
- Volunteers
- 50,000 people, healthy volunteers welcome
- Sponsor
- GRAIL, 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.
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.
Colorectal Cancer
Evaluation of the ctDNA LUNAR Test in an Average Patient Screening Episode
The ECLIPSE (Evaluation of the ctDNA LUNAR test in an Average Patient Screening Episode) study is a prospective, observational multi-site study without randomization.
- Trial name
- ECLIPSE (NCT04136002)
- Where
- 271 sites in United States
- Volunteers
- 44,467 people, healthy volunteers welcome
- Sponsor
- Guardant Health, Inc.
Colorectal Cancer, Pancreatic Adenocarcinoma
Circulating Tumor DNA Exposure in Peripheral Blood
This is a prospective, multi-center, blinded feasibility study. The objective of this study is to test the feasibility of the detection of tumor DNA of a variety of tumors in peripheral blood using a novel process for the…
- Conditions
- Colorectal Cancer, Pancreatic Adenocarcinoma, Gastric Cancer, Hepatocellular Carcinoma
- Trial name
- NCT03517332
- Where
- 6 sites in United States, Switzerland
- Volunteers
- 10,000 people, healthy volunteers welcome
- Sponsor
- Quantgene Inc.
Breast Cancer
Study on Early Auxiliary Diagnosis and Postoperative Recurrence Monitoring of Breast Cancer
This study screened and identified effective methylation markers in breast cancer, established a detection system for early screening and early diagnosis, and provided a research basis for the embryonic form of non-invasive…
- Trial name
- NCT05858242
- Where
- China
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Singlera Genomics Inc.
Early Detection of Cancer, Cancer
REFLECTION: A Clinical Practice Learning Program for Galleri®
REFLECTION is a multi-center, prospective, non-interventional, cohort study that will enroll approximately 14,000 individuals who have opted to be screened with Galleri®, a blood-based, multi-cancer early detection (MCED) test in…
- Trial name
- NCT05205967
- Testing
- MCED, SOC
- Where
- 16 sites in United States
- Volunteers
- 14,633 people, healthy volunteers welcome
- Sponsor
- GRAIL, Inc.
Brest Cancer, Lung Cancer (NSCLC)
The CCANED-CIPHER Study: Early Cancer Detection and Treatment Response Monitoring Using AI-Based Platelet and Immune Cell Transcriptomic Profiling
The purpose of the CCANED-CIPHER study is to develop and validate an AI-based blood test for early cancer detection and to monitor treatment effectiveness in cancer patients.
- Conditions
- Brest Cancer, Lung Cancer (NSCLC), Pancreatic Cancer, Adult, Prostate Cancers
- Trial name
- CCANED-CIPHER (NCT06717295)
- Testing
- DiNanoQ: A multi-cancer early detection (MCED) blood test, DiNanoTrack: Therapeutic Response Monitoring Blood Test
- Where
- 4 sites in Argentina, Nigeria and 1 more
- Volunteers
- 6,000 people, healthy volunteers welcome
- Sponsor
- Javier Toledo
Pulmonary Nodule, Solitary, Whole-genome Methylation Sequencing
Benign/Malignant Pulmonary Nodule Classification Based on High-throughput Whole-genome Methylation Sequencing(GM-seq)
Lung cancer is the first cancer in China in terms of morbidity and mortality. The problem of early diagnosis/treatment has always been concerned.
- Trial name
- NCT05415670
- Testing
- Whole-genome Methylation Sequencing(GM-seq)
- Where
- 2 sites in China
- Volunteers
- 158 people, healthy volunteers welcome
- Sponsor
- Geneplus-Beijing Co. Ltd.
Mutation, Neoplasms
Utility of Plasma Circulating Tumor DNA (ctDNA) in Asymptomatic Subjects for the Detection of Neoplastic Disease
Pathway Genomics Corporation (Pathway Genomics), a San Diego, California company, is involved in the development and validation of new molecular diagnostic assays for the analysis of circulating tumor deoxyribonucleic acid (DNA)…
- Trial name
- H1000 (NCT02612350)
- Testing
- ctDNA Analysis for the Detection of Genetic Mutations
- Where
- United States
- Volunteers
- 1,106 people, healthy volunteers welcome
- Sponsor
- Pathway Genomics
Colorectal Cancer
A Prospective Cohort Study on Colorectal Cancer Screening in Community Population
This study will validate the real world results of polygene methylation detection in colorectal cancer in a large prospective community cohort.
- Trial name
- NCT05485077
- Where
- China
- Volunteers
- 18,000 people, healthy volunteers welcome
- Sponsor
- Singlera Genomics Inc.
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.
Colorectal Cancer Screening
Sample Collection Study for the CellMax Life Circulating Tumor Cell and Circulating Tumor DNA Platforms for the Early Detection of Colorectal Cancer and Adenomas
The purpose of this study is to collect clinical specimens from subjects with a diagnosis of colorectal cancer/advanced adenoma or undergoing a screening colonoscopy and meeting study eligibility criteria.
- Trial name
- NCT05127096
- Testing
- FirstSight blood test
- Where
- 15 sites in United States
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- CellMax Life
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
Colorectal Cancer
Clinical Validation of ColonAiQ (a Blood-based Assay Targeting ctDNA Methylation) for Colorectal Cancer Detection
The DNA methylation targets in preoperative plasma samples of the subjects will be detected by the multi-gene methylation test (ColonAiQ), and the test accuracy will be evaluated by compared with the clinical diagnosis evidence.
- Trial name
- NCT06347887
- Testing
- ColonAiQ test and Colonoscopy
- Where
- 7 sites in China
- Volunteers
- 1,965 people, healthy volunteers welcome
- Sponsor
- Singlera Genomics Inc.
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.