Clinical trials: Circulating Tumor DNA (ctDNA)
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
Metastatic Cancers
Assessing Systemic Treatment and ctDNA Monitoring Efficacy in Metastatic Cancer Patients Using K4Care Testing.
The goal of this observational study is to investigate the real-world treatment landscape of patients with metastatic cancer and determine the role of ctDNA in monitoring treatment response in patients with metastatic cancer who…
- Trial name
- GS_ZKM (NCT06929910)
- Where
- Vietnam
- Volunteers
- 200 people
- Sponsor
- Gene Solutions
Lung Cancer, Pulmonary Neoplasm
Rarecells Molecular Biomarkers for Early Detection of Lung Cancer
Early diagnosis of lung cancer is a public health priority. Additionally, early detection of recurrences after treatment is crucial for optimizing disease management.
- Trial name
- BioMolCTC (NCT06546007)
- Testing
- CTC-DNA
- Where
- Italy
- Volunteers
- 50 people
- Sponsor
- Rarecells Diagnostics SAS
Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer, Metastatic Cervical Cancer
HER-Seq: A Blood-based Screening Study to Identify Patients With HER2 Mutations for Enrollment Into Clinical Research Studies of Neratinib
This is a multi-center, observational genomic screening protocol to identify participants whose tumors harbor somatic mutations in the ERBB2 (HER2) gene, as measured in circulating tumor DNA (ctDNA) .
- Trial name
- NCT03786107
- Testing
- Almac HER-Seq Assay
- Where
- 22 sites in United States, France and 5 more
- Volunteers
- 1,583 people
- Sponsor
- Puma Biotechnology, Inc.
Non-hematologic Cancer
Specimen Collection From Patients With Non-Hematologic Cancer for Use in Development of a Liquid Biopsy Assay
This specimen collection is designed to obtain whole blood and tumor tissue from subjects diagnosed with cancer for the purpose of the development of a noninvasive liquid biopsy assay using next generation sequencing (NGS).
- Trial name
- NCT02586389
- Where
- United States
- Volunteers
- 3,000 people
- Sponsor
- Sequenom, Inc.
Neoplasms, Breast
Efficacy and Safety Comparison of Niraparib to Placebo in Participants With Human Epidermal Growth Factor 2 Negative (HER2-) Breast Cancer Susceptibility Gene Mutation (BRCAmut) or Triple-Negative Breast Cancer (TNBC) With Molecular Disease
This study will assess the efficacy and safety of Niraparib in participants with either tumor mutation in the BRCA gene (tBRCAmut) HER2- breast cancer (Independent of hormone receptor [HR] status, including HR positive [+] and…
- Trial name
- ZEST (NCT04915755)
- Testing
- Niraparib
- Where
- 198 sites in United States, Argentina and 25 more
- Volunteers
- 40 people
- Sponsor
- GlaxoSmithKline
CRC (Colorectal Cancer)
A Study to Evaluate INCA33890 in the Treatment of Circulating Tumor DNA-Positive Stage II/III Microsatellite Stable Colorectal Cancer After Curative Resection and Chemotherapy
The purpose of this study is to evaluate INCA33890 in the treatment of circulating tumor DNA-positive stage II/III microsatellite stable colorectal cancer after curative resection and chemotherapy.
- Trial name
- NEXERA-204 (NCT07823322)
- Testing
- INCA33890
- Volunteers
- 40 people
- Sponsor
- Incyte Corporation
Endometrial Cancer
Signatera Assessment in Early-Stage Endometrial Cancer
The goal of this clinical trial is to assess if circulating tumor DNA can guide adjuvant selection in high-intermediate risk early-stage endometrial cancer.
- Trial name
- SIGNAL-EMC 101 (NCT07339384)
- Testing
- Signatera Genome ultra-sensitive ctDNA blood test
- Where
- 12 sites in United States
- Volunteers
- 1,010 people
- Sponsor
- Natera, 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.
Breast Cancer Female, Stage II Breast Cancer
Predicting BReast cAncer Response to neoadjuVant Therapy by ctDNA Assessment
This is a prospective and observational study, aiming to determine the detection rate and change of CtDNA in blood samples of cancer patients before, during and after neoadjuvant treatment.
- Conditions
- Breast Cancer Female, Stage II Breast Cancer, Stage III Breast Cancer, HER2-positive Breast Cancer
- Trial name
- BRAVA (NCT06087120)
- Where
- 3 sites in Indonesia, Vietnam
- Volunteers
- 125 people
- Sponsor
- Gene Solutions
Cancer of the Lung, Lung Cancer
Circulating Tumor DNA in Patients at High Risk for Lung Cancer
Patients who are about to undergo a diagnostic or therapeutic bronchoscopy or thoracic surgery without a distant history of cancer will have their blood drawn for measurement of circulating tumor DNA (ctDNA) to validate the…
- Conditions
- Cancer of the Lung, Lung Cancer, Lung Neoplasms, Adenocarcinoma of the Lung
- Trial name
- NCT02715102
- Where
- United States
- Volunteers
- 39 people
- Sponsor
- Pathway Genomics
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
Lung Neoplasms
Circulating Tumor DNA in Surgical Lung Cancer Patients
Conduct a prospective study to detect the change of ctDNA of surgical lung cancer patients.
- Trial name
- NCT03081741
- Where
- China
- Volunteers
- 500 people
- Sponsor
- Shenzhen Gene Health Bio Tech Co., Ltd.
Thyroid Cancer, Thyroid Nodules
ctDNA in Patients With Thyroid Nodules
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
- Thyroid Cancer, Thyroid Nodules, Thyroid Adenoma, Thyroiditis
- Trial name
- NCT02778412
- Where
- United States
- Volunteers
- 66 people
- Sponsor
- Pathway Genomics
Breast Cancer
DNA-guided Second Line Adjuvant Therapy for High Residual Risk, Estrogen Receptor Positive, HER-2 Negative Breast Cancer (DARE)
A randomized, Phase II trial of circulating tumor DNA-guided second line Adjuvant therapy for high Residual risk, Estrogen Receptor positive, HER-2 negative breast cancer (DARE)
- Trial name
- DARE (NCT04567420)
- Testing
- Palbociclib, Fulvestrant, Adjuvant Therapy
- Where
- 19 sites in United States
- Volunteers
- 70 people
- Sponsor
- Criterium, Inc.
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
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.
Colorectal Cancer
First CORRECT Study of Minimal Residual Disease (MRD) Detection in Colorectal Cancer
The CORRECT - MRD I study will prospectively enroll patients who have undergone complete surgical resection for stage II or III colorectal cancer. Patients will be followed for up to 5 years for recurrence.
- Trial name
- MRD (NCT06398743)
- Testing
- MRD
- Where
- 22 sites in Israel, Italy and 3 more
- Volunteers
- 416 people
- Sponsor
- Exact Sciences Corporation
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.