Clinical trials: CtDNA
Carcinoma, Non-Small Cell Lung
A Study Evaluating the Efficacy and Safety of Adjuvant Platinum-Doublet Chemotherapy, With or Without Atezolizumab, in Patients Who Are ctDNA Positive After Complete Surgical Resection of Stage IB to Select IIIB Non-Small Cell Lung Cancer
This is a Phase II, multicenter, double-blind, randomized study designed to evaluate the efficacy and safety of adjuvant treatment with atezolizumab in combination with platinum-doublet chemotherapy followed by atezolizumab…
- Trial name
- CATHAYA (NCT04611776)
- Testing
- Atezolizumab, Carboplatin, Cisplatin
- Sponsor
- Hoffmann-La Roche
Colorectal Cancer Stage II, Colorectal Cancer Stage III
Epidemiological Study to Monitor Study Participants With Resected Stage II (High Risk) or Stage III Colorectal Cancer for Circulating Tumor DNA Before, During and After Their Treatment With Adjuvant Chemotherapy
This is a multi-site epidemiological study designed to monitor circulating tumor DNA (ctDNA) status in participants with Stage II (high risk)/III colorectal cancer (CRC) following resection/prior to adjuvant chemotherapy (AdCTx)…
- Trial name
- NCT04813627
- Testing
- Regular blood sample collection for ctDNA assessment
- Where
- 74 sites in United States, Belgium and 2 more
- Volunteers
- 2,079 people
- Sponsor
- BioNTech SE
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
Breast Neoplasms, Carcinoma, Ductal, Breast
Signatera-Guided CDK4/6 Inhibitor Therapy in Breast Cancer
The purpose of this study is to evaluate the efficacy and safety of ctDNA-guided initiation of CDK4/6 inhibitor therapy using the Signatera™ Designed on Genome test (referred to as "Signatera Genome") in participants with…
- Conditions
- Breast Neoplasms, Carcinoma, Ductal, Breast, Receptors, Estrogen (for ER-positive Requirement)
- Trial name
- SIGNAL-ER 101 (NCT07214532)
- Testing
- ctDNA-Guided Treatment Strategy
- Where
- 49 sites in United States
- Volunteers
- 725 people
- Sponsor
- Natera, Inc.
Follicular Lymphoma, Diffuse Large B Cell Lymphoma
Optimizing ctDNA-based MRD Assessment in DLBCL, MCL, and FL Patients Undergoing CAR Therapy
In this study, invesigators propose to analyze 150 DLBCL patients, 50 MCL patients, and 100 FL patients to determine the clinical utility of ctDNA- as well as circulating tumor cell (CTC)-based MRD assessment in CAR therapy…
- Conditions
- Follicular Lymphoma, Diffuse Large B Cell Lymphoma, Mantle Cell Lymphoma
- Trial name
- NCT05255354
- Testing
- ClonoSEQ
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- Adaptive Biotechnologies
Breast Cancer, TNBC - Triple-Negative Breast Cancer
Evaluating Minimal Residual Disease (MRD) Through Longitudinal Circulating Tumor DNA (ctDNA) Profiling in Breast Malignancies
For patients with breast cancer, it's important to find any remaining cancer cells after they've had their main treatment. Even a few cells, called minimal residual disease (MRD), can lead to the cancer coming back later.
- Conditions
- Breast Cancer, TNBC - Triple-Negative Breast Cancer, HR Positive/HER-2 Negative Breast Cancer, HER2 + Breast Cancer
- Trial name
- GEMINI Breast (NCT07211178)
- Testing
- There are no interventions in this observational study.
- Where
- 16 sites in United States
- Volunteers
- 900 people
- Sponsor
- Tempus AI
Colorectal Cancer
A Study to Assess Adverse Events and Change in Disease Activity in Adult Participants Receiving Intravenously Infused Telisotuzumab Adizutecan Alone or With Standard of Care in Participants With Post Adjuvant Circulating Tumor DNA Positive Colorectal Cancer and No Radiographic Evidence of Disease
Colorectal cancer (CRC) is the third most common type of cancer diagnosed worldwide. The purpose of this study is to assess change in disease activity when telisotuzumab adizutecan is given alone compared to standard of care…
- Trial name
- NCT07023289
- Testing
- Telisotuzumab Adizutecan, Standard of Care
- Where
- 48 sites in United States, Belgium and 6 more
- Volunteers
- 140 people
- Sponsor
- AbbVie
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
Pancreatic Ductal Adenocarcinoma, Colorectal Cancer
A Study of ELI-002 7P in Subjects With KRAS/NRAS Mutated Solid Tumors
This is a Phase 1/2 study to assess the safety and efficacy of ELI-002 7P immunotherapy (a lipid-conjugated immune-stimulatory oligonucleotide [Amph-CpG-7909] plus a mixture of lipid-conjugated peptide-based antigens…
- Conditions
- Pancreatic Ductal Adenocarcinoma, Colorectal Cancer, KRAS G12D, KRAS G12R
- Trial name
- AMPLIFY-7P (NCT05726864)
- Testing
- ELI-002 7P
- Where
- 28 sites in United States
- Volunteers
- 158 people
- Sponsor
- Elicio Therapeutics
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.
Non Small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer
Analysis of Circulating Tumor DNA Dynamics to Predict and Monitor Response to TKI in Patients With Advanced NSCLC.
This is an observational study, aiming to investigate whether the ctDNA dynamics analyzed by the K-TrackTM assay could predict early response to Tyrosine kinase inhibitors (TKIs) in patients with advanced non-small cell lung…
- Conditions
- Non Small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer, Stage IIIC Non-Small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer
- Trial name
- NCT06167460
- Where
- Vietnam
- Volunteers
- 50 people
- Sponsor
- Gene Solutions
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
Cancer, Solid Tumor
MRD Assay Evaluates Recurrence and Response Via a Tumor Informed Assessment
This study recruits patient with solid tumor types for sample collection and monitoring. Participants will provide blood and archival tissue samples in order to create a Personalized Cancer Monitoring (PCM) assay.
- Conditions
- Cancer, Solid Tumor, Non Small Cell Lung Cancer, Colorectal Cancer
- Trial name
- MARIA (NCT05219734)
- Testing
- Personalized Cancer Monitoring (PCM)
- Where
- 2 sites in United States
- Volunteers
- 400 people
- Sponsor
- Invitae Corporation
NSCLC (Non-small Cell Lung Cancer), Squamous Lung Cancer With FGFR1 Amplification
Clinical Study of the Therapeutic Effectiveness of In-silico-Designed, Machine Learning Inspired, and Quantum-molecularly Coupled Personalized Neoantigenic Vaccines Microlyvaq™ in Patients With Advanced Non-small Cell Lung Cancer
Microlyvaq™ is a first-line, non-randomized, two-arm clinical trial in advanced non-small cell lung cancer (NSCLC). In both arms, patients receive a personalized multi-epitope vaccine (Microlyvaq™) on top of standard-of-care…
- Conditions
- NSCLC (Non-small Cell Lung Cancer), Squamous Lung Cancer With FGFR1 Amplification, Non-Squamous Non Small Cell Lung Cancer
- Trial name
- Microlyvaq™ (NCT07285434)
- Testing
- Microlyvaq™ (Personalized Multi-Epitope Immunotherapeutic)
- Where
- Greece
- Volunteers
- 90 people
- Sponsor
- Biogenea Pharmaceuticals Ltd.
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.
Rectal Cancer, Rectal Cancer Stage II
ctDNA Monitoring to Predict the Efficacy of TNT for Rectal Cancer
This is a prospective observational study with three primary objectives: Objective 1: Evaluate the detection rate and changes in circulating tumor DNA (ctDNA) levels in blood samples from colorectal cancer patients before…
- Conditions
- Rectal Cancer, Rectal Cancer Stage II, Rectal Cancer Stage III
- Trial name
- NCT06589388
- Where
- Vietnam
- Volunteers
- 100 people
- Sponsor
- Gene Solutions
Colorectal Cancer
Zanzalintinib Alone or in Combination With Pembrolizumab and Berahyaluronidase Alfa in Participants With Colorectal Cancer With Molecular Residual Disease
The primary objective of this study is to evaluate the effectiveness of zanzalintinib + Pembrolizumab (+) berahyaluronidase alfa and zanzalintinib alone compared with placebo.
- Trial name
- STELLAR-316 (NCT07750158)
- Testing
- Zanzalintinib, Pembrolizumab (+) Berahyaluronidase alfa
- Where
- 13 sites in United States
- Volunteers
- 600 people
- Sponsor
- Exelixis
Gastric-Esophageal Cancer
Signatera-Guided De-escalation of Adjuvant Therapy in Resectable Stage II-IVa Gastric/Gastric-Esophageal Cancer
The goal of this clinical trial is to assess if circulating tumor DNA, as assessed by Signatera tumor-informed MRD assay, can guide de-escalation of adjuvant therapy in patients with resectable Stage II-IVa…
- Trial name
- SIGNAL GEC-101 (NCT07565857)
- Testing
- Signatera Genome ultra-sensitive ctDNA blood test
- Volunteers
- 1,000 people
- Sponsor
- Natera, Inc.