Clinical trials: ctDNA
HER2-positive Breast Cancer, Metastatic Cancer
PRE-ISPY Phase I/II Oncology Platform Program
PRE-ISPY Phase I/II (I-SPY-P1) is an open-label, multisite platform study with multiple ongoing drug regimen arms added by protocol amendment which is designed to evaluate single agents or combinations in locally advanced…
- Conditions
- HER2-positive Breast Cancer, Metastatic Cancer, Metastatic Breast Cancer, Metastatic
- Trial name
- PRE-ISPY (NCT05868226)
- Testing
- ALX148, Fam-Trastuzumab Deruxtecan-Nxki, Zanidatamab
- Where
- 10 sites in United States
- Volunteers
- 280 people
- Sponsor
- QuantumLeap Healthcare Collaborative
Minimal Residual Disease, Adjuvant Chemotherapy
A Phase 2 Trial of Fruquintinib and Tislelizumab in ctDNA-defined Minimal Residual Disease in Colorectal Cancer After Completion of Adjuvant Chemotherapy
To find out if a combination of fruquintinib and tislelizumab can control CRC in patients who have received treatment for the disease but still have "positive" ctDNA tests for MRD (meaning there is evidence of MRD based on this…
- Conditions
- Minimal Residual Disease, Adjuvant Chemotherapy, Colorectal Cancer, Fruquintinib
- Trial name
- NCT07136077
- Testing
- Tislelizumab, Fruquintinib
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- M.D. Anderson Cancer Center
Liver Metastasis Colon Cancer, ctDNA Genotype
Targeted Treatment Plus Tislelizumab and HAIC for Advanced CRCLM Failed From Standard Systemic Treatment
Hepatic arterial infuison chemothearpy (HAIC), targeted therapy, and programmed death-1 (PD-1) inhibitors have been demonstrated to be effective for colorectal cancer liver metastasis (CRCLM).
- Conditions
- Liver Metastasis Colon Cancer, ctDNA Genotype, MSS, Failed From Standard Treatment
- Trial name
- NCT06199232
- Testing
- HAIC+targeted therapy+PD-1 inhibitor
- Where
- China
- Volunteers
- 47 people
- Sponsor
- Peking University
Hormone Receptor-Positive Breast Cancer, High-risk Breast Cancer
ctDNA-Guided De-Escalation of Adjuvant Chemotherapy With Dalpiciclib in HR-Positive/HER2-Negative Breast Cancer
This is a Phase II, multicenter, randomized clinical trial evaluating a ctDNA-guided approach to de-escalate adjuvant chemotherapy in patients with hormone receptor (HR)-positive, HER2-negative early-stage breast cancer.
- Conditions
- Hormone Receptor-Positive Breast Cancer, High-risk Breast Cancer, Early-Stage Breast Cancer, HER2-negative Breast Cancer
- Trial name
- DNADalHR (NCT06970912)
- Testing
- Dalpiciclib + Aromatase Inhibitor with ctDNA-Guided Therapy, Taxane-Based Neoadjuvant Chemotherapy
- Where
- China
- Volunteers
- 393 people
- Sponsor
- Peking University People's Hospital
Hormone Receptor-Positive Breast Cancer, High-risk Breast Cancer
CDK4/6 Inhibitors Combined With Endocrine Therapy for Neoadjuvant Treatment
Exploring the dynamics of ctDNA following neoadjuvant therapy with CDK4/6 inhibitors combined with endocrine treatment, and its potential to guide de-escalation of adjuvant chemotherapy
- Conditions
- Hormone Receptor-Positive Breast Cancer, High-risk Breast Cancer, Early-Stage Breast Cancer, HER2-negative Breast Cancer
- Trial name
- DNACDKHR (NCT07366112)
- Testing
- CDK4/6 inhibitor with endocrine therapy
- Where
- China
- Volunteers
- 158 people
- Sponsor
- Peking University People's Hospital
Colorectal Cancer, Liver Metastases
French Assessment of MRD by Liquid Biopsies in Colorectal With Liver Metastasis Patients (FRENCH.MRD.CRLM)
Improving personalized cancer treatments and finding the best strategies to treat each patient relies on using new diagnostic technologies.
- Conditions
- Colorectal Cancer, Liver Metastases, Stage IV Colorectal Cancer, Minimal Residual Disease
- Trial name
- NCT06287723
- Testing
- Blood sample/Liquid biopsy
- Where
- 2 sites in France
- Volunteers
- 30 people
- Sponsor
- University Hospital, Montpellier
ctDNA, Chemotherapy
A Randomized Controlled Trial of Plasma ctDNA Methylation-Guided Adjuvant Chemotherapy Decision-Making in High-Risk Stage III (T4N+ or T1-3N2) Colorectal Cancer
Patients with T4N+ or T1-3N2 disease will be randomly assigned to either the control group (FOLFOX/CAPOX for 6 months) or the intervention group (FOLFOX/CAPOX plus bevacizumab for 6 months) to receive adjuvant therapy.
- Conditions
- ctDNA, Chemotherapy, Colorectal Cancer
- Trial name
- CLEAR-04 (NCT07562490)
- Testing
- FOLFOX, Folfox plus Bevacizumab
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Fudan University
ctDNA, Colorectal Cancer
Randomized Trial of Plasma ctDNA Methylation-Guided Adjuvant Therapy in T4N0 and Low-Risk Stage III Colorectal Cancer
The patient (T4N0 or low-risk stage III) will be randomly assigned to either the control group (FOLFOX/CAPOX for 3 months) or the intervention group (FOLFOX/CAPOX for 6 months or FOLFOX/CAPOX for 3 months followed by…
- Conditions
- ctDNA, Colorectal Cancer, Chemotherapy
- Trial name
- CLEAR-03 (NCT07562503)
- Testing
- CAPEOX regimen
- Where
- China
- Volunteers
- 340 people
- Sponsor
- Fudan University
ctDNA, Colorectal Cancer (CRC)
Randomized Controlled Study of Plasma ctDNA Methylation-Guided Adjuvant Chemotherapy in Stage I/Low-Risk Stage II Colorectal Cancer
This study will utilize ctDNA methylation detection to evaluate patients with stage I or low-risk stage II colorectal cancer who are ctDNA-positive one month after surgery.
- Conditions
- ctDNA, Colorectal Cancer (CRC), Adjuvant Chemotherapy
- Trial name
- CLEAR-01 (NCT07562659)
- Testing
- Capecitabine
- Where
- China
- Volunteers
- 80 people
- Sponsor
- Fudan University
ctDNA, Chemotherapy
Randomized Study of Plasma ctDNA Methylation to Guide Adjuvant Chemotherapy Decisions in High-Risk T3N0 Colorectal Cancer
This study will utilize ctDNA methylation detection to evaluate patients with high-risk T3N0 stage II colorectal cancer who are ctDNA-positive one month after surgery.
- Conditions
- ctDNA, Chemotherapy, Colorectal Cancer
- Trial name
- CLEAR-02 (NCT07562711)
- Testing
- Capecitabine, FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)
- Where
- China
- Volunteers
- 340 people
- Sponsor
- Fudan University
Colorectal Cancer, Colo-rectal Cancer
ctDNA-guided Surveillance for Stage III CRC, a Randomized Intervention Trial
IMPROVE-IT2 is a randomized multicenter trial comparing the outcomes of ctDNA guided post-operative surveillance and standard-of-care CT-scan surveillance.
- Conditions
- Colorectal Cancer, Colo-rectal Cancer, ctDNA, Gastro-Intestinal Disorder
- Trial name
- NCT04084249
- Testing
- ctDNA-analysis, Intensified Follow-up Schedule
- Where
- 10 sites in Denmark
- Volunteers
- 359 people
- Sponsor
- Claus Lindbjerg Andersen
Molecular Surveillance, Breast Cancer
Molecular Surveillance In Early Breast Cancer Using The Tumor-Informed ctDNA Assay Myriad Genetics Precise MRD Test; A Prospective Observational Multicenter Study (The MRD Molecular Surveillance Study)
To learn about changes in ctDNA during the diagnosis, treatment, and post-treatment surveillance of EBC.
- Conditions
- Molecular Surveillance, Breast Cancer, ctDNA, MRD
- Trial name
- NCT07475923
- Testing
- Blood draw for the laboratory assessment, Neoadjuvant treatment
- Sponsor
- M.D. Anderson Cancer Center
ctDNA, Gastric Cancer
Dynamic ctDNA-Guided Adjuvant Therapy in cStage III and IVA Gastric or Gastroesophageal Junction Adenocarcinoma
This is a single-center, prospective, exploratory study evaluating the use of dynamic circulating tumor DNA (ctDNA) monitoring in the postoperative adjuvant treatment setting for patients with stage III or stage IVA gastric or…
- Conditions
- ctDNA, Gastric Cancer, Gastroesophageal Junction (GEJ) Adenocarcinoma, Adjuvant Treatment
- Trial name
- NCT07507916
- Testing
- HLX10, SOX Chemotherapy
- Volunteers
- 32 people
- Sponsor
- Fudan University
Esophageal Cancer, ctDNA
A Multicenter Prospective Study Evaluating Concurrent Chemoradiotherapy Following Induction Immunochemotherapy for Esophageal Cancer Based on Dynamic ctDNA Monitoring
Esophageal squamous cell carcinoma (ESCC) continues to exhibit high incidence and mortality rates in China, with the majority of patients diagnosed at middle to advanced stages.
- Trial name
- NCT06792786
- Testing
- Induction Immunochemotherapy
- Where
- 2 sites in China
- Volunteers
- 30 people
- Sponsor
- The Central Hospital of Lishui City
Triple Negative Breast Cancer, Surveillance
Early Detection of Metastatic Recurrence Among Patients With Stage II or III Triple Negative Breast Cancer Using Liquid Biopsy and Imaging
Triple-negative breast cancer (TNBC) is an aggressive type of breast cancer, often with poor outcomes. Currently, follow-up for TNBC consists of physical exams and annual breast imaging, with additional scans only if symptoms…
- Conditions
- Triple Negative Breast Cancer, Surveillance, Recurrence, ctDNA
- Trial name
- EINSTEIN-TNBC (NCT07478705)
- Testing
- ctDNA-guided imaging surveillance, Standard
- Volunteers
- 30 people
- Sponsor
- Sunnybrook Health Sciences Centre
Metastatic Breast Cancer ( HER2 Negative), ctDNA
ctDNA-guided Treatment Decision-making
This is an exploratory, ctDNA-guided, multi-stage clinical study designed to evaluate the clinical value of treatment decision-making based on circulating tumor DNA (ctDNA) variant allele frequency (VAF) dynamics in patients with…
- Trial name
- NCT07394218
- Testing
- ADC, Ivonescimab
- Where
- China
- Volunteers
- 122 people
- Sponsor
- Fudan University
Esophageal Cancer, MRD
Based on ctDNA-MRD Guided Adjuvant Treatment Escalation After Definitive Chemoradiotherapy for Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma: a Study on Safety and Efficacy
Numerous studies have confirmed that ctDNA-MRD detection technology based on peripheral blood can identify minimal residual disease (MRD) following surgery and other curative treatments, indicating a higher risk of recurrence.
- Conditions
- Esophageal Cancer, MRD, ctDNA
- Trial name
- NCT07371247
- Testing
- Step-up therapy, Standard treatment Routine treatment
- Where
- China
- Volunteers
- 65 people
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
Colorectal Cancer (Diagnosis), Colorectal Liver Metastasis (CRLM)
Feasibility of Circulating Tumour DNA (ctDNA) Analysis Using Automated Capillary Blood Sampling
The goal of this observational study is to investigate whether circulating tumor-derived DNA (ctDNA) can be reliably detected and analyzed in blood obtained through automated capillary sampling in adult patients (≥21 years) with…
- Conditions
- Colorectal Cancer (Diagnosis), Colorectal Liver Metastasis (CRLM), Circulating Tumor DNA (ctDNA)
- Trial name
- ctDNA TAP (NCT07310537)
- Testing
- Blood Collection - TAP® Device, Blood Collection - Venous
- Where
- Netherlands
- Volunteers
- 35 people
- Sponsor
- Erasmus Medical Center
ctDNA Monitoring, Breast Cancer
Abemaciclib for Molecular Residual Disease Detected by Circulating Tumor DNA in HR+/HER2- Early Breast Cancer
The goal of this clinical study is to determine whether monitoring ctDNA and treating patients who become ctDNA-positive with abemaciclib can help prevent the recurrence of hormone receptor-positive, HER2-negative breast cancer…
- Trial name
- ARCHE (NCT07292207)
- Testing
- Abemaciclib 150 MG Oral Tablet
- Where
- Japan
- Volunteers
- 30 people
- Sponsor
- Nagoya City University
Metastatic Colorectal Cancer ctDNA Surveillance
Using ctDNA Methylation to Monitor Metastatic Colorectal Cancer Treatment (PROMET)
Multi-center observational clinical study to evaluate the application value of ctDNA methylation monitoring in efficacy assessment and relapse prediction in patients diagnosed with recurrence or metastatic colorectal cancer…
- Trial name
- NCT07283575
- Testing
- Plasma ctDNA methylation profiling
- Where
- China
- Volunteers
- 497 people
- Sponsor
- Fudan University