Tumor Mutation Burden as a Biomarker in Resected Non-Small-Cell Lung Cancer.
Siddhartha Devarakonda, Federico Rotolo, Ming-Sound Tsao...
https://pubmed.ncbi.nlm.nih.gov/30106638/Actively Recruiting
Led by Gene Solutions · Updated on 2025-07-16
200
Participants Needed
1
Research Sites
25 weeks
Total Duration
Researchers are investigating the treatment landscape for patients with metastatic cancer, focusing on the role of circulating tumor DNA ctDNA in monitoring how these patients respond to their treatments. This observational, prospective, and longitudinal study collects data from patients who have undergone K4Care testing between March 2025 and March 2026. The study aims to better understand how ctDNA levels relate to cancer progression and treatment effectiveness. Participants will have two blood samples collectedone at enrollment and another during a follow-up visit 3 to 6 months later or as per the participants follow-up schedule. Clinical information including demographics, medical history, cancer diagnosis details, treatment regimens like surgery or chemotherapy, and imaging results will be gathered from patient records. The study also records important clinical outcomes such as tumor response, progression, and survival status. During the study, researchers will assess ctDNA clearance and its correlation with treatment response over 18 months. Patient assessments involve imaging like CT or MRI scans, physician evaluations of disease status, and collection of blood samples for ctDNA analysis. The study monitors progression-free survival and overall survival while collecting comprehensive clinical and pathological data to understand the relationship between ctDNA and cancer treatment outcomes.
CONDITIONS
Assessing Systemic Treatment and ctDNA Monitoring Efficacy in Metastatic Cancer Patients Using K4Care Testing.
S
Sinh D Nguyen, PhD. MD
L
Lan N Tu, PhD
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Gene Solutions
Lead Sponsor
The Medical Genetics Institute (MGI) of HCMC
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 18 months
Participants who have undergone K4Care testing are observed through collection of clinical data and blood samples to evaluate treatment response and disease progression.
2 visits for blood sample collection; clinical information collected during routine follow-up visits as scheduled by physicians
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
Have more questions? Get in touch with our team for quick support
Siddhartha Devarakonda, Federico Rotolo, Ming-Sound Tsao...
https://pubmed.ncbi.nlm.nih.gov/30106638/Scott V Bratman, S Y Cindy Yang, Marco A J Iafolla...
https://pubmed.ncbi.nlm.nih.gov/35121950/Dario de Biase, Matteo Fassan, Umberto Malapelle
https://pubmed.ncbi.nlm.nih.gov/33212911/Dejene Tolossa Debela, Seke Gy Muzazu, Kidist Digamo Heraro...
https://pubmed.ncbi.nlm.nih.gov/34408877/Uttpal Anand, Abhijit Dey, Arvind K Singh Chandel...
https://pubmed.ncbi.nlm.nih.gov/37397557/Sreyashi Das, Mohan Kumar Dey, Ram Devireddy...
https://pubmed.ncbi.nlm.nih.gov/38202898/Sian L Shuel
https://pubmed.ncbi.nlm.nih.gov/35831091/Maya Kansara, Neeru Bhardwaj, Subotheni Thavaneswaran...
https://pubmed.ncbi.nlm.nih.gov/36426653/L Cabel, F Riva, V Servois...
https://pubmed.ncbi.nlm.nih.gov/28459943/Alexandra Kavun, Egor Veselovsky, Alexandra Lebedeva...
https://pubmed.ncbi.nlm.nih.gov/37190216/Gene Solutions
Lead Sponsor
The Medical Genetics Institute (MGI) of HCMC
Collaborating Sponsor