Early circulating tumor DNA dynamics as a pan-tumor biomarker for long-term clinical outcome in patients treated with durvalumab and tremelimumab.
Maya Kansara, Neeru Bhardwaj, Subotheni Thavaneswaran...
https://pubmed.ncbi.nlm.nih.gov/36426653Actively Recruiting
All Genders
ID06929910
Evaluation of Systemic Therapy and the Effectiveness of Circulating Tumor DNA (ctDNA) Assays in Monitoring Treatment Response in Patients With Metastatic Cancer Undergoing K4Care Testing
Led by Gene Solutions · Updated on 2025-07-16
200
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
Sponsors
G
Gene Solutions
Lead Sponsor
T
The Medical Genetics Institute (MGI) of HCMC
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 collected—one at enrollment and another during a follow-up visit 3 to 6 months later or as per the participant's 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
Brief Title
Assessing Systemic Treatment and ctDNA Monitoring Efficacy in Metastatic Cancer Patients Using K4Care Testing.
Who Can Participate
All Genders
Eligibility Criteria
You may qualify if you...
- Pathological and imaging confirmation of metastatic or progressive stage IV cancer.
- Consent to the use of their clinical data.
- Diagnosis of one of the following common solid tumor types: lung, colorectal, breast, gastric, or cancer of unknown primary origin.
- Prior K4Care testing to identify tumor tissue (FFPE) mutations and consent to the use of their sequencing data.
You will not qualify if you...
- Refusal to participate in the study.
- Absence of prior K4Care testing.
- Diagnosis of early-stage cancer or hematologic malignancy.
- Refusal to provide clinical information or blood samples.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Monitoring
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
Trial Site Locations
Total: 1 location
1
Medical Genetics Institute
Ho Chi Minh City, Hồ Chí Minh, Vietnam
Actively Recruiting
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Research Team
S
Sinh D Nguyen, PhD. MD
L
Lan N Tu, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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