Systemic treatment and ctDNA monitoring with K4Care for people with metastatic cancer
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
This project will test whether tracking ctDNA with K4Care can help monitor treatment response in people with metastatic lung, colorectal, breast, gastric, or unknown primary cancers.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Sex | All |
| Sponsor | Gene Solutions Industry-sponsored |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Ho Chi Minh City, Hồ Chí Minh) |
| Trial ID | NCT06929910 on ClinicalTrials.gov |
What this trial studies
This is a prospective, longitudinal, non-interventional cohort of patients with pathologically and radiologically confirmed metastatic (stage IV) solid tumors who previously underwent K4Care tumor sequencing. Participants will provide blood samples and clinical data between March 2025 and March 2026 while receiving usual systemic therapy, and circulating tumor DNA (ctDNA) levels will be measured from plasma cfDNA. The study will relate changes in ctDNA and mutation allele fraction to clinical outcomes such as progression-free survival and overall survival. Data are collected in a real-world clinical setting at the Medical Genetics Institute in Ho Chi Minh City using prior K4Care sequencing results to link tissue mutations with plasma signals.
Who should consider this trial
Good fit: Adults with pathologic and imaging confirmation of metastatic (stage IV) lung, colorectal, breast, gastric, or cancer of unknown primary who previously had K4Care tumor sequencing and consent to share clinical data and provide blood samples.
Not a fit: Patients with early-stage disease, hematologic malignancies, no prior K4Care testing, or those who refuse blood draws or data sharing are unlikely to benefit from this project.
Why it matters
Potential benefit: If successful, routine ctDNA monitoring could provide earlier signals of treatment failure and help guide more timely changes in systemic therapy for metastatic cancer patients.
How similar studies have performed: Prior research has shown promise for ctDNA as a marker of treatment response and minimal residual disease, but prospective, real-world cohorts linking K4Care tissue results with serial plasma monitoring remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Where this trial is running
Ho Chi Minh City, Hồ Chí Minh
- Medical Genetics Institute — Ho Chi Minh City, Hồ Chí Minh, Vietnam (Recruiting)
Study contacts
- Study coordinator: Sinh D Nguyen, PhD. MD
- Email: sinhnguyen@genesolutions.vn
- Phone: +84 834105425
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.