Clinical trial Recruiting at 1 site Observational

Systemic treatment and ctDNA monitoring with K4Care for people with metastatic cancer

Official title: 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

Run by Gene Solutions · NCT06929910 · Data updated 2026-11-12

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.

More Metastatic Cancers trials

Quick facts

Study typeObservational
SexAll
Enrollment200 (estimated)
SponsorGene Solutions
Industry-sponsored
Drugs / interventionschemotherapy, immunotherapy
Locations1 site (Ho Chi Minh City, Hồ Chí Minh)
StatusRecruiting
StartedApril 9, 2025
Main results expectedDecember 31, 2026
Study endsJune 30, 2027
Registry record updatedJuly 16, 2025
Trial IDNCT06929910 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • Medical Genetics Institute
    Ho Chi Minh City, Hồ Chí Minh, Vietnam
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.