Assessing Systemic Treatment and ctDNA Monitoring Efficacy in Metastatic Cancer Patients Using K4Care Testing.

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorGene Solutions

About this trial

The goal of this observational study is to investigate the real-world treatment landscape of patients with metastatic cancer and determine the role of ctDNA in monitoring treatment response in patients with metastatic cancer who have undergone K4Care testing

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

Patients with metastatic cancer who have had tumor tissue sequencing and have genetic mutation data from the K4Care test at Gene Solutions between \[month/year\] and \[month/year\], who consent to participate in the study and allow the use of their clinical and sequencing data for future research purposes, will be included. These patients will also receive free ctDNA monitoring using the K-Track N assay for 12 months.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

This study aims to evaluate the correlation between ctDNA clearance and treatment response in metastatic cancer:

* ctDNA clearance during and after treatment will reflect the patient's response to the treatment regimen. * Persistent positive ctDNA during and after treatment will reflect the patient's non-response to the treatment regimen and disease progression. According to current scientific reports, this correlation is independent of cancer type and treatment regimen. Moreover, this is a preliminary, observational, and descriptive statistical study. The sample size for each cancer type depends on the actual number of patients tested at Gene Solutions. Therefore, this study is not limited to a specific cancer type; all patients with metastatic cancer will be included in the analysis (similar to others design. With an average treatment response rate in the metastatic stage of 10-50%, a sample size of 200 patients will allow us to collect data for at least 20 patients.

Time frame
18 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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Gene Solutions

Lead sponsor

The Medical Genetics Institute (MGI) of HCMC

Collaborator