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

NCT06929910 | Recruiting

• 1 other identifier: GS_ZKM
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Metastatic Cancers

Keywords

ctDNA; metastatic cancer

Outcome Measures

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.

  18 months

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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.

You may qualify if:

• 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 may not qualify if:

• 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.

Sponsors & Collaborators

• Gene Solutions: lead
• The Medical Genetics Institute (MGI) of HCMC: collaborator

Study Sites (1)

Medical Genetics Institute

Ho Chi Minh City, Hồ Chí Minh, Vietnam

RECRUITING

Related Publications (12)

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  PMID: 28459943 BACKGROUND

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MeSH Terms

Conditions

Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Sinh D Nguyen, PhD. MD

CONTACT

+84 834105425; sinhnguyen@genesolutions.vn

Lan N Tu, PhD

CONTACT

lantu@genesolutions.vn

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2025
• First Posted: April 16, 2025
• Study Start: April 9, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: July 16, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Dec 2026
• Access Criteria: GS\ ZKM

Locations

VN (1)