NCT06227728 Analysis of PD-L1, TMB, MSI and ctDNA Dynamics to Predict and Monitor Response to Immunotherapy in Metastatic Cancer.
| NCT ID | NCT06227728 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Gene Solutions |
| Condition | Non Small Cell Lung Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-03-22 |
| Primary Completion | 2026-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2024-03-22 with a primary completion date of 2026-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is an observational clinical trial, aiming to investigate whether the ctDNA dynamics could predict early response to ICIs in patients with advanced-stage cancer. Moreover, conventional tumor markers PD-L1, TMB and MSI are to be investigated for their combined prognostic values in ICI treatment.
Eligibility Criteria
Inclusion Criteria: * 18 years and older, both genders. * Patients are diagnosed with stage IV cancer (lung, colorectal, breast, liver, gastric…) and indicated for ICI (first or second line). Concurrent chemotherapy with ICI is allowed. * FFPE/FNA sample is available. * Compliant with treatment protocol. * Patients consented to participate in the study. Exclusion Criteria: * Patients already started ICI before enrollment. * Consolidation ICI (eg. Durvalumab). * Patients already started chemotherapy before enrollment. * Medical or psychiatric conditions or occupational responsibilities that may preclude compliance with the protocol. * Patients did not agree to participate in the studies.
Contact & Investigator
Sinh D Nguyen
PRINCIPAL INVESTIGATOR
MGI
Frequently Asked Questions
Who can join the NCT06227728 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Non Small Cell Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06227728 currently recruiting?
Yes, NCT06227728 is actively recruiting participants. Contact the research team at lantu@genesolutions.vn for enrollment information.
Where is the NCT06227728 trial being conducted?
This trial is being conducted at Ho Chi Minh City, Vietnam, Ho Chi Minh City, Vietnam.
Who is sponsoring the NCT06227728 clinical trial?
NCT06227728 is sponsored by Gene Solutions. The principal investigator is Sinh D Nguyen at MGI. The trial plans to enroll 50 participants.
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