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Analysis of PD-L1, TMB, MSI and ctDNA Dynamics to Predict and Monitor Response to Immunotherapy in Metastatic Cancer.
RECRUITINGSponsored by Gene Solutions
Actively Recruiting
SponsorGene Solutions
Started2024-03-22
Est. completion2026-12-01
Eligibility
Age18 Years – 80 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06227728
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
Age: 18 Years – 80 YearsHealthy volunteers accepted
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.
Conditions10
Advanced CancerBreast CancerCancerColorectal CancerGastric CancerImmune Checkpoint InhibitorLiver CancerLiver DiseaseLung CancerNon Small Cell Lung Cancer
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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.
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Actively Recruiting
SponsorGene Solutions
Started2024-03-22
Est. completion2026-12-01
Eligibility
Age18 Years – 80 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06227728