Analysis of PD-L1, TMB, MSI and ctDNA Dynamics to Predict and Monitor Response to Immunotherapy in Metastatic Cancer.
Recruiting · NCT06227728 · Observational (researchers observe without assigning treatment) · Lead sponsor: Gene Solutions
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Age range
18 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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.
Where it is running
4 locations listed.
- Medical Genetics Institute - Ho Chi Minh City, Vietnam
- Medical Genetics Institute - Ho Chi Minh City, Vietnam
- University of Medicine and Pharmacy at HCMC - Ho Chi Minh City, Hồ Chí Minh, Vietnam
- University of Medicine and Pharmacy at HCMC - Ho Chi Minh City, Hồ Chí Minh, Vietnam