Analysis of PD-L1, TMB, MSI and ctDNA Dynamics to Predict and Monitor Response to Immunotherapy in Metastatic Cancer.
Launched by GENE SOLUTIONS · Jan 18, 2024
Trial Information
Current as of March 11, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at how changes in certain blood markers can help doctors predict how well patients with advanced-stage cancer respond to a type of treatment called immunotherapy. Specifically, the study will focus on a marker found in the blood called ctDNA, along with other markers related to tumors, to see if they can give early clues about a patient's response to treatment. The trial is currently recruiting patients diagnosed with stage IV cancers, such as non-small cell lung cancer, breast cancer, colorectal cancer, gastric cancer, and liver cancer, who are starting immunotherapy for the first or second time.
To participate, you need to be at least 18 years old and have a confirmed diagnosis of stage IV cancer that requires immunotherapy. You should also have a specific type of tissue sample available for testing. It’s important that you haven’t started immunotherapy or chemotherapy before joining the trial. If you decide to participate, you will be closely monitored throughout your treatment to see how your body responds. This trial may provide valuable information that could help improve treatment for future patients with advanced cancer.
Gender
ALL
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.
Trial Officials
Sinh D Nguyen
Principal Investigator
MGI
About Gene Solutions
Gene Solutions is a pioneering biotechnology company dedicated to advancing personalized medicine through innovative genomic solutions. Focused on harnessing the power of genetic insights, the company conducts cutting-edge clinical trials aimed at developing and validating diagnostic tools and therapeutic approaches. With a commitment to enhancing patient outcomes, Gene Solutions collaborates with leading research institutions and healthcare providers to explore novel treatments and improve the understanding of genetic predispositions. Their rigorous scientific methodology and dedication to ethical standards position them as a trusted leader in the field of genomics and precision health.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Ho Chi Minh City, , Vietnam
Ho Chi Minh City, Hồ Chí Minh, Vietnam
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0