Response Efficacy of PD-1 and PD-L1 Inhibitors in Clinical Trials: A Systematic Review and Meta-Analysis.
Shixue Chen, Zhibo Zhang, Xuan Zheng...
https://pubmed.ncbi.nlm.nih.gov/33937012Actively Recruiting
Age: 18Years +
All Genders
ID07327489
Predicting Response to Immunotherapy From Analysis of Live Tumor Biopsies
Led by Elephas · Updated on 2026-01-08
2000
Participants Needed
8
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying how to predict the response to immunotherapy in patients with suspected or confirmed cancer by analyzing live tumor biopsies. This observational study focuses on collecting tumor tissue samples along with clinical and genomic data from patients undergoing biopsy or similar procedures as part of their routine medical care. The goal is to understand the tumor microenvironment, including immune cells, and compare lab results to actual clinical outcomes to improve immunotherapy approaches. Participants provide tumor specimens obtained during their standard biopsy procedures, with possible additional biopsy passes if clinically appropriate. The study collects these samples while preserving the three-dimensional tumor environment to observe how the tumor responds to potential immunotherapy outside the body. If patients have subsequent biopsies for their care, extra samples may also be collected for research. During the study, participants will have their clinical data and tumor samples analyzed to identify markers that predict how well they respond to immune checkpoint inhibitors. The study will last about 36 months from enrollment to completion. Researchers will monitor immune responses and tumor characteristics, using these insights to help guide future immunotherapy development.
CONDITIONS
Brief Title
Predicting Response to Immunotherapy From Analysis of Live Tumor Biopsies
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Able and willing to provide informed consent for participation
- Age 18 years or older at time of consent
- Have a suspected or confirmed cancer diagnosis to be evaluated by biopsy
- Newly diagnosed or suspected cancer patients must be treatment-nafve at time of biopsy
- Other patients must have biopsy before starting their next line of treatment
You will not qualify if you...
- Known autoimmune disease or prior conditions making immunotherapy unsuitable (e.g., organ transplant, chronic kidney or liver disease)
- Severely immunocompromised individuals, including those on immunosuppressants, HIV positive on antiretrovirals, or post transplantation
- Pregnant individuals
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Occurs at time of routine care biopsy
Participants undergo biopsy procedures as part of their standard medical management or diagnostic work-up to collect tumor tissue samples for research.
1 or more biopsy procedures depending on clinical care
Long-term Monitoring
Duration - Approximately 36 months
Participants' tumor specimens and clinical data are analyzed to predict response to immunotherapy and study tumor characteristics over approximately 36 months from enrollment.
No additional visits; data collected from clinical records and specimens
Trial Site Locations
Total: 8 locations
1
Mercy Hospital - FTS
Fort Smith, Arkansas, United States, 72903
Actively Recruiting
2
Frederick Health Hospital
Frederick, Maryland, United States, 21702
Actively Recruiting
3
Mercy Hospital - SPG
Springfield, Missouri, United States, 65804
Actively Recruiting
4
Mercy Hospital - South
St Louis, Missouri, United States, 63128
Actively Recruiting
5
Mercy Hospital -STL
St Louis, Missouri, United States, 63141
Actively Recruiting
6
Mercy Hospital - OKC
Oklahoma City, Oklahoma, United States, 73120
Actively Recruiting
7
JPS Health Network
Forth Worth, Texas, United States, 76104
Actively Recruiting
8
Baylor Scott and White Biorepository
Temple, Texas, United States, 76508
Not Yet Recruiting
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How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Published Research Related To This Trial
Tissue sampling in the era of precision medicine: comparison of percutaneous biopsies performed for clinical trials or tumor genomics versus routine clinical care.
Anjuli R Cherukuri, Meghan G Lubner, Ryan Zea...
https://pubmed.ncbi.nlm.nih.gov/30032384