How patient traits and sample handling affect PD-L1 test results on tumor biopsies
Evaluation of Patient Factors and Sample Pre-Analytics on Predictive Multiplex Immunohistochemical Assays in Immuno-Oncology Patients
This project looks at whether who you are and how your biopsy is handled can change PD-L1 test results that guide immunotherapy for cancers like lung, melanoma, bladder, and stomach.
Quick facts
| Grant type | U01 cooperative agreement |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Beth Israel Deaconess Medical Center NIH-funded |
| Lab location | 1 site (Boston, United States) |
| Project ID | NIH-11261628 on NIH RePORTER |
What this research studies
The team uses a new lab method that measures PD-L1 together with tissue- and cell-type markers on a single biopsy slide so less tissue is needed. They will compare PD-L1 readouts across samples that differ by patient factors (for example age, BMI, medications) and by how the tissue was collected and processed (biopsy size, time to fixation, handling). Researchers will use tumor biopsy samples from people treated for immuno-oncology cancers to see which pre-analytic issues can shift a PD-L1 result across the clinical cutoff. The goal is to find practical steps to make PD-L1 testing more reliable, especially for very small biopsy samples.
Who could benefit from this research
Good fit: Ideal candidates are people with solid tumors such as lung, melanoma, bladder, or gastroesophageal cancers who have tumor biopsies available or are undergoing biopsy for PD-L1 testing.
Not a fit: People without available tumor tissue, those with cancers not treated using PD-L1 biomarkers, or those unable to provide biopsy samples are unlikely to gain direct benefit from this work.
Why it matters
Potential benefit: If successful, the work could make PD-L1 testing more accurate so more patients get the right immunotherapy decisions from small biopsy samples.
How similar studies have performed: Standard PD-L1 IHC tests are widely used clinically, but combining multiplexed markers on one slide and systematically studying patient- and sample-related pre-analytic effects is relatively new and not yet fully validated.
Where this research is happening
Boston, United States
- Beth Israel Deaconess Medical Center — Boston, United States (Active)
Researchers
- Principal investigator: Wei, Wenyi — Beth Israel Deaconess Medical Center
- Study coordinator: Wei, Wenyi
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page below.