Analysis of Tumor Mutations and Tumor Microenvironment Using Archival Paraffin-embedded Tumor Specimens
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Sequence Analysis
- Sponsor
- ACT Genomics
- Enrollment
- 600
- Locations
- 1
- Primary Endpoint
- Correlation between TMB and the expression level of PD-1/PD-L1
- Last Updated
- 7 years ago
Overview
Brief Summary
Genomic alterations have long been recognized as an important factor in tumor formation and drive tumor cell growth. However, the degree of genomic mutation (tumor mutation load, TMB) varies widely between tumors. In addition to gene mutations in tumor cells, the extent of immune cell infiltration in tumor tissues and the type and nature of immune cells (tumor microenvironment, TME) also play an important role in controlling tumor growth.
In recent years, more and more clinical studies have shown that the degree of genomic alteration (TMB) and tumor microenvironment (TME) have great potential in predicting a cancer patients' response to immunotherapy. Therefore, understanding the interaction and correlation between genomic alteration and tumor immune environment will not only deepen our understanding of tumor biology but also provide an important reference for developing immunotherapy treatment strategies for solid tumors.
Detailed Description
This is a non-interventional, mono-centric retrospective study to be carried out in Chi Mei Medical Center (CMMC) in order to determine the association between the genomic alterations and gene expression level of immune-related genes in cancer. Samples in paraffin-embedded block of biopsies or surgical pieces (either primary tumor or metastases) will be analyzed. For each sample, clinically relevant data associated with treated cancer and needed for characterization of tumor microenvironment will be documented. No additional procedures besides those already used in the routine clinical practice will be applied to the patients. Treatment assignment will be done according to the current practice. This trial is, through accessing to archival tumor materials, to establish the relationship between tumor mutation burden and tumor immune microenvironment for future immunotherapy strategy.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Sample from patients with histologically documented cancer in target population.
Exclusion Criteria
- •Unusable sample or biologically deteriorated.
Outcomes
Primary Outcomes
Correlation between TMB and the expression level of PD-1/PD-L1
Time Frame: 12 months
To explore possible relationship between genomic alteration and expression of immune-related genes in solid tumor, tumor mutation burden (TMB) and PD-1/PD-L1 expression level are examined and such relationship will be calculated by Pearson's correlation coefficient.
Secondary Outcomes
- TME gene expression profile, which consists of quantitative measurements of immune-related genes(12 months)
- Copy number alterations, as part of cancer genomic profile(12 months)
- Concordance of TMB between ACTOnco assay and an externally validated assay(12 months)
- Single point mutations, as part of cancer genomic profile(12 months)
- Small insertions and deletions (Indel), as part of cancer genomic profile(12 months)
- Microsatellite instability, as part of genomic profile(12 months)