Clinical trial NCT03719222: Analysis of Tumor Mutations and Tumor Microenvironment Using Archival Paraffin-embedded Tumor Specimens
Official title: Analysis of Tumor Mutations and Tumor Microenvironment Using Archival Paraffin-embedded Tumor Specimens
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sequence Analysis
Keywords: Genomic profiling assay
Lead sponsor: ACT Genomics
Sponsor class: INDUSTRY
Collaborators: name: Chi Mei Medical Hospital
First posted: 2018-10-25
Enrollment: 600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 600 cancer patients who fulfill the eligibiltiy criteria will be selected from the CMMC tissue bank. Eligible patients should have an available archival paraffin-embedded tumor block stored at the Department of Pathology, CMMC.

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.

Eligibility criteria: Inclusion Criteria:

* Sample from patients with histologically documented cancer in target population.

Exclusion Criteria:

* Unusable sample or biologically deteriorated.

Primary outcomes:
measure: Correlation between TMB and the expression level of PD-1/PD-L1
timeFrame: 12 months
Secondary outcomes:
measure: Single point mutations, as part of cancer genomic profile
timeFrame: 12 months
measure: Small insertions and deletions (Indel), as part of cancer genomic profile
timeFrame: 12 months
measure: Copy number alterations, as part of cancer genomic profile
timeFrame: 12 months
measure: Microsatellite instability, as part of genomic profile
timeFrame: 12 months
measure: TME gene expression profile, which consists of quantitative measurements of immune-related genes
timeFrame: 12 months
measure: Concordance of TMB between ACTOnco assay and an externally validated assay
timeFrame: 12 months
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: ACT Genomics
Study officials:
References: