Analysis of Tumor Mutations and Tumor Microenvironment Using Archival Paraffin-embedded Tumor Specimens

Sequence Analysis Clinical Trial

Official title:

Analysis of Tumor Mutations and Tumor Microenvironment Using Archival Paraffin-embedded Tumor Specimens

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03719222
• Other study ID #: ACTG-18001
• Status: Recruiting
• Start date: September 26, 2018
• Est. completion date: September 2019

Study information

• Verified date: October 2018
• Source: ACT Genomics
• Contact: ACT Genomics ACT Genomics
• Phone: +886-2-2795-3660
• Email: peifangchung[@]actgenomics.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: September 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Unusable sample or biologically deteriorated.

Related Conditions & MeSH terms

• Sequence Analysis

Intervention

Other:
• non intervention
It is an non-interventional retrospective observational study by using archived paraffin-embedded tumor specimens

Locations

Country	Name	City	State
Taiwan	ACT Genomics	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
ACT Genomics	Chi Mei Medical Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between TMB and the expression level of PD-1/PD-L1	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.	12 months
Secondary	Single point mutations, as part of cancer genomic profile	To establish a cancer genomic profile for the Asian population, genomic alterations such as point mutations will be assessed by NGS-based ACTOnco assay.	12 months
Secondary	Small insertions and deletions (Indel), as part of cancer genomic profile	To establish a cancer genomic profile for the Asian population, genomic alterations such as small insertions and deletions will be assessed by NGS-based ACTOnco assay.	12 months
Secondary	Copy number alterations, as part of cancer genomic profile	To establish a cancer genomic profile for the Asian population, genomic alterations such as copy number alterations will be assessed by NGS-based ACTOnco assay.	12 months
Secondary	Microsatellite instability, as part of genomic profile	To establish a cancer genomic profile for the Asian population, genomic alterations such as microsatellite instability will be assessed by NGS-based ACTOnco assay.	12 months
Secondary	TME gene expression profile, which consists of quantitative measurements of immune-related genes	To establish an expression signature of tumor microenvironment (TME) in addition to PD-1 and PD-L1, >90 immune-related genes will be assessed by ACTTME assay via quantitative PCR	12 months
Secondary	Concordance of TMB between ACTOnco assay and an externally validated assay	To compare between calculated tumor mutation burden values (TMB, in mutations per megabase) resulting from different methodologies, concordance between two NGS-based assays will be expressed as positive predictive value (PPV) and negative predictive value (NPV).	12 months