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

NCT03719222 | Unknown

• 1 other identifier: ACTG-18001
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Sequence Analysis

Keywords

Genomic profiling assay

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Single point mutations, as part of cancer genomic profile

  12 months

• Small insertions and deletions (Indel), as part of cancer genomic profile

  12 months

• Copy number alterations, as part of cancer genomic profile

  12 months

• Microsatellite instability, as part of genomic profile

  12 months

• TME gene expression profile, which consists of quantitative measurements of immune-related genes

  12 months

Interventions

non intervention OTHER

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Unusable sample or biologically deteriorated.

Sponsors & Collaborators

• ACT Genomics: lead
• Chi Mei Medical Hospital: collaborator

Study Sites (1)

ACT Genomics

Taipei, 114, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Archived paraffin-embedded tumor specimens

Central Study Contacts

ACT Genomics ACT Genomics

CONTACT

+886-2-2795-3660; peifangchung@actgenomics.com

Pei-Fang Chung

CONTACT

+886-2-2795-3660

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2018
• First Posted: October 25, 2018
• Study Start: September 26, 2018
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: October 29, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)