Sequence AnalysisNCT03719222
Analysis of Tumor Mutations and Tumor Microenvironment Using Archival Paraffin-embedded Tumor Specimens
An observational study of Sequence Analysis, run by ACT Genomics at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sequence Analysis
- What is being tested?
- non intervention
- How many people
- 600 participants
- Where
- 1 siteTaiwan
- Study dates
- 26 Sep 2018to Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Sample from patients with histologically documented cancer in target population.
Who cannot join
- Unusable sample or biologically deteriorated.
Trial locations and contacts
1 site in 1 country.
Pei-Fang Chung contact
Taiwan1 site, 1 recruiting
- Recruiting
ACT Genomics
Taipei, 114
Chung, 886-2-27953660 ext. 1303, peifangchung@actgenomics.com
About this study
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.
Read the 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.
- Conditions
- Sequence Analysis
- Being tested
- non intervention
- Keywords
- Genomic profiling assay
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non interventionOther
It is an non-interventional retrospective observational study by using archived paraffin-embedded tumor specimens
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (6)
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.
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
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
Measured: 12 months
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).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2018
- Study start26 Sep 2018
- Primary completionSep 2019 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sequence AnalysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ACT Genomics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Chi Mei Medical Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03719222
- Sponsor's protocol ID
- ACTG-18001
- Status last verified
- Oct 2018
- First submitted
- 15 Oct 2018
- Last updated
- 29 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Tumor Mutations and Tumor Microenvironment Using Archival Paraffin-embedded Tumor Specimens
- ClinicalTrials.gov ID
- NCT03719222
- Acronym / sponsor ID
- ACTG-18001
- Conditions
- Sequence Analysis
- Keywords
- Genomic profiling assay
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- ACT GenomicsIndustry (pharma, biotech, devices)
- Collaborators
- Chi Mei Medical Hospital
- Study start
- 26 Sep 2018 (actual)
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 25 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Sample from patients with histologically documented cancer in target population.
Key exclusion criteria (1 listed)
- Unusable sample or biologically deteriorated.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| non interventionIt is an non-interventional retrospective observational study by using archived paraffin-embedded tumor specimens | Other | – |
Primary outcome
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.
6 secondary outcomes
Single point mutations, as part of cancer genomic profile
Time frame: 12 months
Small insertions and deletions (Indel), as part of cancer genomic profile
Time frame: 12 months
Copy number alterations, as part of cancer genomic profile
Time frame: 12 months
Microsatellite instability, as part of genomic profile
Time frame: 12 months
TME gene expression profile, which consists of quantitative measurements of immune-related genes
Time frame: 12 months
Concordance of TMB between ACTOnco assay and an externally validated assay
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pei-Fang Chung contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sequence Analysis, run by ACT Genomics at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ACT Genomics ACT Genomics (+886-2-2795-3660, peifangchung@actgenomics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between TMB and the expression level of PD-1/PD-L1 (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2018.