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AzTrials

Cancer, LungNCT04314349

Radiogenomics in Aerodigestive Tract Cancers

An observational study of Cancer, Lung and Cancer of Esophagus, run by Buddhist Tzu Chi General Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Aerodigestive tract cancers are common malignancies. These cancers were ranked to be top-ten cancer-related deaths in Taiwan. Although many new target therapies and immunotherapies have emerged, many of the treatment eventually fail. Read more about this study

Who is it for?
Ages 20 years and older
How many people
139 participants
Where
1 siteTaiwan
Study dates
1 Aug 2020to 31 Dec 2023
How long will I take part?
3 Years
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 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with aerodigestive tract cancer only, and able to be analyzed with radiomics of FDG PET.

Who may be able to join

  • Age at least 20-years
  • Pathological proven aerodigestive tract cancers and received complete staging work-up
  • Pathological specimen of the primary tumor
  • The solid part of the primary tumor should be at least 2 cm for the lung or head and neck cancers. The primary tumor of the esophageal cancer should be at least cT2.

Who cannot join

  • Coexistence of non-aerodigestive tract cancer.
  • Only receive best supportive care after diagnosis.
  • Unable to comply to FDG PET/CT exam.
  • Unable to determine the primary tumor.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site
  • Hualien Tzu Chi Hospital

    Hualien City, 970

Other trials in Taiwan

About this study

Aerodigestive tract cancers are common malignancies. These cancers were ranked to be top-ten cancer-related deaths in Taiwan. Although many new target therapies and immunotherapies have emerged, many of the treatment eventually fail. For example, a 30-40% failure rate has been reported for target therapy, and, even higher for immune checkpoint inhibitors. A reliable model to more accurately predict treatment response and survival is warranted. The radiomic features extracted from F-18 fluorodeoxyglucose (18F-FDG) positron emission tomography (PET) can be used to figure tumor biology such as metabolome and heterogeneity. It can therefore be used to predict treatment response and individual survival. On the other hand, genomic data derived from next-generation sequencing (NGS) can interrogate the genetic alteration of cancer cells. It can be used to feature genetic identification of the tumor and can also be used to identify target genes. However, both modalities have their weakness; a combination of the two may devise a more powerful predictive model for more precise clinical decision. The investigators plan to recruit patients aged at least 20-year with the diagnosis of aerodigestive tract cancers for radiogenomic study. Our previous studies have found that radiomic features derived from 18F-FDG PET can predict treatment response and survival in patients with esophageal cancer treated with tri-modality method. The investigators also discovered that radiomics could predict survival in patients with EGFR-mutated lung adenocarcinoma treated with target therapy. In addition, our study results showed that the level of PD-L1 expression is associated with radiomics as well. The investigators plan to add genomic data into radiomics and interrogate cancers from different aspects. The investigators seek to devise a more precise model to predict the treatment response and survival in patients with aerodigestive tract cancers.

Read the detailed description

This is a prospective study and The investigators use the routine pathological specimens for next generation sequencing (NGS), microsatellite instability (MSI) and immunohistochemical stains.

Pathological examinations including PD-L1, EGFR status, ALK and ROS-1.

NGS (Next Generation Sequencing): Total DNA were extracted from EDTA-peripheral venous blood and paraffin-embedded tumor specimens with the QIAamp® DNA Blood Mini Kit and QIAamp DNA FFPE Tissue Kit (QIAGEN GmbH, Hilden, Germany), respectively. For DNA whole exome sequence, briefly, tumor and blood DNA were sonicated by Covaris M220 sonicator (Life Technologies Europe, Gent, Belgium) and then ligated to adaptor for further amplification (Illumina® TruSeq Exome Library Prep, USA). All of library preparation were performed in the Cancer Translational Core Facility of Taipei Medical University. After library preparation, all samples were sequenced using the NextSeq500 system according to the manufacturer's instructions (Illumina, San Diego, USA). After sequencing performance, quality of reads file (fastq) was assessed by FastQC and then mapped using human Hg19 as the reference. Bam files were used as input for the Varscan algorithm to identify germline and somatic mutations. Variants annotated and filtered were manually checked using IGV (Integrative Genomics Viewer), then confirmed by Sanger sequence.

To calculate the TMB (total mutation burden) per megabase, the total number of mutations counted is divided by the size of the coding region of the targeted territory.

To calculate MATH (mutant-allele tumor heterogeneity), The investigators will first obtain the MAF (the fraction of DNA that shows the mutated allele at a gene locus) of each tumor specimen. The MAF distribution will be used to calculate the median (center of distribution) and the MD (median deviation) of MAFs in a tumor. The MD is determined by obtaining the absolute differences of all MAFs from the median MAF. Then the median of the absolute differences is multiplied by a factor of 1.4826 to obtain the MD. The MATH value is calculated as the percentage ratio of the MD to the median: MATH = (MD/median)×100.

MSI (Microsatellite instability) Microsatellite instability polymerase chain reaction (MSI-PCR) MSI-PCR testing was performed by the Cancer Translational Core Facility of Taipei Medical University using Promega MSI analysis kit (Promega). The MSI analysis consists of five nearly monomorphic mononucleotide markers (BAT-25, BAT-26, NR- 21, NR-24, and MONO-27) for MSI determination. MSI analysis was performed according to the manufacturer's directions (Promega). Products were analyzed by capillary electrophoresis and the investigators interpreted microsatellite instability at 2 or more of the 5 mononucleotide loci as MSI-high, microsatellite instability at a single mononucleotide locus as MSI-low, and no instability at any of the loci as microsatellite stable (MSS).

The image features of FDG PET the investigators extracted as followed:

The traditional image parameters include SUVmax, metabolic tumor volume (MTV) and total lesion glycolysis (TLG) of the primary tumor. The traditional FDG PET parameters were calculated using commercialized software (PBAS, PMOD 4.0). Radiomics (texture analysis) will be calculated only for pre-treatment FDG PET. The matrices of radiomic analysis include histogram analysis, Gray-level co-occurrence matrix (GLCM)、texture feature coding co-occurrence matrix (TFCCM)、gray-level run-length matrix (GLRLM)、gray-level size zone matrix (GLSZM)、neighborhood gray-tone difference matrix (NGTDM)、Texture Feature Coding Matrix (TFCM)、Texture Feature Coding Co-Occurrence Matrix (TFCCM) and Neighbouring Gray Level Dependence Matrix (NGLD).

Keywords
Aerodigestive tract cancers, Radiogenomics, F-18 FDG PET, Next generation sequencing
Medical subject headings
Lung Neoplasms, Esophageal Neoplasms, Head and Neck Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Correlation of radiogenomics

    Study the correlation of radiomics and genomics and pathological features

    Measured: 3 months

Secondary outcomes (1)
  1. Treatment response and survival

    Study the association of radiogenomics with the treatment response and survival

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Mar 2020
  2. Study start1 Aug 2020
  3. Primary completion31 Dec 2023
  4. Study completion31 Dec 2023

Resources

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
Prospective
Enrolment
139 participants (actual)
Target duration
3 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT04314349
Sponsor's protocol ID
IRB108-249-A
Status last verified
Sep 2022
First submitted
17 Mar 2020
Last updated
22 Mar 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Cancer, Lung and Cancer of Esophagus, run by Buddhist Tzu Chi General Hospital 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 22 Mar 2024. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Correlation of radiogenomics (time frame: 3 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 22 Mar 2024.

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