Radiogenomics in Aerodigestive Tract Cancers

NCT04314349 | Completed DMC

• 1 other identifier: IRB108-249-A
• Study Type: observational
• Target: 139
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cancer, Lung; Cancer of Esophagus; Cancer of Head and Neck

Keywords

Aerodigestive tract cancers; Radiogenomics; F-18 FDG PET; Next generation sequencing

Outcome Measures

Primary Outcomes (1)

• Correlation of radiogenomics

  Study the correlation of radiomics and genomics and pathological features

  3 months

Secondary Outcomes (1)

• Treatment response and survival

  3 years

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Buddhist Tzu Chi General Hospital: lead

Study Sites (1)

Hualien Tzu Chi Hospital

Hualien City, 970, Taiwan

Location

MeSH Terms

Conditions

Lung Neoplasms; Esophageal Neoplasms; Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2020
• First Posted: March 19, 2020
• Study Start: August 1, 2020
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: March 22, 2024

Record last verified: 2022-09

Locations

TW (1)