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NCT04314349Completed

Radiogenomics in Aerodigestive Tract Cancers

Source: ClinicalTrials.gov · Last updated 22 Mar 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
139 (actual)
First submitted
17 Mar 2020
Start date
1 Aug 2020
Primary completion date
31 Dec 2023
Lead sponsor
Buddhist Tzu Chi General Hospital
NCT number
NCT04314349

What you commit to

  • Study type: Observational
  • Participants enrolled: 139
  • From 1 Aug 2020 to the primary completion date, 31 Dec 2023
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Coexistence of non-aerodigestive tract cancer.

Other

  • Only receive best supportive care after diagnosis.
  • Unable to comply to FDG PET/CT exam.
  • Unable to determine the primary tumor.

Who the study is looking for

  • 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.

Age in the registry: 20 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hualien Tzu Chi Hospital
Coordinator of this site? Confirm its status
Hualien CityTaiwanUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.