Biomarkers and Functional Imaging in Predicting Response of Esophageal Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03029793|
Recruitment Status : Recruiting
First Posted : January 24, 2017
Last Update Posted : January 24, 2017
|Condition or disease||Intervention/treatment|
|Esophageal Cancer||Other: Biomarkers Testing Other: Functional Imaging analysis|
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Combination of Molecular Biomarkers and Functional Imaging in Predicting Pathologic Response and Clinical Outcomes in Squamous Esophageal Cancer Patients Who Undergo Trimodality Therapy|
|Study Start Date :||May 2016|
|Estimated Primary Completion Date :||January 2019|
|Estimated Study Completion Date :||January 2020|
Biomarkers and Imaging analysis
This study will prospectively collect the tissue and blood samples of locally advanced esophageal cancer patients, perform CRT resistance biomarkers testing and functional imaging analysis including SUV value and texture parameters of 18F-FDG PET-CT as well as ADC values DWI-MRI before treatment, 2-3 weeks after the initiation of CRT, and 4 weeks post-nCRT. The investigators will use advanced statistical tools to establish the model and further validate the model in another group of patients. The investigators will also establish a model for survival prediction.
Other: Biomarkers Testing
CRT resistance biomarkers will be detected before CRT, 2-3 weeks after the initiation of CRT, and 4 weeks post-CRT.
Other: Functional Imaging analysis
The SUV value and texture parameters of 18F-FDG PET-CT as well as ADC values DWI-MRI will be measures before CRT, 2-3 weeks after the initiation of CRT, and 4 weeks post-CRT.
- Pathologic Response [ Time Frame: Approximately 12 months ]Mandard tumor regression grade (TRG) was used for pathology analysis. Primary tumor and positive lymph node regression were classified into five histologic tumor regression grades. Grade 1 (complete regression) showed absence of histologically identifiable residual cancer and fibrosis extending through the different layers of the esophageal wall, with or without granuloma. Grade 2 was characterized by the presence of rare residual cancer cells scattered through the fibrosis. Grade 3 involved an increase in the number of residual cancer cells, but fibrosis still predominated. Grade 4 showed residual cancer outgrowing fibrosis. Grade 5 was characterized by the absence of regressive changes.
- Overall Survival [ Time Frame: Approximately 4 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03029793
|Contact: Li-Na Zhao, MD, Ph.Demail@example.com|
|Department of Radiation Oncology, Xijing Hospital, Fourth Military Medical University||Recruiting|
|Xi'an, Shaanxi, China, 710032|
|Contact: Lina Zhao, MD, Ph.D +86-029-84775425 firstname.lastname@example.org|
|Principal Investigator: Lina Zhao, Ph.D|
|Principal Investigator: Mei Shi, MD|
|Study Chair:||Mei Shi, MD||Department of Radiation Oncology, Xijing Hospital, Fourth Military Medical University|