An observational study in Gene Mutation-Related Cancer, Esophageal Cancer and Radiation Exposure, sponsored by Fudan University. Status unknown at 1 site in China. Per ClinicalTrials.gov, last updated 2021-01-26.
Sponsored by Fudan University · Observational
Radiotherapy plays an important role in multidisciplinary treatment of esophageal cancer. However, about half patients received radiotherapy occurred relapse. Once relapse occurred, there is no better treatment strategy. Genomic study of relapsed esophageal cancer is seldom. So the investigators attempt to collect relapsed tissue to conduct with whole exome sequencing in order to investigate the genome landscape of recurrence esophageal cancer.
Tumor tissue of patients received radiotherapy with diagnosis of recurrence between Jan 1, 2010 and Dec 1, 2020 were collected retrospectively. Recurrence tumor tissue is collected between Dec 31, 2020 and Dec 31, 2022 prospectively. Blood and preradiotherapy tumor tissue were also collected to be as contrast. A total of 100 paired blood, preradiotherapy tumor tissue and relapse tumor tissue were collected. What is more, a total of 100 paired blood and preradiotherapy tumor tissue with diagnosis of no recurrence were collected. All samples were conducted with whole exome sequencing.
Here the investigators define recurrence period as within 2 years and no recurrence period as more than 3 years after radiotherapy.
Criteria of relapse: (1) pathologic diagnosis is squamous carcinoma before radiotherapy;(2) received radiotherapy; (3)pathologic diagnosis is also squamous carcinoma after radiotherapy; (4) clinical symptoms including feeding obstruction etc; (5) imaging evidence showed disease progression.
1,593 studies on the registry are indexed under Esophageal Neoplasms; 461 are open to participants now.
This study's planned enrollment of 200 is close to the median of 200 across 341 observational studies indexed under Esophageal Neoplasms.
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Recurrence group: 100 paired relapsed tumor tissue,blood and preradiotherapy tumor tissue within 2 years after radiotherapy were collected.
No recurrence group:100 paired blood and preradiotherapy tumor tissue with more than 3 years after radiotherapy were collected
Exclusion Criteria:
The period of recurrence was within 2 years after radiotherapy. Pathologic diagnosis was squamous cell carcinoma same with preradiotherapy.
Genetic: whole exome sequence
The period was more than 3 years after radiotherapy and no recurrence signs were observed.
Genetic: whole exome sequence
To seek genomic characteristics of relapsed esophageal cancer with whole exome sequence.
genomic characteristics of relapsed esophageal cancer
gene mutations, copy number variants
Time frame: through study completion, an average of 1 year
Plan to share: No
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This study is status unknown, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Fudan University