Measuring Cell Free DNA During the Course of Treatment for Esophageal Cancer as a Marker of Response and Recurrence

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

11 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-01

Study Completion Date

2020-05-25

Brief Summary

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To prospectively collect blood and tumor tissue from esophageal cancer patients to identify specific esophageal cancer mutations that can be measured in the blood (cell free DNA) during the course of treatment as a marker of response and recurrence.

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Detailed Description

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Esophageal carcinoma is an aggressive malignancy and about a third of patients present with distant metastatic disease. While survival is slowly improving with better diagnostic tools and therapy, the overall 5-year survival remains low at 18%. Unlike other malignancies, such as colon cancer and prostate cancer, there is no peripheral blood marker of response or recurrence during treatment in esophageal cancer. However, quantifying cfDNA is a unique and tumor specific avenue that may allow real time response to treatment in esophageal cancer.

To identify esophageal cancer specific mutations, tumor samples will undergo whole exome sequencing. From this data, the investigators will select 10-15 genes to focus their efforts. PCR primers will be designed to detect these tumor specific mutations in the cell-free component of peripheral blood samples over the course of treatment for esophageal cancer.

The investigators will obtain baseline blood (before treatment) and then collect blood after neoadjuvant treatment, after surgery, and then at subsequent visits from the participants.

Conditions

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Esophageal Neoplasm Esophageal Neoplasms Malignancy Unspecified Esophageal Neoplasms Malignant Cancer of Esophagus Cancer of the Esophagus Esophageal Cancer Esophagus Cancer Neoplasm, Esophageal

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Blood and Tissue Collection

Blood DNA will be isolated from plasma. Tumor DNA will be purified with a kit and amplified regions of 10 genes discovered to by mutated in whole exome sequencing.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Esophageal Cancer any stage
* Age \>18 years old
* Willing and able to provide consent
* No prior history of neoadjuvant therapy for the esophageal cancer