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Clinical Trials/NCT03108885
NCT03108885
Terminated
Not Applicable

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

Mayo Clinic1 site in 1 country11 target enrollmentOctober 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Esophageal Neoplasm
Sponsor
Mayo Clinic
Enrollment
11
Locations
1
Primary Endpoint
Esophageal Cancer Mutation
Status
Terminated
Last Updated
2 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2017
End Date
May 25, 2020
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Exclusion Criteria

  • Age \<18 years old
  • Unable to provide consent

Outcomes

Primary Outcomes

Esophageal Cancer Mutation

Time Frame: 5 years

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.

Secondary Outcomes

  • Marker for Recurrence(5 years)

Study Sites (1)

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