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

Terminated

• Conditions: Cancer of the Esophagus; Esophageal Cancer; Neoplasm, Esophageal; Esophageal Neoplasm; Cancer of Esophagus; Esophagus Cancer; Esophageal Neoplasms Malignancy Unspecified; Esophageal Neoplasms Malignant

• Registration Number: NCT03108885
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study First Submitted: 2017-04-06
• Study First Submitted QC: 2017-04-06
• Study First Posted: 2017-04-11
• Study Start: 2017-10-01
• Primary Completion: 2020-05-25
• Study Completion: 2020-05-25
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-21
• Last Update Posted: 2024-03-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Esophageal Cancer Mutation	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 Outcome Measures

Name	Time	Method
Marker for Recurrence	5 years	To validate cfDNA as a marker of recurrence of esophageal cancer.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States