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NCT03108885 Clinical Trial

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

Esophageal Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT03108885
Other study ID # 16-010506
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date October 1, 2017
Est. completion date May 25, 2020

Study information
Verified date March 2024
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Terminated
Enrollment 11
Est. completion date May 25, 2020
Est. primary completion date May 25, 2020
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• 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.

Locations
Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Esophageal Cancer Mutation 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. 5 years
Secondary Marker for Recurrence To validate cfDNA as a marker of recurrence of esophageal cancer. 5 years
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