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

NCT03108885 | Terminated

• 1 other identifier: 16-010506
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Marker for Recurrence

  5 years

Interventions

Blood and Tissue Collection OTHER

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.

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Undergoing surgery and follow up at Mayo Clinic Rochester for esophageal cancer.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Biospecimen

Retention: SAMPLES WITH DNA

Patients will have blood drawn prior to any neoadjuvant treatment or surgery. Tumor tissue will be collected and stored after pathologic evaluation has been completed. Blood collections will then be drawn at every subsequent follow up visit at Mayo Clinic for surveillance.

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Blood Specimen Collection; Tissue Banks

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Biological Specimen Banks; Health Facilities; Health Care Facilities Workforce and Services

Study Officials

• Shanda Blackmon, MD, MPH

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2017
• First Posted: April 11, 2017
• Study Start: October 1, 2017
• Primary Completion: May 25, 2020
• Study Completion: May 25, 2020
• Last Updated: March 22, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)