Using the Esophageal Adenocarcinoma and Barrett's Esophagus (EABE) Registry

Use these guidelines to write a request to use Mayo Clinic's EABE registry. Completed proposals should be sent to:

EABE Registry
Mary Fredericksen, CCRP
Mayo Clinic
Gonda 9 East-466
Deptartment of Gastroenterology & Hepatology
200 First Street SW
Rochester, MN 55905
USA

EABEC Registry Research Project Proposal Guidelines

Research Project Title:

Name of Requesting Investigator:
Institution:
Address:

Funding source:

Please send IRB minute item along with this form.
Other Collaborating Investigator(s) and their Institution(s):

Research Project Background or Rationale (two or three sentences):

Hypothesis:

Specific primary and secondary aims:

Methods:

  • Study design
  • Exact description of patient characteristics of interest (i.e., age range, gender, with/without hiatal hernia, with/without GERD symptoms, and further phenotype as described below)
    • Phenotype (1A): BASELINE phenotype
      • long segment Barrett's esophagus only
        • no dysplasia
        • low grade dysplasia
        • high grade dysplasia
      • esophageal adenocarcinoma only
      • esophageal squamous cell carcinoma only
      • combination Barrett's esophagus with adenocarcinoma
      • GE Junction adenocarcinoma only
      • GE Junction adenocarcinoma with background intestinal metaplasia of the cardia
      • mixed adeno/squamous cancer
    • Phenotype (1B): Cancer stage at diagnosis
      • Any stage
      • Stage 0 (Tis, N0, M0)
      • Stage I (T1, N0, M0)
      • Stage IIA (T2 or 3, N0, M0)
      • Stage IIB (T1 or 2, N1, M0)
      • Stage III (T3, N1, M0; OR T4, N0 or 1, M0)
      • Stage IVA (any T, any N, M1a)
      • Stage IVB (any T, any N, M1b)
    • Phenotype (2): CLINICAL OUTCOME phenotype — please be specific regarding time interval between phenotypes (e.g. 6 months? 1 year?)
      • Patients with long segment Barrett's esophagus who progressed from no dysplasia to low grade dysplasia
      • Patients with long segment Barrett's esophagus who progressed from no dysplasia to high grade dysplasia
      • Patients with long segment Barrett's esophagus who progressed from no dysplasia to any dysplasia
      • Patients with long segment Barrett's esophagus who progressed from no dysplasia to adenocarcinoma
      • Patients with long segment Barrett's esophagus who progressed from any dysplasia to adenocarcinoma
      • Long segment Barrett's esophagus patients who have not progressed beyond low grade dysplasia
      • Cancer patients still living
      • Cancer patients who have passed away
    • Phenotype (3): TREATMENT phenotype
      • Using a proton pump inhibitor at the time of specimen collection
      • Status post chemotherapy
      • Status post radiation therapy
      • Status post combination chemoradiation therapy
      • Status post esophagectomy
      • Status post photodynamic therapy
      • Status post BARRX treatment
      • Status post endoscopic mucosal resection

Specimen requested:

  • Tissue blocks
    • Type
  • Uninvolved small intestine
  • Uninvolved stomach
  • Uninvolved proximal squamous esophagus
  • Barrett's esophagus — any particular location(s) in the Barrett's segment?
  • Tumor — any particular part of the tumor?
    • Quantity
      • Number of slides
      • Thickness of each slide specimen
    • Preparation
      • Fresh frozen specimen
      • Formalin-fixed specimen
      • Special stain
  • Blood
    • Specimen type
      • Serum
      • Plasma
      • Buffy coat (wbc)
      • EBV-transformed lymphoblastoid cell lines
      • DNA
    • Quantity
      • Number of aliquots
      • Volume per aliquot of plasma/serum (200µl, 500µl, etc.)
      • Micrograms of DNA
      • Micrograms of mRNA
  • Questionnaire Forms
    • Family History/Adopted
    • Ethnicity/Race
    • Baseline and follow-up symptom surveys
    • Bronchoscopy
    • Chemotherapy
    • Clinical Staging —EUS
    • Endoscopy
    • Esophagectomy
    • Pathology
    • Quality of life
    • Radiology and Nuclear scanning
    • Relapse status post Therapy
    • Staging form after esophagectomy
  • Other
    • Urine collected
    • Stool collected
  • Proposed time frame for the study once samples received from the EABEC Registry

Statistical Considerations and Power Calculations:

Potential Funding Sources: [Attach copy of Research Project budget]

IRB approval date: [Attach copy of IRB approval minute item]

Anticipated scientific results:

How will use of EABEC Registry resources help you in regard to submission for a grant for funding and/or in achieving your professional/career goals?

Address to where you want the samples sent:

I agree to acknowledge the EABEC according to the guidelines in any research grant proposal or publication that is based upon use of these patient specimen and data.

Signature:
Date: