Esophageal Cancer Risk Registry

StatusRecruiting
PhaseNot specified
Started

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Record History

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  1. Site contact updatedv24
  2. Site contact updatedv23
  3. Site contact updatedv22
  4. Site contact updatedv21
  5. Site contact updatedv20
Show 18 earlier versionsHide 18 earlier versions
  1. Enrollment target: 6000 to 7000
    • Interventions: Biopsies from routine clinical surveillance endoscopies (Procedure), Biopsy of esophageal/stomach tissue, lymph nodes, tumor (Procedure)… to Biopsies, oral (saliva) and/or secretions, washings or mucosal scrapings/brushing from routine clinical surveillance endoscopies…
    • Study description expanded, about 49 words
    • Site contact updated
    v19
  2. Site contact updatedv18
  3. Site contact updatedv17
  4. Site contact updated
    • Study description expanded, about 5 words
    v16
  5. Enrollment target: 4500 to 6000
    • Site contact updated
    • Collaborators: 1 to 2
    • Eligibility criteria expanded, about 1 word
    v15
  6. Site contact updatedv14
  7. Site contact updatedv13
  8. Enrollment target: 3000 to 4500v12
  9. Primary and study completion dates: Dec 2050
    • Site contact updated
    v11
  10. Study site revisedv10
  11. 2 versions Re-verified since Oct 13, 2008, no change to tracked fieldsv8-v9
  12. Enrollment target: 1500 to 3000v7
  13. 3 versions Re-verified since Jul 25, 2006, no change to tracked fieldsv4-v6
  14. Interventions: Biopsies from routine clinical surveillance endoscopies. (Procedure), Biopsy of esophageal/stomach tissue,lymph nodes,tumor. (Procedure)… to Biopsies from routine clinical surveillance endoscopies (Procedure), Biopsy of esophageal/stomach tissue, lymph nodes, tumor (Procedure)…
    • Eligibility criteria expanded, about 7 words
    • Study description expanded, about 2 words
    v3
  15. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The purpose of this study is to identify markers in the blood and tissue that could indicate risk factors for the development and progression of esophagus cancer. This research aims to collect medical history, blood, and tissue samples from patients who present with an esophageal disorder. Identifying genetic and behavioral risk factors involved in the development of esophageal cancer might allow for early detection and prevention. Survival and an opportunity for a cure with esophageal cancer will depend greatly on the stage of diagnosis. Tumors can develop changes in their genetic (hereditary) make-up, and these changes can sometimes be seen in normal tissues before the development of cancer. These genetic (hereditary) changes can serve as tumor markers and can be detected using methods that study changes in genetic material like DNA and RNA. The analysis of proteins can provide additional information. By identifying changes in these molecules that are different or altered in cancer, the investigators can use methods and tests for the detection of these changes.
Trial Details
NCT Number NCT00260585
Lead Sponsor University of Pittsburgh
Collaborators: National Institutes of Health (NIH), National Cancer Institute (NCI)
Conditions
(from sponsor)		 Esophageal Cancer, Gastroesophageal Reflux Disease (GERD), Esophageal Diseases, Hiatal Hernia, Esophageal Achalasia
Related terms Esophageal Achalasia, Esophageal Diseases, Esophageal Neoplasms, Gastroesophageal Reflux, Hernia, Hiatal
Enrollment 7,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov