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Racial Disparity in Barrett's Esophagus

21. September 2015 aktualisiert von: Nicholas Shaheen, MD, University of North Carolina, Chapel Hill

The goal of the proposed research is to investigate the molecular mechanisms of racial disparity in Barrett's esophagus (BE), the premalignant lesion of esophageal adenocarcinoma. Specifically, the investigators hypothesize that environmental factors, genetic factors, and potentially gene environment interactions play crucial roles in the observed racial disparity in developing Barrett's esophagus.

Patients are recruited through UNC hospitals prior to scheduled esophagogastroduodenoscopy (EGD). Participants complete a questionnaire, have body measurements obtained, and have blood, biopsies, and gastric aspirate collected. Participants also complete a 24 hour pH impedance test.

Studienübersicht

Detaillierte Beschreibung

The goal of the proposed research is to investigate the molecular mechanisms of racial disparity in Barrett's esophagus, the premalignant lesion of esophageal adenocarcinoma. Specifically, the investigators hypothesize that environmental factors, genetic factors, and potentially gene environment interactions play crucial roles in the observed racial disparity in developing Barrett's esophagus.

Participants: Patients aged 18-80 presenting at the Gastrointestinal (Gl) Endoscopy Clinic at UNC-Chapel Hill for elective upper endoscopy with a primary or secondary indication of reflux symptoms.

Procedures (methods): Endoscopic biopsy, pH impedance and sampling of gastric secretions will be performed according to our standard protocol. A series of questionnaires assessing demographics, environmental exposure (e.g., smoking, drinking), markers of socioeconomic status (SES), body measurement, previous health history, and gastroesophageal reflux disease (GERD) symptomatology will be administered to our subjects.

Studientyp

Beobachtungs

Einschreibung (Tatsächlich)

255

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

    • North Carolina
      • Chapel Hill, North Carolina, Vereinigte Staaten, 27599
        • University of North Carolina Chapel Hill

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 80 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

The source of the study population will be patients aged 18-80 presenting at the gastrointestinal (Gl) Endoscopy Clinic at UNC-Chapel Hill for elective upper endoscopy with a primary or secondary indication of reflux symptoms. Any patient undergoing endoscopy with classic reflux symptoms is eligible to participate in the study. These symptoms include a substernal chest burning or warmth, a "waterbrash" sensation, regurgitation, or any chest pain worst when supine or after meals.

Race will be self-identified race or ethnicity (SIRE) from a researcher-provided list. According to the NIH Policy on Reporting Race and Ethnicity Data published in August 8, 2001 (NOT-OD-01-053), we will "use two separate questions with ethnicity information collected first followed by the option to select more than one racial designation." Patients in this study should be "Not Hispanic or Latino", and either "African American" or "White".

Beschreibung

Inclusion Criteria:

  • Aged 18 to 80
  • Self-identify is "not Hispanic or Latino" and either "African American" or "White."
  • Cases will be eligible for inclusion if they have endoscopically evident Barrett's Esophagus (BE) of any length. BE will be defined as: 1) Any upward displacement of the squamocolumnar junction noted on endoscopy such that the interface of squamous and columnar mucosa is no longer at the interface of the most distal tubular esophagus and the proximal gastric folds. The characteristic pale pink coloration of the squamous epithelium in these areas will be replaced by the darker salmon color commonly seen in BE. 2) Histologic interpretation of biopsies consistent with intestinal columnar metaplasia containing goblet cells, which are positively stained by Alcian blue staining as barrel-shaped cells.
  • Controls will be eligible for inclusion if they have classic symptoms of gastroesophageal reflux disease (GERD), but no endoscopic or histological evidence of BE. Both erosive and non-erosive GERD will be eligible. Because we expect GERD to outnumber BE and patients with GERD may be slightly less willing to participate in the study than patients with BE (based on recruitment for the studies noted above), we plan to randomly sample one fourth of eligible controls. If approximately 20% fewer GERD than BE participate, a final study population with an approximately 1:2 BE to GERD ratio will be achieved. Oversampling of patients with GERD will improve study power.

Exclusion Criteria:

  • Patients who are unable to read or comprehend the informed consent or written questionnaires;
  • Patients who are status post partial or complete esophageal resection;
  • Patients with prevalent BE who have undergone endoscopic ablation;
  • Patients found to have high-grade dysplasia or esophageal cancer on the index endoscopy;
  • Patients with surgical anti-reflux procedures;
  • Patients of races other than Caucasian and African Americans;
  • Pregnant women.
  • Patients with a bleeding diathesis or other contraindication of endoscopic biopsy.
  • Current use of warfarin, heparin, and/or low molecular weight heparin (requires discontinuation of medication 5 days prior to and 7 days after EGD).

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
White GERD
Participants who self-identify as "not-Hispanic or Latino" and "White" and have been diagnosed by a physician with gastroesophageal reflux disease and do not have Barrett's esophagus.
African American GERD
Participants who self-identify as "not-Hispanic or Latino" and "African American" and have been diagnosed by a physician with gastroesophageal reflux disease and do no have Barrett's esophagus.
White BE
Participants who self-identify as "not-Hispanic or Latino" and "White" and have been diagnosed by a physician with Barrett's Esophagus.
African American BE
Participants who self-identify as "not-Hispanic or Latino" and "African American" and have been diagnosed by a physician with Barrett's Esophagus.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
To examine the association between BE and environmental factors
Zeitfenster: Enrollment (day 1)
Odds ratios (ORs) and 95% confidence intervals (CI) will be used to estimate the association between gastroesophageal reflux disease (GERD) and Barrett's esophagus (BE) among Caucasian Americans and African Americans, separately, in relation to patterns of the exposures of interest (tobacco use, alcohol consumption, fruit and vegetable intake and other dietary measures, no NSAID use, and various measures of SES), with adjustments made for the frequency matching factors, age at reference (date of diagnosis for cases and date of identification for controls) and sex.
Enrollment (day 1)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
To investigate the association between BE and genetic and epigenetic status of Cdx1/Cdx2
Zeitfenster: Enrollment (day 1)
The promoter regions of Cdxl and Cdx2 genes will be examined for single nucleotide polymorphisms (SNPs). Pyrosequencing will be used to quantitatively determine the methylation status of Cdxl and Cdx2 promoters in esophageal biopsy tissues. For the single functional genotype analyses, conventional unconditional logistic regression will be used and ORs will be estimated for "at-risk" homozygotes and heterozygotes relative to "wild-type" homozygotes by creating indicator variables for each genotype.
Enrollment (day 1)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

  • Hauptermittler: Nicholas Shaheen, MD, MPH, University of North Carolina, Chapel Hill
  • Hauptermittler: Xiaoxin Chen, MD, PhD, North Carolina Central University

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. März 2011

Primärer Abschluss (Tatsächlich)

1. Januar 2014

Studienabschluss (Tatsächlich)

1. Januar 2014

Studienanmeldedaten

Zuerst eingereicht

9. Juni 2011

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

14. Juni 2011

Zuerst gepostet (Schätzen)

15. Juni 2011

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

23. September 2015

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

21. September 2015

Zuletzt verifiziert

1. September 2015

Mehr Informationen

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