DCLK1 as a Marker/Indicator of Stem Cell Response in Barrett's Esophagus/Esophageal Adenocarcinoma

Completed

Conditions studied: Barrett's Esophagus, Esophageal Adenocarcinoma

In brief

The hypotheses are: 1) the intestinal stem cell marker, DCLK1, which is increased in both the epithelium and stroma in colon cancer is also increased in BE (Barrett's esophagus) with HGD (high grade dysplasia) and in EAC (esophageal adenocarcinoma), 2) this expression correlates with disease progression towards EAC and 3) eradication of cells expressing stem cell markers occurs after therapy of EMR (endoscopic mucosal resection) or RFA (radiofrequency ablation) to eradicate BE with HGD and intramucosal adenocarcinoma and esophagectomy for EAC. We will test our hypotheses with the following aims: 1) To characterize the cell specific expression patterns of intestinal stem cell biomarkers in BE patients and correlate them with serum expression and disease progression, 2) To examine prospectively the effects of EMR, RFA or esophagectomy on the expression of stem cell biomarkers and the progression to EAC.

Key facts

Study ID

NCT03526328

Run by

University of Oklahoma

People needed

32

Starts

2013-03-01

Expected to finish

2019-08-13

Last updated by the study team

2020-03-06

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• BE length of 12 cm or less
• presence of non-dysplastic BE on 2 sequential endoscopies or low-grade intraepithelial dysplasia (LGIN), high-grade intraepithelial dysplasia (HGIN) or EAC in BE segment on 2 endoscopies in the previous 6 months
• no signs of metastasis on endoscopic ultrasonography or computerized tomography scan.

You may not qualify if…

• pre-RFA EMR with cancer at the resection margin
• greater than T1sm1 invasion
• poor differentiation or worse
• angiolymphatic invasion
• esophageal stenosis preventing passage of an 11.3 mm endoscope
• persistent visible lesions after EMR before RFA and invasive cancer on biopsies after EMR pre-RFA.

Where it is running

• Gastroenterology — Oklahoma City, Oklahoma, United States

Full record on ClinicalTrials.gov

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