Barrett's Esophagus Clinical Trial
Official title:
Doublecortin Like Kinase-1 as a Marker and Indicator of Treatment Response for Intestinal Stem Cells in Barrett's Esophagus and Progression to Esophageal Adenocarcinoma
NCT number | NCT03526328 |
Other study ID # | 1885 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 2013 |
Est. completion date | August 13, 2019 |
Verified date | March 2020 |
Source | University of Oklahoma |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 32 |
Est. completion date | August 13, 2019 |
Est. primary completion date | August 13, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United States | Gastroenterology | Oklahoma City | Oklahoma |
Lead Sponsor | Collaborator |
---|---|
University of Oklahoma |
United States,
Vega KJ, May R, Sureban SM, Lightfoot SA, Qu D, Reed A, Weygant N, Ramanujam R, Souza R, Madhoun M, Whorton J, Anant S, Meltzer SJ, Houchen CW. Identification of the putative intestinal stem cell marker doublecortin and CaM kinase-like-1 in Barrett's esophagus and esophageal adenocarcinoma. J Gastroenterol Hepatol. 2012 Apr;27(4):773-80. doi: 10.1111/j.1440-1746.2011.06928.x. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | cell-specific expression patterns of putative intestinal stem cell biomarkers in BE patients; correlation of markers with serum/plasma protein expression and disease progression. | Exploratory; analysis of expression of various markers for Barrett's esophagus and esophogeal adenocarcinoma | 2 yrs |
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