Digital Image Analysis and Fluorescent In Situ Hybridization in Predicting Development of Esophageal Cancer in Patients With Barrett Esophagus
Summary
RATIONALE: Diagnostic procedures, such as digital image analysis and fluorescent in situ hybridization, may help doctors learn the extent of Barrett esophagus.
PURPOSE: This randomized phase II trial is studying how well digital image analysis and fluorescent in situ hybridization predict development of esophageal cancer in patients with Barrett esophagus.
Description
OBJECTIVES:
- To determine whether fluorescent in situ hybridization (FISH) performed on cytology specimens correlates better than digital image analysis (DIA) with histology from surveillance biopsies in patients with Barrett esophagus.
- To determine whether the use of a high-capacity cytology collection device (i.e., a novel ultra-capacity cytology net or a high-capacity brush) affects the results of analysis with either FISH or DIA.
OUTLINE: Patients are stratified according to segment length of Barrett esophagus (BE) (≤ 3 cm vs > 3 cm). Patients are randomized to 1 of 3 arms.
- Arm I (high-capacity cytology brush): Patients undergo endoscopy to evaluate the BE for segment length, length and presence of islands or tongues of BE, and mucosal abnormalities. Patients then undergo mucus removal from the surface of the esophagus followed by brushings over the entire BE surface area using a high-capacity cytology brush. The BE is then biopsied and if mucosal abnormalities are elevated, the mucosa is resected.
- Arm II (low-capacity cytology brush): Patients undergo endoscopy and mucus removal as in arm I and brushings over the entire BE surface area using a low-capacity brush. Patients then undergo biopsy of the BE as in arm I.
- Arm III (cytology net): Patients undergo endoscopy and mucus removal as in arm I and brushings over the entire BE surface area using a cytology net. Patients then undergo biopsy of the BE as in arm I.
Collected cytology samples are examined by digital image analysis, including quantitative DNA staining, and fluorescent in situ hybridization to probe for c-myc 8q24.12-13, p16 (9p21), HER-2/neu (17q11.2-12), and 20q (20q13). Biopsy tissue samples are analyzed by histopathology. Cytology and biopsy tissue samples are also stored for future studies.
Study Design
Allocation: Randomized, Primary Purpose: Diagnostic
Conditions
Esophageal Cancer
Intervention
cytology specimen collection procedure, biopsy, diagnostic endoscopic procedure
Location
Mayo Clinic Cancer Center
Rochester
Minnesota
United States
55905
Status
Recruiting
Source
National Cancer Institute (NCI)
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00629109
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Cholangiopancreatography, Endoscopic Retrograde
Fiberoptic endoscopy designed for duodenal observation and cannulation of VATER'S AMPULLA, in order to visualize the pancreatic and biliary duct system by retrograde injection of contrast media. Endoscopic (Vater) papillotomy (SPHINCTEROTOMY, ENDOSCOPIC) may be performed during this procedure.
Sentinel Lymph Node Biopsy
A diagnostic procedure used to determine whether LYMPHATIC METASTASIS has occurred. The sentinel lymph node is the first lymph node to receive drainage from a neoplasm.
Norwood Procedures
A set of surgical procedures performed to establish sufficient outflow to the systemic circulation in individuals with univentricular congenital heart malformations, such as HYPOPLASTIC LEFT HEART SYNDROME, and MITRAL VALVE atresia, associated with systemic outflow obstruction. Follow-on surgeries may be performed and consist of a HEMI-FONTAN PROCEDURE as the stage 2 Norwood procedure and a FONTAN PROCEDURE as the stage 3 Norwood procedure.
Laparoscopy
A procedure in which a laparoscope (LAPAROSCOPES) is inserted through a small incision near the navel to examine the abdominal and pelvic organs in the PERITONEAL CAVITY. If appropriate, biopsy or surgery can be performed during laparoscopy.
Biliopancreatic Diversion
A surgical procedure which diverts pancreatobiliary secretions via the duodenum and the jejunum into the colon, the remaining small intestine being anastomosed to the stomach after antrectomy. The procedure produces less diarrhea than does jejunoileal bypass.
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