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NCT Number: NCT02100189

Esophageal Cytology With FISH in Detecting Esophageal Cancer

This clinical trial studies whether esophageal cytology plus fluorescence in situ hybridization (FISH) is equal to or better than esophago-gastro-duodenoscopy (EGD) or upper endoscopy for the early detection of esophageal cancer. Genes are the units of deoxyribonucleic acid (DNA) the chemical structure carrying genetic information that determine many human characteristics. Certain genes in cancer cells may determine how the tumor grows or spreads and how it may respond to different drugs. Part of this study is to test those genes in esophageal cells using FISH.

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Key information

Conditions

Dysphagia Adenocarcinoma Of Esophagus Body Weight Body Weight Changes Carcinoma Carcinoma, Squamous Cell Deglutition Disorders Digestive System Diseases Digestive System Neoplasms Dysplasia Esophageal Adenocarcinoma Esophageal Diseases Esophageal Motility Disorders Esophageal Neoplasms Esophageal Squamous Cell Carcinoma Esophagitis Gastroenteritis Gastroesophageal Reflux Gastroesophageal Reflux Disease Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms High Grade Dysplasia in Barrett Esophagus Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Pharyngeal Diseases Signs and Symptoms Weight Loss

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

About this study

PRIMARY OBJECTIVES:

I. Determine if sponge cytology with FISH is a reliable screening tool for esophageal dysplasia/cancer, and determine its sensitivity and specificity, compared to the gold standard procedure (upper endoscopy).

SECONDARY OBJECTIVES:

I. Determine if the cytology screening with FISH biomarkers is more cost effective than upper endoscopy for the screening of esophageal cancer and the surveillance of esophageal metaplasia and dysplasia.

II. Determine the limitations and future needs to improve this technique.

OUTLINE:

Participants swallow the capsule (Oesotest from Actimed) and then wait 10 minutes before the sponge is pulled out through the esophagus by gentle traction on the string. Cytology samples from the sponge are harvested and analyzed by FISH. Participants then undergo standard EGD or upper endoscopy.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects with known esophageal cancer diagnosed by previous endoscopy
  • Adenocarcinoma
  • Squamous cell carcinoma
  • Patients determined to be at risk for esophageal cancer:
  • Subjects with a history of Barrett's esophagus
  • Subjects with a history of low or high grade dysplasia
  • Subjects with a history of gastroesophageal reflux disease (GERD)
  • Subjects with a history of esophagitis
  • Subjects with symptoms of esophageal cancer (EC) referred for endoscopy (new onset dysphagia, weight loss, etc)
  • Patients must be scheduled for a procedure capable of providing a definitive pathological diagnosis and evaluating for complications of the esophageal sponge on the same day as the study procedure, either:
  • Upper endoscopy
  • Surgical esophagectomy
  • Subjects with Eastern Cooperative Oncology Group (ECOG) performance status =< 3 (Karnofsky >= 30%) will be included
  • Ability to understand and the willingness to sign a written informed consent document

Exclusion criteria

  • Subjects with severe, symptomatic dysphagia (unable to pass solids)
  • Subjects that are unable to swallow a tablet/pill for any reason
  • Subjects with a previous esophagectomy
  • Subjects with esophageal varices
  • Subjects unable to provide consent
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Treatment and study plan

Cytology Specimen Collection Procedure

Other

Undergo esophageal cytology collection

Other names: Cytologic Sampling

Esophagogastroduodenoscopy

Procedure

Undergo standard EGD or endoscopy

Other names: EGD

laboratory biomarker analysis

Other

Correlative studies

Primary outcomes

  1. Sensitivity of Sponge Cytology Using FISH

    Time frame: At the time of sponge cytology and EGD

    All processed (FISH) esophageal cells will be compared to the final pathologic esophageal diagnoses determined by EGD or surgical resection to assess the test's sensitivity and specificity for the diagnosis of esophageal cancer. Using EGD diagnostic outcomes as the gold standard, the sensitivity and specificity will be computed with corresponding 95% confidence interval of the FISH sponge cytology test in the study population.

  2. Specificity of Sponge Cytology Using FISH

    Time frame: At the time of sponge cytology and EGD

    All processed (FISH) esophageal cells will be compared to the final pathologic esophageal diagnoses determined by EGD or surgical resection to assess the test's sensitivity and specificity for the diagnosis of esophageal cancer. Using EGD diagnostic outcomes as the gold standard, the sensitivity and specificity will be computed with corresponding 95% confidence interval of the FISH sponge cytology test in the study population.

Secondary outcomes

  1. Adverse Events Associated With FISH Sponge Cytology Using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0

    Time frame: At the time of sponge cytology procedure

    Descriptive statistics will be used to summarize all adverse events associated with FISH sponge cytology test.

  2. Tolerability of FISH Spongy Cytology

    Time frame: After completion of FISH and EGD

    Tolerability is defined as the patient's willingness to repeat procedure.

Sponsors and collaborators

Lead sponsor

OHSU Knight Cancer Institute

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Esophageal Cancer (10030139, 10066354) Screening With FISH in Esophageal Cytology

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 31, 2014
Registry last updated
May 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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