Dysphagia, Dysplasia, Esophageal Adenocarcinoma, Esophageal Squamous Cell Carcinoma, Esophagitis, Gastroesophageal Reflux Disease, High Grade Dysplasia in Barrett Esophagus, Weight Loss
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERCytology Specimen Collection Procedure
Undergo esophageal cytology collection
PROCEDUREEsophagogastroduodenoscopy
Undergo standard EGD or endoscopy
OTHERLaboratory Biomarker Analysis
Correlative studies
Sponsors
National Cancer Institute (NCI)
OHSU Knight Cancer Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of Sponge Cytology Using FISH | 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. |
| Specificity of Sponge Cytology Using FISH | 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
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events Associated With FISH Sponge Cytology Using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 | At the time of sponge cytology procedure | Descriptive statistics will be used to summarize all adverse events associated with FISH sponge cytology test. |
| Tolerability of FISH Spongy Cytology | After completion of FISH and EGD | Tolerability is defined as the patient's willingness to repeat procedure. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Esophageal Cell Harvesting Procedure 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. | 50 |
| Total | 50 |
Baseline characteristics
| Characteristic | Esophageal Cell Harvesting Procedure |
|---|---|
| Age, Continuous | 64 years STANDARD_DEVIATION 13.4 |
| Body Mass Index, average | 29.5 kg/m^2 STANDARD_DEVIATION 7.66 |
| Number of participants with a history of PPI use | 39 Participants |
| Number of participants with history of Barrett's Esophagus | 28 Participants |
| Number of participants with history of GERD | 38 Participants |
| Region of Enrollment United States | 50 participants |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 16 / 50 |
| serious Total, serious adverse events | 0 / 50 |
Outcome results
Primary
Sensitivity of Sponge Cytology Using FISH
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.
Time frame: At the time of sponge cytology and EGD
Population: Analysis was per protocol
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Esophageal Cell Harvesting Procedure | Sensitivity of Sponge Cytology Using FISH | 13.3 percentage of cases among positive tests |
95% CI: [3.76, 30.72]Sensitivity
Primary
Specificity of Sponge Cytology Using FISH
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.
Time frame: At the time of sponge cytology and EGD
Population: Per protocol
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Esophageal Cell Harvesting Procedure | Specificity of Sponge Cytology Using FISH | 94.7 Percentage of non-cases among neg tests |
95% CI: [73.97, 99.87]Specificity
Secondary
Adverse Events Associated With FISH Sponge Cytology Using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Descriptive statistics will be used to summarize all adverse events associated with FISH sponge cytology test.
Time frame: At the time of sponge cytology procedure
Population: Intent to Treat (ITT)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Esophageal Cell Harvesting Procedure | Adverse Events Associated With FISH Sponge Cytology Using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 | 16 adverse events |
Secondary
Tolerability of FISH Spongy Cytology
Tolerability is defined as the patient's willingness to repeat procedure.
Time frame: After completion of FISH and EGD
Population: Intent to Treat (ITT)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Esophageal Cell Harvesting Procedure | Tolerability of FISH Spongy Cytology | 100 percentage of subjects tolerating test |