Clinical trial · Interventional
Esophageal Cytology With FISH in Detecting Esophageal Cancer
Esophageal Cancer (10030139, 10066354) Screening With FISH in Esophageal Cytology
NCT02100189CI-TRIAL-00027516completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Dysphagia | — | UNRESOLVED | — |
| Dysplasia | — | UNRESOLVED | — |
| Esophageal Adenocarcinoma | Esophageal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Esophageal Squamous Cell Carcinoma | Esophageal Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Esophagitis | — | UNRESOLVED | — |
| Gastroesophageal Reflux Disease | — | UNRESOLVED | — |
| High Grade Dysplasia in Barrett Esophagus | — | UNRESOLVED | — |
| Weight Loss | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cytology Specimen Collection Procedure | Other | — | UNRESOLVED |
| Esophagogastroduodenoscopy | Procedure | — | UNRESOLVED |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Screening (esophageal cytology, FISH)
- description
- 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.
- interventionNames
- Other: Cytology Specimen Collection Procedure
- Procedure: Esophagogastroduodenoscopy
- Other: Laboratory Biomarker Analysis
Primary outcomes (2)
- measure
- Sensitivity of Sponge Cytology Using FISH
- timeFrame
- At the time of sponge cytology and EGD
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.