Detecting early esophageal cancer using sponge cytology
EsophaCap for the Detection of Early Esophageal Carcinoma
This study is testing if a sponge can help find early signs of esophageal cancer and Barrett's Esophagus in people having an endoscopy at Johns Hopkins Hospital.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Johns Hopkins University Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Baltimore, Maryland and 1 other locations) |
| Trial ID | NCT04214119 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify potential biomarkers for the early detection of Barrett's Esophagus, esophageal carcinoma, and gastric cancer through the use of sponge cytology. Participants undergoing esophagogastroduodenoscopy at Johns Hopkins Hospital will have cytology samples collected via a sponge capsule. The study will analyze DNA from these samples to identify optimal biomarkers that can differentiate between Barrett's esophagus and cancerous conditions versus normal tissue. The goal is to enhance early detection methods for these serious conditions.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 who are scheduled for esophagogastroduodenoscopy at Johns Hopkins Hospital.
Not a fit: Patients with extra-esophageal malignancies, those who have undergone esophagectomy, or have conditions that prevent capsule swallowing will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier and more accurate detection of esophageal and gastric cancers, improving patient outcomes.
How similar studies have performed: Other studies have shown promise in using cytology for cancer detection, but this specific approach with sponge cytology is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Undergoing esophagogastroduodenoscopy at Johns Hopkins Hospital from 1/2016 to 12/2025 * Age greater than 18 years * Patients must be able to swallow a capsule Exclusion Criteria: * Patients in either arm with extra-esophageal malignancies including head and neck and gastric cancer * Patients who have undergone esophagectomy * Patients who have undergone radiation to the chest * Patients who are younger than 18 * Patients with esophageal stents * Patients with esophageal strictures disabling passage of the capsule
Where this trial is running
Baltimore, Maryland and 1 other locations
- Bayview Medical Center — Baltimore, Maryland, United States (Recruiting)
- Johns Hopkins Hospital — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Stephen Meltzer, M.D. — Johns Hopkins University
- Study coordinator: Stephen J Meltzer, M.D.
- Email: smeltzer@jhmi.edu
- Phone: 4105026071
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.