LUCID: A Multicenter Case-Control Study of the Efficacy of EsoGuard on Samples Collected Using EsoCheck, versus EGD, for the Diagnosis of BE with and without Dysplasia, and for EAC
SPONSOR: Lucid Diagnostics
Primary Investigator: Gary Falk, MD
CONTACT NAME: Christine Gepty, BSN, RN | email: Christine.Gepty@pennmedicine.upenn.edu | phone: 215-349-8556
Criteria
Inclusion:
- Men aged 50 years and above
≥5 years either of:
- Gastroesophageal reflux disease symptoms
- GERD treated with PPI
- any combination of treated and untreated periods, as long the cumulative total is at least 5 years
AND
One or more of the following:
- Caucasian
- Current or past history of smoking
- BMI of at least 30 kg/m2
- First-degree relative with BE or EAC
Exclusion
Previous ablation, cryotherapy or endoscopic mucosal resection for the treatment.
- Patient reported dysphagia or pain with swallowing
- History of esophageal or gastric surgery
- History of esophageal or gastric surgery
SURVENT: A Multicenter Randomized Controlled Trial of Surveillance vs. Endoscopic Therapy for BE with LGD
Primary Investigator: Gary Falk, MD
CONTACT NAME: Christine Gepty, BSN, RN | email: Christine.Gepty@pennmedicine.upenn.edu | phone: 215-349-8556
Inclusion: Any patient with BE and LGD who meets all the following criteria will be eligible for enrollment:
- Subject has endoscopic evidence of BE of at least 1 cm in length
- Biopsies within the previous 12 months demonstrating BE and LGD
- Confirmation of LGD by expert central pathology panel from biopsies obtained within the previous 12 months (including those obtained from the referring physician)
- Demonstrated ability to tolerate PPI therapy based on patient self-report
Exclusion Criteria
- Prior EET for BE
- History of HGD or EAC
- Los Angeles Grade B or higher - patients are eligible upon resolution of erosive esophagitis