NCT03222635 Prospective Endoscopic Follow-up of Patients With Submucosal and High Risk Mucosal Esophageal Adenocarcinoma
| NCT ID | NCT03222635 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Amsterdam UMC |
| Condition | Submucosal Esophageal Adenocarcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 225 participants |
| Start Date | 2017-07-25 |
| Primary Completion | 2028-07-25 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 225 participants in total. It began in 2017-07-25 with a primary completion date of 2028-07-25.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Aim of this prospective multicenter study is to evaluate the safety of an endoscopic follow-up strategy in patients treated with endoscopic resection (ER) for submucosal or high-risk mucosal esophageal adenocarcinoma (T1bN0M0 or HR T1aN0M0 EAC).
Eligibility Criteria
Inclusion Criteria: * Patients with submucosal or high-risk mucosal EAC diagnosed in an ER specimen, by an expert gastrointestinal (GI) pathologists. * Signed informed consent. Exclusion Criteria: * Prior history of high-risk mucosal or ≥T1sm. * Synchronous esophageal squamous cell carcinoma. * Suspicion on lymph node metastasis or distant metastasis on EUS, ultrasound of the neck or CT-thorax-abdomen performed six weeks after ER during baseline measurement. * Tumor-positive deep resection margin (R1) in ER specimen. * Patients unable to give signed informed consent.
Contact & Investigator
J. J. Bergman, MD, PhD
PRINCIPAL INVESTIGATOR
Amsterdam UMC
Frequently Asked Questions
Who can join the NCT03222635 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Submucosal Esophageal Adenocarcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03222635 currently recruiting?
Yes, NCT03222635 is actively recruiting participants. Contact the research team at v.bos@amsterdamumc.nl for enrollment information.
Where is the NCT03222635 trial being conducted?
This trial is being conducted at Sydney, Australia, Brussels, Belgium, Ghent, Belgium, Leuven, Belgium and 11 additional locations.
Who is sponsoring the NCT03222635 clinical trial?
NCT03222635 is sponsored by Amsterdam UMC. The principal investigator is J. J. Bergman, MD, PhD at Amsterdam UMC. The trial plans to enroll 225 participants.