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NCT03648879 · ClinicalTrials.gov registry record · Phase 2
Confocal Endoscopic Microscopy for Detection of Early Stage Gastric Cancer in Subjects With Hereditary Diffuse Gastric Cancer Syndrome
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 37
- Enrollment target
NCT03648879: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT03648879 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 37 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03648879, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 37 participants
- Enrollment target
Study Summary
Background: People with hereditary gastric cancer syndrome are at increased risk of getting cancer in their stomach. These people should have regular endoscopies and biopsies to check for cancer if they are choosing to keep their stomach. Researchers want to see if they can improve the detection of cancer by endoscopy. Improved endoscopies could better detect early signs of cancer in people with this syndrome. Objective: To see if a small microscope attached to an endoscope to inspect the stomach lining is better than regular endoscopy to find the first signs of cancer in the stomach. Eligibility: People ages 18 and older who have a personal or family history of a hereditary gastric cancer syndrome or have a mutation that is known to lead to gastric cancer Design: Participants will be screened over the phone or in person with: * Personal and family medical history * Review of their medical records Participants will have a physical exam. Then they will be put under general anesthesia. They will have an endoscopy. A lighted tube will be inserted into the mouth and go down to the stomach. First, the standard device will be used. Then participants will be injected with fluorescein. This is a contrast agent. Then the microscope will be added to the tube and the endoscopic evaluation of the stomach will be repeated. During the procedure, biopsies will be taken from different areas of the stomach. Participants will be observed for a few hours after the procedure. About 14 days after the endoscopy, participants will be asked to return to the clinic for a follow-up visit. This visit can also be conducted over the phone.
Interventions
- DEVICE Endoscope+Cellvizio(R) 100 microscope
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2019-02-11 |
| Est. Completion | 2020-05-05 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03648879
The ClinicalTrials.gov registry entry for NCT03648879 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 37 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Endoscope+Cellvizio(R) 100 microscope is the first listed.
NCT03648879 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03648879 about?
NCT03648879 is a clinical study titled "Confocal Endoscopic Microscopy for Detection of Early Stage Gastric Cancer in Subjects With Hereditary Diffuse Gastric Cancer Syndrome". Background: People with hereditary gastric cancer syndrome are at increased risk of getting cancer in their stomach. These people should have regular endoscopies and biopsies to check for cancer if they are choosing to keep their stomach. Researchers want to see if they can improve the detection of...
What is the current status of trial NCT03648879?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 37 participants. The study started on 2019-02-11. Estimated completion is 2020-05-05.
What interventions are being tested in trial NCT03648879?
The interventions under investigation include: Endoscope+Cellvizio(R) 100 microscope (DEVICE).
Who is sponsoring clinical trial NCT03648879?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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