Confocal Endoscopic Microscopy for Detection of Early Stage Gastric Cancer in Subjects With Hereditary Diffuse Gastric Cancer Syndrome
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ClinicalTrials.gov Identifier: NCT03648879 |
Recruitment Status :
Completed
First Posted : August 28, 2018
Last Update Posted : September 3, 2020
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Tracking Information | |||||
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First Submitted Date ICMJE | August 24, 2018 | ||||
First Posted Date ICMJE | August 28, 2018 | ||||
Last Update Posted Date | September 3, 2020 | ||||
Actual Study Start Date ICMJE | February 11, 2019 | ||||
Actual Primary Completion Date | April 20, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Determine if confocal endoscopic microscopy (CEM) affords greater sensitivity for detection of SRC foci in CDH1 germline mutation carriers compared to the current method of standard white light endoscopy [ Time Frame: 14 days ] Determine if confocal endoscopic microscopy (CEM) affords greater sensitivity for detection of SRC foci in CDH1 germline mutation carriers compared to the current method of standard white light endoscopy
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
Define the false negative rate of CEM detection of SRC foci in those patients who choose to undergo prophylactic total gastrectomy with permanent pathologic analysis [ Time Frame: 14 days ] In patients who choose to undergo prophylactic total gastrectomy with permanent pathologic analysis, the false negative rate (the fraction of patients who have SRC foci not identified by CEM) will be determined and reported
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Original Secondary Outcome Measures ICMJE | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Confocal Endoscopic Microscopy for Detection of Early Stage Gastric Cancer in Subjects With Hereditary Diffuse Gastric Cancer Syndrome | ||||
Official Title ICMJE | Phase II Study Evaluating Confocal Endoscopic Microscopy for Detection of Early Stage Gastric Cancer in Subjects With Hereditary Diffuse Gastric Cancer Syndrome | ||||
Brief 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:
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. |
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Detailed Description | Background: Hereditary Diffuse Gastric Cancer (HDGC) syndrome is caused by a germline mutation in the CDH1 gene. Carriers of this mutation have a 56-70% lifetime risk of developing gastric adenocarcinoma. Current international guidelines recommend endoscopic screening of CDH1 mutation carriers that consists of systematic biopsies of an otherwise normal appearing stomach. However, this approach lacks sufficient sensitivity for detecting intramucosal foci of signet ring cells (SRC), which are pathognomonic of HDGC syndrome. The goal of the current study is to utilize confocal endoscopic microscopy (CEM) for screening the gastric mucosa in this high-risk population. Objective: Determine if confocal endoscopic microscopy (CEM) will afford greater sensitivity for detection of SRC foci in CDH1 germline mutation carriers. Eligibility: CDH1 germline mutation carriers, or those who meet clinical criteria for HDGC testing but have tested negative for a CDH1 gene mutation or those who have other germline mutations suspected to be, or reported to be, associated with HDGC (e.g. CTNNA1). Design: Phase II, single-institution study of CEM for detection of intramucosal SRC foci compared to current systematic gastric mapping procedure. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Diagnostic |
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Condition ICMJE |
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Intervention ICMJE | Device: Endoscope+Cellvizio(R) 100 microscope
Patients will undergo white-light, upper endoscopy. In addition, during this endoscopy patients will undergo CEM using the Cellvizio probe (Mauna Kea Technologies) to scan the same anatomic zones.
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Study Arms ICMJE | Experimental: 1/Arm 1
Upper white-light endoscopy and confocal endoscopic microscopy
Intervention: Device: Endoscope+Cellvizio(R) 100 microscope
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Publications * | Ruff S, Curtin B, Quezado M, Heller T, Koh C, Steinberg SM, Connolly M, Hernandez JM, Davis JL. Evaluation of confocal endoscopic microscopy for detection of early-stage gastric cancer in hereditary diffuse gastric cancer (HDGC) syndrome. J Gastrointest Oncol. 2019 Jun;10(3):407-411. doi: 10.21037/jgo.2019.01.04. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
37 | ||||
Original Estimated Enrollment ICMJE |
27 | ||||
Actual Study Completion Date ICMJE | May 5, 2020 | ||||
Actual Primary Completion Date | April 20, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
or -Patients with CTNNA1 and PALB2 germline mutations suspected to be, or reported to be, associated with HDGC or
EXCLUSION CRITERIA:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03648879 | ||||
Other Study ID Numbers ICMJE | 180141 18-C-0141 |
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Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ) | ||||
Study Sponsor ICMJE | National Cancer Institute (NCI) | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | National Institutes of Health Clinical Center (CC) | ||||
Verification Date | July 30, 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |