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
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.
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.
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
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.
|Condition or disease||Intervention/treatment||Phase|
|Gastric Cancer Gastric Neoplasms||Device: Endoscope+Cellvizio(R) 100 microscope||Phase 2|
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.
Determine if confocal endoscopic microscopy (CEM) will afford greater sensitivity for detection of SRC foci in CDH1 germline mutation carriers.
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).
Phase II, single-institution study of CEM for detection of intramucosal SRC foci compared to current systematic gastric mapping procedure.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study Evaluating Confocal Endoscopic Microscopy for Detection of Early Stage Gastric Cancer in Subjects With Hereditary Diffuse Gastric Cancer Syndrome|
|Actual Study Start Date :||February 11, 2019|
|Actual Primary Completion Date :||April 20, 2020|
|Actual Study Completion Date :||May 5, 2020|
Experimental: 1/Arm 1
Upper white-light endoscopy and confocal endoscopic microscopy
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.
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03648879
|United States, Maryland|
|National Institutes of Health Clinical Center|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Jeremy L Davis, M.D.||National Cancer Institute (NCI)|