Confocal Endoscopic Microscopy for Detection of Early Stage Gastric Cancer in Subjects With Hereditary Diffuse Gastric Cancer Syndrome
| Status: | Recruiting |
|---|---|
| Conditions: | Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 99 |
| Updated: | 4/4/2019 |
| Start Date: | February 11, 2019 |
| End Date: | December 31, 2021 |
| Contact: | NIH Foregut Team |
| Email: | foregut@mail.nih.gov |
| Phone: | (240) 858-3610 |
Phase II Study Evaluating 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 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.
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.
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.
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.
- INCLUSION CRITERIA:
- Patients with CDH1 germline mutation known to be pathogenic or likely pathogenic,
which may also be classified as "significant" or "likely significant" (patients with
variants of "uncertain significance " are excluded)
or
-Patients with CTNNA1 and PALB2 germline mutations suspected to be, or reported to be,
associated with HDGC
or
- In the absence of a germline CDH1 mutation, patients must meet clinical criteria for
genetic testing due to a history suggestive of Hereditary Diffuse Gastric Cancer
(HDGC) syndrome
- Age greater than or equal to 18 years.
- Physiologically able to undergo upper endoscopy.
- Ability to understand and the willingness to sign a written informed consent document.
- Pregnant women are eligible during second trimester of pregnancy if clinically
indicated for evaluation of cancer.
EXCLUSION CRITERIA:
- Current use of therapeutic anticoagulation medication
- Known bleeding disorder or thrombocytopenia
- Unstable angina or recent (within 3 months) myocardial infarction
- Any clinical contraindication to general anesthesia
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
301-496-2563
Phone: 888-624-1937
National Institutes of Health Clinical Center The National Institutes of Health (NIH) Clinical Center in...
Click here to add this to my saved trials
