Gastric Epithelial Neoplasm of Fundic-gland MucosaNCT07230054
Clinicopathological Features and Treatment Strategies for Gastric Epithelial Neoplasm of Fundic-gland Mucosa Lineage
An observational study of Gastric Epithelial Neoplasm of Fundic-gland Mucosa, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
Gastric epithelial neoplasm of fundic-gland mucosa lineage (GEN-FGML) is a rare pathological type of gastric cancer characterized by unique endoscopic features, including specific morphology, color, and changes in the surface and vascular patterns of the lesion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Epithelial Neoplasm of Fundic-gland Mucosa
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2010to 1 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who confirmed diagnosis of GEN-FGML
Who may be able to join
- Patients who voluntarily provided written informed consent between August 1, 2010 and August 1, 2024
- Age ≥18 years at diagnosis
- Confirmed diagnosis of GEN-FGML
Who cannot join
- The clinicopathological data of the lesion(s) were missing
Trial locations and contacts
1 site in 1 country.
China1 site
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515
About this study
Official title: Clinicopathological Features and Treatment Strategies for Gastric Epithelial Neoplasm of Fundic-gland Mucosa Lineage: A Multicenter Retrospective Study
Gastric epithelial neoplasm of fundic-gland mucosa lineage (GEN-FGML) is a rare pathological type of gastric cancer characterized by unique endoscopic features, including specific morphology, color, and changes in the surface and vascular patterns of the lesion. Histologically, GEN-FGML is an epithelial neoplasm exhibiting gastric fundic gland differentiation. Based on cellular differentiation and submucosal invasion, it can be classified into three subtypes:
- Oxyntic gland adenoma (OGA);
- Gastric adenocarcinoma of fundic-gland type (GA-FG);
- Gastric adenocarcinoma of fundic-gland mucosa type (GA-FGM). GA-FGM can be further subdivided into three subtypes: Type 1 (regular exposed pattern), Type 2 (disordered exposed pattern), and Type 3 (disordered non-exposed pattern).
Read more
Some studies have analyzed the clinicopathological characteristics, endoscopic features, molecular biological characteristics, treatment strategies, and prognosis of the different GEN-FGML subtypes. Generally, OGA and GA-FG present as low-grade epithelial neoplasms with a favorable prognosis, whereas GA-FGM exhibits higher rates of lymphovascular invasion and behaves as a high-grade malignant tumor.However, due to the currently limited number of reported cases, there are no international guidelines or consensus regarding the selection of treatment strategies for GEN-FGML, curative resection evaluation, and prognosis.
In this study, the investigators aim to retrospectively collect data on GEN-FGML cases from multiple centers in China and compare the clinicopathological characteristics, molecular biological features, endoscopic characteristics, treatment strategies, and patient prognosis among the different GEN-FGML subtypes.
Read the detailed description
- Research Background
Gastric epithelial neoplasm of fundic-gland mucosa lineage (GEN-FGML) is a rare pathological type of gastric cancer characterized by unique endoscopic features, including specific morphology, color, and changes in the surface and vascular patterns of the lesion. In 2007, Tsukamoto et al. reported the first case of gastric adenocarcinoma with chief cell differentiation. In 2010, Ueyama et al. proposed gastric adenocarcinoma of fundic-gland type (GA-FG) as a novel variant of gastric adenocarcinoma. Subsequently, gastric adenocarcinoma of fundic-gland mucosa type (GA-FGM) was also reported; this subtype exhibits gastric foveolar epithelial differentiation in addition to fundic gland differentiation and demonstrates more aggressive behavior.Histologically, GEN-FGML is an epithelial neoplasm exhibiting gastric fundic gland differentiation. Based on cellular differentiation and submucosal invasion, it can be classified into three subtypes:
- Oxyntic gland adenoma (OGA);
- Gastric adenocarcinoma of fundic-gland type (GA-FG);
- Gastric adenocarcinoma of fundic-gland mucosa type (GA-FGM). GA-FGM can be further subdivided into three subtypes: Type 1 (regular exposed pattern), Type 2 (disordered exposed pattern), and Type 3 (disordered non-exposed pattern).
Some studies have analyzed the clinicopathological characteristics, endoscopic features, molecular biological characteristics, treatment strategies, and prognosis of the different GEN-FGML subtypes. Generally, OGA and GA-FG present as low-grade epithelial neoplasms with a favorable prognosis, whereas GA-FGM exhibits higher rates of lymphovascular invasion and behaves as a high-grade malignant tumor.
However, due to the currently limited number of reported cases, there are no international guidelines or consensus regarding the selection of treatment strategies for GEN-FGML, curative resection evaluation, and prognosis. Furthermore, the majority of reported cases have been described by Japanese researchers, and data on the incidence, detection rate, treatment strategies, and clinical prognosis of GEN-FGML in other countries remain scarce.
Based on this, there is an urgent need for systematic research into the clinicopathological characteristics, endoscopic features, treatment strategies, and prognosis of GEN-FGML. This study aims to provide high-quality, evidence-based medical evidence to inform the development of standardized treatment strategies, curative evaluation, and prognostic assessment for GEN-FGML. Specifically, the investigators aim to retrospectively collect data on GEN-FGML cases from multiple centers in China and compare the clinicopathological characteristics, molecular biological features, endoscopic characteristics, treatment strategies, and patient prognosis among the different GEN-FGML subtypes.
- Research Objectives
The objectives of this study are to:
- Retrospectively collect cases and clinical data related to GEN-FGML from multiple centers across China.
- Compare the clinicopathological characteristics, endoscopic features, molecular biological characteristics, clinical treatment modalities, and patient prognosis among the different subtypes of GEN-FGML.
- Provide high-quality, evidence-based data to support the development of standardized treatment strategies, curative resection evaluation, and prognostic assessment for GEN-FGML.
- Keywords
- Gastric epithelial neoplasm of fundic-gland mucosa lineage, oxyntic gland adenoma, gastric adenocarcinoma of fundic-gland type, gastric adenocarcinoma of fundic-gland mucosa type
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| oxyntic gland adenoma | Cases were diagnosed as OGA according to the histological and immunohistochemical diagnostic criteria for low-grade dysplasia and differentiated gastric cancer established in previous studies. | |
| gastric adenocarcinoma of fundic-gland type | Cases were diagnosed as GA-FG according to the histological and immunohistochemical diagnostic criteria for low-grade dysplasia and differentiated gastric cancer established in previous studies. | |
| gastric adenocarcinoma of fundic-gland mucosa type | Cases were diagnosed as GA-FGM according to the histological and immunohistochemical diagnostic criteria for low-grade dysplasia and differentiated gastric cancer established in previous studies. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Clinicopathological Characteristics Among Different Subtypes of GEN-FGML
Data extracted from Electronic Medical Records (EMRs):
Imaging Results (CT)
Measured: From enrollment to the end of treatment at 2 years
Comparison of Clinicopathological Characteristics Among Different Subtypes of GEN-FGML
Endoscopic Findings(presence of atrophic gastritis, lesion location, lesion size, lesion color, gross morphology of the lesion, presence of lesion borders, presence of mucosal atrophy around the lesion, presence of dilated branching vessels, regularity of lesion color, regularity of the mucosal structure on the lesion surface, presence of granular changes in the lesion mucosa)
Measured: From enrollment to the end of treatment at 2 years
Comparison of Clinicopathological Characteristics Among Different Subtypes of GEN-FGML
Histopathological Results[the type of GEN-FGML:OGA, GA-FG, GA-FGM. result of immunohistochemistry(positve or negative): MUC5AC, MUC6, MUC2, CD10, p53, H+K+-ATP，Ki-67]
Measured: From enrollment to the end of treatment at 2 years
Comparison of Therapeutic Approaches Among Different Subtypes of GEN-FGML
Treatment Modalities(Endoscopic forceps removal, cold resection, snare electrosurgical resection, endoscopic mucosal resection, endoscopic submucosal dissection , surgical surgery）
Measured: From enrollment to the end of treatment at 2 years
Comparison of Prognosis Among Different Subtypes of GEN-FGML
Surveillance（including Endoscopic Surveillance and Imaging Surveillance )
Measured: From enrollment to the end of treatment at 2 years
Secondary outcomes (1)
Medical of GEN-FGML Patients.
Data extracted from Electronic Medical Records (EMRs): Medical History（age、clinical symtoms such as acid reflux, heartburn, and abdominal pain)
Measured: From enrollment to the end of treatment at 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start1 Aug 2010
- Primary completion1 Aug 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Epithelial Neoplasm of Fundic-gland MucosaStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07230054
- Sponsor's protocol ID
- NFEC-2024-644
- Status last verified
- Nov 2025
- First submitted
- 22 Jul 2025
- Last updated
- 17 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinicopathological Features and Treatment Strategies for Gastric Epithelial Neoplasm of Fundic-gland Mucosa Lineage: A Multicenter Retrospective Study
- ClinicalTrials.gov ID
- NCT07230054
- Acronym / sponsor ID
- NFEC-2024-644
- Keywords
- Gastric epithelial neoplasm of fundic-gland mucosa lineage, oxyntic gland adenoma, gastric adenocarcinoma of fundic-gland type, gastric adenocarcinoma of fundic-gland mucosa type
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2010 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 17 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Gastric epithelial neoplasm of fundic-gland mucosa lineage (GEN-FGML) is a rare pathological type of gastric cancer characterized by unique endoscopic features, including specific morphology, color, and changes in the surface and vascular patterns of the lesion. Histologically, GEN-FGML is an epithelial neoplasm exhibiting gastric fundic gland differentiation. Based on cellular differentiation and submucosal invasion, it can be classified into three subtypes:
- Oxyntic gland adenoma (OGA);
- Gastric adenocarcinoma of fundic-gland type (GA-FG);
- Gastric adenocarcinoma of fundic-gland mucosa type (GA-FGM). GA-FGM can be further subdivided into three subtypes: Type 1 (regular exposed pattern), Type 2 (disordered exposed pattern), and Type 3 (disordered non-exposed pattern).
Some studies have analyzed the clinicopathological characteristics, endoscopic features, molecular biological characteristics, treatment strategies, and prognosis of the different GEN-FGML subtypes. Generally, OGA and GA-FG present as low-grade epithelial neoplasms with a favorable prognosis, whereas GA-FGM exhibits higher rates of lymphovascular invasion and behaves as a high-grade malignant tumor.However, due to the currently limited number of reported cases, there are no international guidelines or consensus regarding the selection of treatment strategies for GEN-FGML, curative resection evaluation, and prognosis.
In this study, the investigators aim to retrospectively collect data on GEN-FGML cases from multiple centers in China and compare the clinicopathological characteristics, molecular biological features, endoscopic characteristics, treatment strategies, and patient prognosis among the different GEN-FGML subtypes.
Detailed description
- Research Background
Gastric epithelial neoplasm of fundic-gland mucosa lineage (GEN-FGML) is a rare pathological type of gastric cancer characterized by unique endoscopic features, including specific morphology, color, and changes in the surface and vascular patterns of the lesion. In 2007, Tsukamoto et al. reported the first case of gastric adenocarcinoma with chief cell differentiation. In 2010, Ueyama et al. proposed gastric adenocarcinoma of fundic-gland type (GA-FG) as a novel variant of gastric adenocarcinoma. Subsequently, gastric adenocarcinoma of fundic-gland mucosa type (GA-FGM) was also reported; this subtype exhibits gastric foveolar epithelial differentiation in addition to fundic gland differentiation and demonstrates more aggressive behavior.Histologically, GEN-FGML is an epithelial neoplasm exhibiting gastric fundic gland differentiation. Based on cellular differentiation and submucosal invasion, it can be classified into three subtypes:
- Oxyntic gland adenoma (OGA);
- Gastric adenocarcinoma of fundic-gland type (GA-FG);
- Gastric adenocarcinoma of fundic-gland mucosa type (GA-FGM). GA-FGM can be further subdivided into three subtypes: Type 1 (regular exposed pattern), Type 2 (disordered exposed pattern), and Type 3 (disordered non-exposed pattern).
Some studies have analyzed the clinicopathological characteristics, endoscopic features, molecular biological characteristics, treatment strategies, and prognosis of the different GEN-FGML subtypes. Generally, OGA and GA-FG present as low-grade epithelial neoplasms with a favorable prognosis, whereas GA-FGM exhibits higher rates of lymphovascular invasion and behaves as a high-grade malignant tumor.
However, due to the currently limited number of reported cases, there are no international guidelines or consensus regarding the selection of treatment strategies for GEN-FGML, curative resection evaluation, and prognosis. Furthermore, the majority of reported cases have been described by Japanese researchers, and data on the incidence, detection rate, treatment strategies, and clinical prognosis of GEN-FGML in other countries remain scarce.
Based on this, there is an urgent need for systematic research into the clinicopathological characteristics, endoscopic features, treatment strategies, and prognosis of GEN-FGML. This study aims to provide high-quality, evidence-based medical evidence to inform the development of standardized treatment strategies, curative evaluation, and prognostic assessment for GEN-FGML. Specifically, the investigators aim to retrospectively collect data on GEN-FGML cases from multiple centers in China and compare the clinicopathological characteristics, molecular biological features, endoscopic characteristics, treatment strategies, and patient prognosis among the different GEN-FGML subtypes.
- Research Objectives
The objectives of this study are to:
- Retrospectively collect cases and clinical data related to GEN-FGML from multiple centers across China.
- Compare the clinicopathological characteristics, endoscopic features, molecular biological characteristics, clinical treatment modalities, and patient prognosis among the different subtypes of GEN-FGML.
- Provide high-quality, evidence-based data to support the development of standardized treatment strategies, curative resection evaluation, and prognostic assessment for GEN-FGML.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| oxyntic gland adenoma | – | –Cases were diagnosed as OGA according to the histological and immunohistochemical diagnostic criteria for low-grade dysplasia and differentiated gastric cancer established in previous studies. |
| gastric adenocarcinoma of fundic-gland type | – | –Cases were diagnosed as GA-FG according to the histological and immunohistochemical diagnostic criteria for low-grade dysplasia and differentiated gastric cancer established in previous studies. |
| gastric adenocarcinoma of fundic-gland mucosa type | – | –Cases were diagnosed as GA-FGM according to the histological and immunohistochemical diagnostic criteria for low-grade dysplasia and differentiated gastric cancer established in previous studies. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who confirmed diagnosis of GEN-FGML
Key inclusion criteria (3 listed)
- Patients who voluntarily provided written informed consent between August 1, 2010 and August 1, 2024
- Age ≥18 years at diagnosis
- Confirmed diagnosis of GEN-FGML
Key exclusion criteria (1 listed)
- The clinicopathological data of the lesion(s) were missing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparison of Clinicopathological Characteristics Among Different Subtypes of GEN-FGML
Time frame: From enrollment to the end of treatment at 2 years
Data extracted from Electronic Medical Records (EMRs): Imaging Results (CT)
Comparison of Clinicopathological Characteristics Among Different Subtypes of GEN-FGML
Time frame: From enrollment to the end of treatment at 2 years
Endoscopic Findings(presence of atrophic gastritis, lesion location, lesion size, lesion color, gross morphology of the lesion, presence of lesion borders, presence of mucosal atrophy around the lesion, presence of dilated branching vessels, regularity of lesion color, regularity of the mucosal structure on the lesion surface, presence of granular changes in the lesion mucosa)
Comparison of Clinicopathological Characteristics Among Different Subtypes of GEN-FGML
Time frame: From enrollment to the end of treatment at 2 years
Histopathological Results[the type of GEN-FGML:OGA, GA-FG, GA-FGM. result of immunohistochemistry(positve or negative): MUC5AC, MUC6, MUC2, CD10, p53, H+K+-ATP，Ki-67]
Comparison of Therapeutic Approaches Among Different Subtypes of GEN-FGML
Time frame: From enrollment to the end of treatment at 2 years
Treatment Modalities(Endoscopic forceps removal, cold resection, snare electrosurgical resection, endoscopic mucosal resection, endoscopic submucosal dissection , surgical surgery）
Comparison of Prognosis Among Different Subtypes of GEN-FGML
Time frame: From enrollment to the end of treatment at 2 years
Surveillance（including Endoscopic Surveillance and Imaging Surveillance )
1 secondary outcome
Medical of GEN-FGML Patients.
Time frame: From enrollment to the end of treatment at 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Epithelial Neoplasm of Fundic-gland Mucosa, run by Nanfang Hospital, Southern Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of Clinicopathological Characteristics Among Different Subtypes of GEN-FGML (time frame: From enrollment to the end of treatment at 2 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.