Gastric CarcinomaNCT05811546
Immunohistochemical Evaluation of DNA Methylation and Histone Modification in H. Pylori Associated Gastric Carcinoma
An observational study of Gastric Carcinoma, run by Assiut University at 1 site in Egypt.
Trial summary
The goal of this cross-sectional study is to evaluate epigenetic modifications in gastric carcinogenesis, mainly in H. pylori gastritis vs gastric carcinoma. The main question[s] it aims to answer are: How does H. Read more about this study
- Who is it for?
- Ages 30 to 100 years
- Conditions the study is for
- Gastric Carcinoma
- What is being tested?
- Immunohistochemical staining for DNMT1 and EZH2
- How many people
- 68 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2022to 31 Dec 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 30 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Formalin-fixed-paraffin-embedded tissue blocks from resected specimens and endoscopic guided biopsies of intestinal type gastric carcinoma, H. Pylori associated gastritis, and non-H. Pylori gastritis.
Who may be able to join
- Resected specimens and endoscopic guided biopsies of intestinal type gastric carcinoma, H. Pylori associated gastritis, and non-H. Pylori gastritis with:
- Available full clinical data: (age, sex, complaint, findings in clinical examination).
- Full data of previous endoscopy and radiology.
Who cannot join
- Cases of diffuse type gastric carcinoma.
- Any case of gastric cancer, H. Pylori associated gastritis, non-H. Pylori gastritis, benign gastric lesions with missing clinical, endoscopic, radiologic or follow-up data.
- Cases with no available H\&E stained slides or formalin fixed paraffin embedded block.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assiut University
Asyut, 71515
Mahmoud Sherif, Phd, +20 1002763939, m.farouk.pathology@aun.edu.eg
About this study
The goal of this cross-sectional study is to evaluate epigenetic modifications in gastric carcinogenesis, mainly in H. pylori gastritis vs gastric carcinoma. The main question[s] it aims to answer are:
- How does H. pylori infection cause gastric cancer?
- Can DNA methylation and other epigenetic changes predict and affect the development of gastric cancer? Formalin-fixed-paraffin-embedded tissue specimens will be obtained and reviewed for comparison between epigenetic changes in H. pylori gastritis and gastric adenocarcinoma.
- Conditions
- Gastric Carcinoma
- Being tested
- Immunohistochemical staining for DNMT1 and EZH2
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunohistochemical staining for DNMT1 and EZH2Diagnostic test
Immunohistochemical staining for DNMT1 and EZH2 using rabbit monoclonal/polycolonal antibodies with immunoperoxidase staining will be used as a visualization method. Antibodies dilutions, antigen retrieval methods, and incubation time will all be conducted according to the manufacturer's instructions.
| Study group | Role | What they receive |
|---|---|---|
| H. pylori Gastritis specimens | Not described Receives: Diagnostic Test: Immunohistochemical staining for DNMT1 and EZH2 | |
| Non-H. pylori Gastritis specimens | Not described | |
| Gastric carcinoma specimens | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in DNMT1 and EZH2 expression.
Histopathological evaluation of routine H\&E slides and immunohistochemical markers to compare the intensity and extent of epigenetic changes in both H. Pylori associated gastritis and gastric carcinoma.
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2023
- Study start1 May 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CarcinomaStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aliyah Soliman Ali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05811546
- Sponsor's protocol ID
- Epigenetics Gastric Carcinoma
- Status last verified
- Mar 2023
- First submitted
- 31 Mar 2023
- Last updated
- 13 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunohistochemical Evaluation of DNA Methylation and Histone Modification in H. Pylori Associated Gastric Carcinoma
- ClinicalTrials.gov ID
- NCT05811546
- Acronym / sponsor ID
- Epigenetics Gastric Carcinoma
- Conditions
- Gastric Carcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 13 Apr 2023 (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.
The goal of this cross-sectional study is to evaluate epigenetic modifications in gastric carcinogenesis, mainly in H. pylori gastritis vs gastric carcinoma. The main question[s] it aims to answer are:
- How does H. pylori infection cause gastric cancer?
- Can DNA methylation and other epigenetic changes predict and affect the development of gastric cancer? Formalin-fixed-paraffin-embedded tissue specimens will be obtained and reviewed for comparison between epigenetic changes in H. pylori gastritis and gastric adenocarcinoma.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| H. pylori Gastritis specimens | – | Diagnostic Test: Immunohistochemical staining for DNMT1 and EZH2 |
| Non-H. pylori Gastritis specimens | – | – |
| Gastric carcinoma specimens | – | – |
Who may qualify
- Ages
- 30 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Formalin-fixed-paraffin-embedded tissue blocks from resected specimens and endoscopic guided biopsies of intestinal type gastric carcinoma, H. Pylori associated gastritis, and non-H. Pylori gastritis.
Key inclusion criteria (3 listed)
- Resected specimens and endoscopic guided biopsies of intestinal type gastric carcinoma, H. Pylori associated gastritis, and non-H. Pylori gastritis with:
- Available full clinical data: (age, sex, complaint, findings in clinical examination).
- Full data of previous endoscopy and radiology.
Key exclusion criteria (3 listed)
- Cases of diffuse type gastric carcinoma.
- Any case of gastric cancer, H. Pylori associated gastritis, non-H. Pylori gastritis, benign gastric lesions with missing clinical, endoscopic, radiologic or follow-up data.
- Cases with no available H\&E stained slides or formalin fixed paraffin embedded block.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immunohistochemical staining for DNMT1 and EZH2Immunohistochemical staining for DNMT1 and EZH2 using rabbit monoclonal/polycolonal antibodies with immunoperoxidase staining will be used as a visualization method. Antibodies dilutions, antigen retrieval methods, and incubation time will all be conducted according to the manufacturer's instructions. | Diagnostic test | H. pylori Gastritis specimens |
Primary outcome
Difference in DNMT1 and EZH2 expression.
Time frame: two years
Histopathological evaluation of routine H\&E slides and immunohistochemical markers to compare the intensity and extent of epigenetic changes in both H. Pylori associated gastritis and gastric carcinoma.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
- Individual participant dataSharing planned: No
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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.
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 Carcinoma, run by Assiut University at 1 site in Egypt.
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 3 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: status not confirmed, as of the sponsor's last update on 13 Apr 2023. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in DNMT1 and EZH2 expression. (time frame: two years). 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 13 Apr 2023.