Gastric CancerNCT03894384
The Value of TFF3 in Diagnosis of Gastric Cancer
An observational study of Gastric Cancer, run by Assiut University at 1 site in Egypt.
Trial summary
Gastric cancer (GC), is a cancer developing from the inner lining of the stomach .The most common cause is infection by the bacterium Helicobacter pylori,which accounts for 60% of cases. Read more about this study
- Who is it for?
- Ages 15 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Trefoil factor family 3 (TFF3),Pepsinogen 1(PG1)
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2019to 1 Nov 2022
- 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 15 to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: This study will be conducted on 90 informed individuals (according to the guidelines of ethical committee of faculty of Medicine, Assiut University and South Egypt Cancer Institute).
Who may be able to join
- Includes all patients presented by gastric cancer with clinical, radiological, laboratory diagnosis and pathological diagnosis.
- Individuals with benign diseases such as gastric polyps ,leiomyomas, gastric ulcers, atrophic gastritis and gastritis clinical, radiological, laboratory and pathological diagnosis.
Who cannot join
- - Previous upper gastrointestinal surgery, patients with gastric cancer that had been received chemotherapy, radiotherapy or surgical treatment.
- Patients simultaneously presented with a malignancy other than that of the stomach (Breast, pancreatic or colorectal).
- Pateints with severe systemic co-morbidities such as cardiopulmonary,hepatic and renal diseases
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Melouk Ahmed Mahmoud
Asyut
Melouk Ahmed, Dr, 01061884390, meloukahme1987@gmail.com
About this study
Official title: The Value of Serum Trefoil Factor Family 3 (TFF3) in Diagnosis of Gastric Cancer
Gastric cancer (GC), is a cancer developing from the inner lining of the stomach .The most common cause is infection by the bacterium Helicobacter pylori,which accounts for 60% of cases.
Human pepsinogens (HP) are proenzymes for pepsin; digestive enzymes produced by gastric chief cells, classified into two groups: pepsinogen I (PGI) and pepsinogen II (PGII), humen pepsinogens considered promising serological biomarkers for the screening of atrophic gastritis and gastric cancer.
The trefoil factor family (TFF) of peptides comprises small (12-22kDa) molecules that are secreted by the mammalian gastro-intestinal tract.Trefoil factor family 3 (TFF3) is a more stable non invasive biomarker of gastric cancer risk even in early gastric cancer.
Read the detailed description
Gastric cancer (GC), is a cancer developing from the inner lining of the stomach.Approximately half of the gastric cancer cases are diagnosed during advanced stages. One of the reasons for this is the invasiveness of esophagogastroduodenoscopy (EGD) screening examinations that leads to patients avoiding necessary tests .
The most common cause is infection by the bacterium Helicobacter pylori (H.pylori),which accounts for 60% of cases.
The development of tools for the early diagnosis of gastric cancer and precancerous lesions of gastric cancer is important for reducing mortality, increasing survival rates, and improving quality of life.
Endoscopy and biopsy are the reference standards for diagnosis and screening of gastric cancer, but their use is limited for population-wide screening due to their invasiveness.Subsequently, it is necessary to identify novel, simple, cost-effective and manipulable screening methods for gastric cancer.
Human pepsinogens (HP) are proenzymes for pepsin, a digestive enzymes produced by gastric chief cells,biochemically and immunochemically classified into two groups: pepsinogen I (PGI) and pepsinogen II (PGII), humen pepsinogens considered promising serological biomarkers for the screening of atrophic gastritis and gastric cancer,serum pepsinogen test provides a valuable method for detecting gastric cancer and atrophic gastritis.
The limitation of the pepsinogen test as a non invasive serologic biomarker screening method is that the optimal cut-off value could be affected by several factors, age, gender, and the test method itself.
The trefoil factor family (TFF) of peptides comprises small (12-22kDa) molecules that are secreted by the mammalian gastro-intestinal tract. TFFs constitute a family of three peptides (TFF1, TFF2, and TFF3) that are widely expressed in a tissue-specific manner in the gastro- intestinal tract. Trefoil factor family 3 (TFF3) is expressed in the goblet cells of the small and large intestines as well as the intestinal metaplasia in the stomach.
The trefoil factor family (TFF) plays a key role in the maintenance of mucosal integrity, and plays an impotant role in oncogenic transformation, growth, and metastatic extension of common human solid tumors, including gastric cancer.
SerumTFF3 showed good diagnostic power in both of H. pylori positive and H. pylori-negative gastric cancer and its serum levels were significantly higher in patients with advanced gastric cancer than that in patients with early gastric cancer.
- pylori organisms live in gastric mucosa, and attach to epithelial cells of stomach .Because trefoil factor family 3 is not expressed in epithelial cells of the stomach and is only expressed in the intestinal goblet cells of the metaplasia of gastric cancer , serum trefoil factor family 3 levels are less influenced by H. pylori infection , eradication, aging, and sex ,therefore, serum trefoil factor family 3 is a more stable non invasive biomarker of gastric cancer risk even in early gastric cancer.
- Conditions
- Gastric Cancer
- Being tested
- Trefoil factor family 3 (TFF3),Pepsinogen 1(PG1)
- Keywords
- TFF3, PG1
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trefoil factor family 3 (TFF3),Pepsinogen 1(PG1)Diagnostic test
Diagnostic Test: A) CBC . B) FBG. C)KFT. D) LFT. A)CBC: Complete blood count. B)FBG: Fasting blood glucose. C)KFT: Kidney function tests. D)LFT: Liver function tests.
| Study group | Role | What they receive |
|---|---|---|
| Group:1 | Gastric cancer patients Receives: Diagnostic Test: Trefoil factor family 3 (TFF3),Pepsinogen 1(PG1) | |
| Group:2 | Patients with benign gastric diseases Receives: Diagnostic Test: Trefoil factor family 3 (TFF3),Pepsinogen 1(PG1) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic value of trefoil factor family 3 (TFF3) in serum of gastric cancer as non invasive marker
Measurement of TFF3 by enzyme linked immunosorbent assay (ELISA) in serum of gastric cancer patients
Measured: 2 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2019
- Study start1 Dec 2019
- Primary completion1 Nov 2021 (estimated)
- Study completion1 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melouk Ahmed, Assiut University
- Investigators
- Heba Ahmed, MD, Principal investigator, Assiut UniversityEbtesam Farouk, MD, Study chair, Assiut UniversityAbeer Ahmed, MD, Study chair, Assiut UniversityMelouk Ahmed, Dr, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03894384
- Sponsor's protocol ID
- TFF3 in gastric cancer
- Status last verified
- Mar 2019
- First submitted
- 27 Mar 2019
- Last updated
- 9 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Choi IJ. Endoscopic gastric cancer screening and surveillance in high-risk groups. Clin Endosc. 2014 Nov;47(6):497-503. doi: 10.5946/ce.2014.47.6.497. Epub 2014 Nov 30.
PubMed 25505714Lee JY, Park KS, Lee HG, Baek WK, Cho KB, Lee YJ, Lee YS, Ryu SW. Comparison of serum trefoil factor 3 with the pepsinogen test for the screening of diffuse-type gastric cancer. Clin Exp Med. 2017 Aug;17(3):403-410. doi: 10.1007/s10238-016-0426-1. Epub 2016 May 6.
PubMed 27154568Xiao P, Ling H, Lan G, Liu J, Hu H, Yang R. Trefoil factors: Gastrointestinal-specific proteins associated with gastric cancer. Clin Chim Acta. 2015 Oct 23;450:127-34. doi: 10.1016/j.cca.2015.08.004. Epub 2015 Aug 8.
PubMed 26265233
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of Serum Trefoil Factor Family 3 (TFF3) in Diagnosis of Gastric Cancer
- ClinicalTrials.gov ID
- NCT03894384
- Acronym / sponsor ID
- TFF3 in gastric cancer
- Conditions
- Gastric Cancer
- Keywords
- TFF3, PG1
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 1 Nov 2021 (estimated)
- Study completion
- 1 Nov 2022 (estimated)
- First posted
- 28 Mar 2019 (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 cancer (GC), is a cancer developing from the inner lining of the stomach .The most common cause is infection by the bacterium Helicobacter pylori,which accounts for 60% of cases.
Human pepsinogens (HP) are proenzymes for pepsin; digestive enzymes produced by gastric chief cells, classified into two groups: pepsinogen I (PGI) and pepsinogen II (PGII), humen pepsinogens considered promising serological biomarkers for the screening of atrophic gastritis and gastric cancer.
The trefoil factor family (TFF) of peptides comprises small (12-22kDa) molecules that are secreted by the mammalian gastro-intestinal tract.Trefoil factor family 3 (TFF3) is a more stable non invasive biomarker of gastric cancer risk even in early gastric cancer.
Detailed description
Gastric cancer (GC), is a cancer developing from the inner lining of the stomach.Approximately half of the gastric cancer cases are diagnosed during advanced stages. One of the reasons for this is the invasiveness of esophagogastroduodenoscopy (EGD) screening examinations that leads to patients avoiding necessary tests .
The most common cause is infection by the bacterium Helicobacter pylori (H.pylori),which accounts for 60% of cases.
The development of tools for the early diagnosis of gastric cancer and precancerous lesions of gastric cancer is important for reducing mortality, increasing survival rates, and improving quality of life.
Endoscopy and biopsy are the reference standards for diagnosis and screening of gastric cancer, but their use is limited for population-wide screening due to their invasiveness.Subsequently, it is necessary to identify novel, simple, cost-effective and manipulable screening methods for gastric cancer.
Human pepsinogens (HP) are proenzymes for pepsin, a digestive enzymes produced by gastric chief cells,biochemically and immunochemically classified into two groups: pepsinogen I (PGI) and pepsinogen II (PGII), humen pepsinogens considered promising serological biomarkers for the screening of atrophic gastritis and gastric cancer,serum pepsinogen test provides a valuable method for detecting gastric cancer and atrophic gastritis.
The limitation of the pepsinogen test as a non invasive serologic biomarker screening method is that the optimal cut-off value could be affected by several factors, age, gender, and the test method itself.
The trefoil factor family (TFF) of peptides comprises small (12-22kDa) molecules that are secreted by the mammalian gastro-intestinal tract. TFFs constitute a family of three peptides (TFF1, TFF2, and TFF3) that are widely expressed in a tissue-specific manner in the gastro- intestinal tract. Trefoil factor family 3 (TFF3) is expressed in the goblet cells of the small and large intestines as well as the intestinal metaplasia in the stomach.
The trefoil factor family (TFF) plays a key role in the maintenance of mucosal integrity, and plays an impotant role in oncogenic transformation, growth, and metastatic extension of common human solid tumors, including gastric cancer.
SerumTFF3 showed good diagnostic power in both of H. pylori positive and H. pylori-negative gastric cancer and its serum levels were significantly higher in patients with advanced gastric cancer than that in patients with early gastric cancer.
- pylori organisms live in gastric mucosa, and attach to epithelial cells of stomach .Because trefoil factor family 3 is not expressed in epithelial cells of the stomach and is only expressed in the intestinal goblet cells of the metaplasia of gastric cancer , serum trefoil factor family 3 levels are less influenced by H. pylori infection , eradication, aging, and sex ,therefore, serum trefoil factor family 3 is a more stable non invasive biomarker of gastric cancer risk even in early gastric cancer.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group:1 | – | Diagnostic Test: Trefoil factor family 3 (TFF3),Pepsinogen 1(PG1)Gastric cancer patients |
| Group:2 | – | Diagnostic Test: Trefoil factor family 3 (TFF3),Pepsinogen 1(PG1)Patients with benign gastric diseases |
Who may qualify
- Ages
- 15 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study will be conducted on 90 informed individuals (according to the guidelines of ethical committee of faculty of Medicine, Assiut University and South Egypt Cancer Institute).
Key inclusion criteria (2 listed)
- Includes all patients presented by gastric cancer with clinical, radiological, laboratory diagnosis and pathological diagnosis.
- Individuals with benign diseases such as gastric polyps ,leiomyomas, gastric ulcers, atrophic gastritis and gastritis clinical, radiological, laboratory and pathological diagnosis.
Key exclusion criteria (3 listed)
- - Previous upper gastrointestinal surgery, patients with gastric cancer that had been received chemotherapy, radiotherapy or surgical treatment.
- Patients simultaneously presented with a malignancy other than that of the stomach (Breast, pancreatic or colorectal).
- Pateints with severe systemic co-morbidities such as cardiopulmonary,hepatic and renal diseases
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 |
|---|---|---|
| Trefoil factor family 3 (TFF3),Pepsinogen 1(PG1)Diagnostic Test: A) CBC . B) FBG. C)KFT. D) LFT. A)CBC: Complete blood count. B)FBG: Fasting blood glucose. C)KFT: Kidney function tests. D)LFT: Liver function tests. | Diagnostic test | Group:1, Group:2 |
Primary outcome
Diagnostic value of trefoil factor family 3 (TFF3) in serum of gastric cancer as non invasive marker
Time frame: 2 day
Measurement of TFF3 by enzyme linked immunosorbent assay (ELISA) in serum of gastric cancer patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2020.
- Background: PubMed 25505714Choi IJ. Endoscopic gastric cancer screening and surveillance in high-risk groups. Clin Endosc. 2014 Nov;47(6):497-503. doi: 10.5946/ce.2014.47.6.497. Epub 2014 Nov 30.
- Background: PubMed 27154568Lee JY, Park KS, Lee HG, Baek WK, Cho KB, Lee YJ, Lee YS, Ryu SW. Comparison of serum trefoil factor 3 with the pepsinogen test for the screening of diffuse-type gastric cancer. Clin Exp Med. 2017 Aug;17(3):403-410. doi: 10.1007/s10238-016-0426-1. Epub 2016 May 6.
- Background: PubMed 26265233Xiao P, Ling H, Lan G, Liu J, Hu H, Yang R. Trefoil factors: Gastrointestinal-specific proteins associated with gastric cancer. Clin Chim Acta. 2015 Oct 23;450:127-34. doi: 10.1016/j.cca.2015.08.004. Epub 2015 Aug 8.
- Individual participant dataSharing planned: Undecided
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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.
Heba Ahmed, MD principal investigator
Assiut University
Ebtesam Farouk, MD study chair
Assiut University
Abeer Ahmed, MD study chair
Assiut University
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 Cancer, 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 2 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 9 Jan 2020. 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?
Contact Melouk Mahmoud, Dr (01061884390, meloukahmed1987@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic value of trefoil factor family 3 (TFF3) in serum of gastric cancer as non invasive marker (time frame: 2 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03894384, which also lists 3 linked publications.
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 9 Jan 2020.