Clinical trial NCT03894384: The Value of TFF3 in Diagnosis of Gastric Cancer
Official title: The Value of Serum Trefoil Factor Family 3 (TFF3) in Diagnosis of Gastric Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastric Cancer
Keywords: TFF3
PG1
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-03-28
Enrollment: 90
Sex: ALL
Minimum age (years): 15
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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).

Brief 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.

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.

H. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* - 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

Primary outcomes:
measure: Diagnostic value of trefoil factor family 3 (TFF3) in serum of gastric cancer as non invasive marker
timeFrame: 2 day
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Melouk Ahmed Mahmoud
Study officials:
affiliation: Assiut University
name: Heba Ahmed, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assiut University
name: Ebtesam Farouk, MD
role: STUDY_CHAIR
affiliation: Assiut University
name: Abeer Ahmed, MD
role: STUDY_CHAIR
affiliation: Assiut University
name: Melouk Ahmed, Dr
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Lee 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.
citation: Xiao 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.