The Value of TFF3 in Diagnosis of Gastric Cancer

January 6, 2020 updated by: Melouk Ahmed, Assiut University

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group:1
Gastric cancer patients
Diagnostic test: 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.
Group:2
Patients with benign gastric diseases
Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Principal Investigator: Heba Ahmed, MD, Assiut University
  • Study Chair: Ebtesam Farouk, MD, Assiut University
  • Study Chair: Abeer Ahmed, MD, Assiut University
  • Study Director: Melouk Ahmed, Dr, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2019

Primary Completion (Anticipated)

November 1, 2021

Study Completion (Anticipated)

November 1, 2022

Study Registration Dates

First Submitted

March 27, 2019

First Submitted That Met QC Criteria

March 27, 2019

First Posted (Actual)

March 28, 2019

Study Record Updates

Last Update Posted (Actual)

January 9, 2020

Last Update Submitted That Met QC Criteria

January 6, 2020

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TFF3 in gastric cancer

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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