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Clinical Trials/NCT03894384
NCT03894384UnknownNot Applicable

The Value of Serum Trefoil Factor Family 3 (TFF3) in Diagnosis of Gastric Cancer

Assiut University1 site in 1 country90 target enrollmentStarted: December 1, 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
90
Locations
1
Primary Endpoint
Diagnostic value of trefoil factor family 3 (TFF3) in serum of gastric cancer as non invasive marker

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Retrospective

Eligibility Criteria

Ages
15 Years to 75 Years (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Melouk Ahmed

Director

Assiut University

Study Sites (1)

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