NCT03894384

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 28, 2019

Completed
8 months until next milestone

Study Start

First participant enrolled

December 1, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

January 9, 2020

Status Verified

March 1, 2019

Enrollment Period

1.9 years

First QC Date

March 27, 2019

Last Update Submit

January 6, 2020

Conditions

Gastric Cancer

Keywords

TFF3PG1

Outcome Measures

Primary Outcomes (1)

  • 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

    2 day

Study Arms (2)

Group:1

Gastric cancer patients

Diagnostic Test: Trefoil factor family 3 (TFF3),Pepsinogen 1(PG1)

Group:2

Patients with benign gastric diseases

Diagnostic Test: Trefoil factor family 3 (TFF3),Pepsinogen 1(PG1)

Interventions

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.

Group:1Group:2

Eligibility Criteria

Age15 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

  • 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.

You may not qualify if:

  • \- 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Melouk Ahmed Mahmoud

Asyut, Egypt

RECRUITING

Related Publications (3)

  • 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.

    PMID: 25505714BACKGROUND

  • 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.

    PMID: 27154568BACKGROUND

  • 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.

    PMID: 26265233BACKGROUND

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Heba Ahmed, MD

    Assiut University

    PRINCIPAL INVESTIGATOR

  • Ebtesam Farouk, MD

    Assiut University

    STUDY CHAIR

  • Abeer Ahmed, MD

    Assiut University

    STUDY CHAIR

  • Melouk Ahmed, Dr

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Melouk Mahmoud, Dr

CONTACT

01061884390meloukahmed1987@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

March 27, 2019

First Posted

March 28, 2019

Study Start

December 1, 2019

Primary Completion

November 1, 2021

Study Completion

November 1, 2022

Last Updated

January 9, 2020

Record last verified: 2019-03

Locations

EG(1)