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Intestinal MetaplasiaNCT03188406

Gastric Cancer Precursor Lesions (GCPL) Study

An observational study of Intestinal Metaplasia and Gastric Cancer, run by National Cancer Institute (NCI) at 9 sites in Chile.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Background: Gastric cancer is a leading cause of cancer deaths around the world. This disease is a serious problem in places like East Asia, Central and South America, and Eastern Europe. Researchers want to study the causes of gastric cancer and its precursors. Read more about this study

Who is it for?
Ages 40 to 70 years
Conditions the study is for
Intestinal Metaplasia, Gastric Cancer
How many people
1,300 participants
Where
9 sitesChile
Study dates
2 May 2017to 28 Apr 2020
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 40 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients attending gastroenterology services.

Who may be able to join

  • Two groups of symptomatic patients aged 40 to 70 years old, who are long term residents of a high gastric cancer risk area:
  • Approximately 1300 patients who need upper endoscopy (examination of the lining of the stomach with a flexible tube).
  • Approximately 100 patients recently diagnosed with stomach cancer who need surgery as treatment for the disease.

Who cannot join

  • Pregnant women
  • Children

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

Chile9 sites

  • Universidad de Concepción

    Concepción

  • Hospital de Curanilahue

    Curanilahue

  • Hospital Intercultural

    Nueva Imperial

  • Hospital de Puerto Montt

    Port Montt

  • Hospital San Juan de Dios

    Santiago

  • Pontificia Universidad Catolica

    Santiago

  • Hospital de Temuco

    Temuco

  • Hospital de Victoria

    Victoria

  • Hospital de Villarrica

    Villarrica

Other trials in Chile

About this study

Background:

Gastric cancer is a leading cause of cancer deaths around the world. This disease is a serious problem in places like East Asia, Central and South America, and Eastern Europe. Researchers want to study the causes of gastric cancer and its precursors. They want to reduce the number of people with stomach cancer.

Read more

Objectives:

To learn more about bacteria factors and other causes of gastric cancer. To study potential markers associated with precancerous gastric lesions (intestinal metaplasia).

Eligibility:

Adults ages 40-70 years at certain hospitals in Chile who:

Are going to have upper gastrointestinal endoscopies

OR have stomach cancer and need surgery

Design:

Participants will give gastric tissue samples.

Some participants will donate a portion of the stomach tissue that is removed as part of their clinical care.

Participants will give access to reports of their stomach exam. They will allow researchers to photograph the microscope slides of their tissue samples.

Participants will answer questions. The topics of the questions include:

Age, height, weight

Education

Habits including tobacco and alcohol

Personal and family history of disease

Reproductive history

Diet

Some participants will give blood, urine, saliva, and stool samples. Study staff will collect the blood. They will tell the participants how to collect the other samples themselves.

Read the detailed description

The burden of gastric adenocarcinoma is unevenly distributed, with several Asian and Latin American countries having particularly high incidence rates. Although chronic infection with Helicobacter pylori is the primary cause of this cancer, environmental and host cofactors modify the course of infection and determine whether infected individuals develop cancer. Due to the lack of adequate screening strategies and consequent late diagnosis, trends in mortality are similar to incidence, making this neoplasia the third leading cause of cancer death worldwide. The International Agency for Research on Cancer predicts that there will be no reduction in gastric cancer cases until at least 2030 due to population growth and aging. H. pylori-related gastric carcinogenesis is a multi-step process and mucosal lesions of intestinal metaplasia (IM) and dysplasia confer increased risk of progression. Therefore, case-control studies of these premalignant lesions may provide insights into cancer etiology and inform risk stratification. In addition, biomarkers to identify high-risk individuals are needed for early detection and curative treatment. Accordingly, we propose a 3-year study of Chilean adults undergoing upper gastrointestinal endoscopy for clinical purposes to identify 600 subjects with advanced premalignant lesions (i.e., incomplete-type IM, complete-type IM with extension to gastric corpus and dysplasia) for informative comparisons with 600 controls with non-atrophic gastritis, a benign histologic change apparent in most H. pylori infected individuals. As an additional case group, 100 individuals with newly diagnosed gastric cancer will be recruited from the same clinics. This multidisciplinary project will simultaneously evaluate bacterial, host and environmental factors towards a better understanding of gastric cancer etiology that may guide future efforts for prevention and control. We will explore risk factors that have been insufficiently studied, such as various hormones, H. pylori genomics, non- H. pylori gastric microbiota, and other parasitic infections. We will also evaluate potential noninvasive screening markers, including pepsinogens, hormones, miRNAs and DNA methylation. Results from this study may lead to improved management recommendations for individuals with advanced IM. Additionally, the resulting biobank of gastric tissue, blood, urine, saliva and stool will enable state-of-the-art molecular assays and serve as a resource for future research in this area.

Keywords
Gastric Intestinal Metaplasia, Epidemiology, Risk stratification, Helicobacter pylori, Precancerous lesions, Gastric atrophy
Medical subject headings
Stomach Neoplasms, Gastritis, Atrophic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03188406
Study groupRoleWhat they receive
Gastric cancerPatients with clinical or histological diagnosis of stomach cancer
Gastric intestinal metaplasiaPatients classified as OLGIM >0
Non-atrophic gastritisPatients classified as OLGA 0

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Histological diagnosis

    Advanced intestinal metaplasia

    Measured: At enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2017
  2. Study start2 May 2017
  3. Primary completion24 Apr 2020
  4. Study completion28 Apr 2020

Resources

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
Cross-sectional
Enrolment
1,300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03188406
Sponsor's protocol ID
NCI-2020-07070
Other IDs
17-C-N094, 999917094
Status last verified
Dec 2020
First submitted
14 Jun 2017
Last updated
19 Dec 2020
Results posted
No

Publications

  • Correa P. Human gastric carcinogenesis: a multistep and multifactorial process--First American Cancer Society Award Lecture on Cancer Epidemiology and Prevention. Cancer Res. 1992 Dec 15;52(24):6735-40.

    PubMed 1458460

  • Gonzalez CA, Sanz-Anquela JM, Gisbert JP, Correa P. Utility of subtyping intestinal metaplasia as marker of gastric cancer risk. A review of the evidence. Int J Cancer. 2013 Sep 1;133(5):1023-32. doi: 10.1002/ijc.28003. Epub 2013 Feb 5.

    PubMed 23280711

  • Bonequi P, Meneses-Gonzalez F, Correa P, Rabkin CS, Camargo MC. Risk factors for gastric cancer in Latin America: a meta-analysis. Cancer Causes Control. 2013 Feb;24(2):217-31. doi: 10.1007/s10552-012-0110-z. Epub 2012 Dec 7.

    PubMed 23224270

  • Capelle LG, de Vries AC, Haringsma J, Ter Borg F, de Vries RA, Bruno MJ, van Dekken H, Meijer J, van Grieken NC, Kuipers EJ. The staging of gastritis with the OLGA system by using intestinal metaplasia as an accurate alternative for atrophic gastritis. Gastrointest Endosc. 2010 Jun;71(7):1150-8. doi: 10.1016/j.gie.2009.12.029. Epub 2010 Apr 9.

    PubMed 20381801

  • Rugge M, Correa P, Di Mario F, El-Omar E, Fiocca R, Geboes K, Genta RM, Graham DY, Hattori T, Malfertheiner P, Nakajima S, Sipponen P, Sung J, Weinstein W, Vieth M. OLGA staging for gastritis: a tutorial. Dig Liver Dis. 2008 Aug;40(8):650-8. doi: 10.1016/j.dld.2008.02.030.

    PubMed 18424244

Questions about this trial

What is this clinical trial studying?

An observational study of Intestinal Metaplasia and Gastric Cancer, run by National Cancer Institute (NCI) at 9 sites in Chile.

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 3 inclusion and 2 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: finished, as of the sponsor's last update on 19 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Chile. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Histological diagnosis (time frame: At enrollment). 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 NCT03188406, which also lists 5 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 19 Dec 2020; AzTrials last refreshed its copy on 29 Oct 2026.

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