Gastric Cancer Precursor Lesions (GCPL) Study

NCT03188406 | Completed

• 3 other identifiers: NCI-2020-0707017-C-N094999917094
• Study Type: observational
• Target: 1,300
• Locations: 1 country
• Sites: 9

Brief 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. They want to reduce the number of people with stomach cancer. 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.

Conditions

Intestinal Metaplasia; Gastric Cancer

Keywords

Gastric Intestinal Metaplasia; Epidemiology; Risk stratification; Helicobacter pylori; Precancerous lesions; Gastric atrophy

Outcome Measures

Primary Outcomes (1)

• Histological diagnosis

  Advanced intestinal metaplasia

  At enrollment

Study Arms (3)

Gastric cancer

Patients with clinical or histological diagnosis of stomach cancer

Gastric intestinal metaplasia

Patients classified as OLGIM \>0

Non-atrophic gastritis

Patients classified as OLGA 0

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients attending gastroenterology services.

You may qualify if:

• 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.

You may not qualify if:

• Pregnant women
• Children

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (9)

Universidad de Concepción

Concepción, Chile

Location

Hospital de Curanilahue

Curanilahue, Chile

Location

Hospital Intercultural

Nueva Imperial, Chile

Location

Hospital de Puerto Montt

Port Montt, Chile

Location

Hospital San Juan de Dios

Santiago, Chile

Location

Pontificia Universidad Catolica

Santiago, Chile

Location

Hospital de Temuco

Temuco, Chile

Location

Hospital de Victoria

Victoria, Chile

Location

Hospital de Villarrica

Villarrica, Chile

Location

Related Publications (5)

• 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.

  PMID: 1458460 BACKGROUND

• 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.

  PMID: 23280711 BACKGROUND

• 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.

  PMID: 23224270 BACKGROUND

• 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.

  PMID: 20381801 BACKGROUND

• 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.

  PMID: 18424244 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

gastric tissue, serum, plasma, buffy coat, saliva, urine, and stool.

MeSH Terms

Conditions

Stomach Neoplasms; Gastritis, Atrophic

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Gastritis; Gastroenteritis

Study Officials

• M. Constanza Camargo, Ph.D.

  U.S. National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

• Alejandro Corvalan, M.D.

  Pontificia Universidad Catolica (Chile)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2017
• First Posted: June 15, 2017
• Study Start: May 2, 2017
• Primary Completion: April 24, 2020
• Study Completion: April 28, 2020
• Last Updated: December 19, 2020

Record last verified: 2020-12

Locations

CL (9)