Gastric Cancer Clinical Trial
Official title:
Gastric Cancer Precursor Lesions (GCPL) Study
Verified date | December 2020 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 1300 |
Est. completion date | April 28, 2020 |
Est. primary completion date | April 24, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 70 Years |
Eligibility | - INCLUSION CRITERIA: 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. EXCLUSION CRITERIA: - Pregnant women - Children |
Country | Name | City | State |
---|---|---|---|
Chile | Universidad de Concepción | Concepción | |
Chile | Hospital de Curanilahue | Curanilahue | |
Chile | Hospital Intercultural | Nueva Imperial | |
Chile | Hospital de Puerto Montt | Puerto Montt | |
Chile | Hospital San Juan de Dios | Santiago | |
Chile | Pontificia Universidad Catolica | Santiago | |
Chile | Hospital de Temuco | Temuco | |
Chile | Hospital de Victoria | Victoria | |
Chile | Hospital de Villarrica | Villarrica |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
Chile,
Bonequi P, Meneses-González 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. — View Citation
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. — View Citation
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. Review. — View Citation
González 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. Review. — View Citation
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. Review. — View Citation
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---|---|---|---|---|
Primary | Histological diagnosis | Advanced intestinal metaplasia | At enrollment |
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