Chemoprevention of Gastric Carcinogenesis
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|ClinicalTrials.gov Identifier: NCT02794428|
Recruitment Status : Recruiting
First Posted : June 9, 2016
Last Update Posted : September 10, 2019
|Condition or disease||Intervention/treatment||Phase|
|Gastric Cancer Gastric Intestinal Metaplasia||Drug: Eflornithine Other: Eflornithine placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Targeted Chemoprevention of Gastric Carcinogenesis in High Risk Populations|
|Actual Study Start Date :||September 19, 2016|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||December 30, 2021|
|Active Comparator: Eflornithine||
Eflornithine*, 2 tablets, Oral, Daily for 18 months
|Placebo Comparator: Eflornithine Placebo||
Other: Eflornithine placebo
Eflornithine placebo, 2 tablets, Oral, Daily for 18 months
- The difference in cell DNA damage between patients treated with DFMO and patients treated with placebo at 6 months. [ Time Frame: at 6 months ]The cell DNA damage is measured using the percent positive cells assessed by quantitative 8-OHdG immunohistochemistry (IHC). The mean difference between the two groups at 6 months will be calculated, accounting for their baseline measurements.
- The difference in cell DNA damage between patients treated with DFMO and patients treated with placebo for 18 months, and then followed for an additional 6 months. [ Time Frame: at 18 and 24 months ]The cell DNA damage is measured using the percent positive cells assessed by quantitative 8-OHdG immunohistochemistry (IHC). The mean difference between the two groups at 18 and 24 months will be calculated, accounting for their baseline measurements.The additional measure of DNA damage (gamma H2AX by IHC and by flow cytometry will also be assessed at 0, 6, 18, and 24 months).
- The differences in the gastritis histopathology score between patients treated with DFMO and patients treated with placebo for a total of 18 months, and followed for an additional 6 months. [ Time Frame: at 6, 18 and 24 months ]The gastritis histopathology score is measured with a quantitative scale 0.0-6.0, for atrophy, intestinal metaplasia, and dysplasia. The mean differences between the two groups at 6, 18, and 24 months will be calculated using mixed models, accounting for their baseline measurements.
- Number of patients with quantitative toxicities. [ Time Frame: at 6, 18, and 24 months ]Toxicities will be assessed per CTCAE criteria, and each toxicity will be assigned an adverse event (AE) term according to CTCAE definitions (each AE term = unique representation of a specific event used for medical documentation and scientific analyses), and graded as defined by CTCAE (grade 1 = mild; grade 2 = moderate; grade 3 = severe or significant but not immediately life-threatening; grade 4 = life-threatening; grade 5 = death).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02794428
|Contact: VICC Clinical Trials Officefirstname.lastname@example.org|
|Ministry of Health, Hospital de Occidente||Recruiting|
|Principal Investigator: Ricardo Dominguez, MD|
|University of Puerto Rico, Comprehensive Cancer Center||Recruiting|
|San Juan, Puerto Rico|
|Contact: MD, PhD|
|Principal Investigator: Marcia Cruz Correa, MD, PhD|
|Study Chair:||Doug Morgan, MD||Vanderbilt University Medical Center, Vanderbilt-Ingram Cancer enter|
|Principal Investigator:||Keith Wilson, MD||Vanderbilt University Medical Center, Vanderbilt-Ingram Cancer enter|