Trial · NCT02794428
Chemoprevention of Gastric Carcinogenesis
NCT02794428, Phase 2, Completed, Vanderbilt-Ingram Cancer Center; results first posted 2024-04-05
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Chemoprevention of Gastric Carcinogenesis. Trials, record NCT02794428. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02794428
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Chemoprevention of Gastric Carcinogenesis
- NCT number
- NCT02794428
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 91 participants, actual
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Conditions
- Gastric Cancer, Gastric Intestinal Metaplasia
- Interventions
- Eflornithine, Eflornithine placebo
- First posted
- 2016-06-09
- Last updated
- 2026-09-02
- Results first posted
- 2024-04-05
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Gastric Epithelial Cell DNA Damage, at 6 Months Versus Baseline | Baseline up to 6 months | The cell DNA damage is measured by the percent positive gastric epithelial cells, as assessed by IHC for gamma H2AX. The mean differences at 6 months versus baseline of the percent positive gastric epithelial cells is compared between the two groups. |
| Secondary | Gastric Epithelial Cell DNA Damage, at 18 Months Versus Baseline | Baseline up to 18 months | The cell DNA damage is measured using the percent positive gastric epithelial cells, as assessed by IHC for gamma H2AX. The mean differences in percent positive gastric epithelial cells at 18 months versus baseline is compared between the two groups. |
| Secondary | Gastric Epithelial Cell DNA Damage, at 24 Months Versus Baseline | Baseline up to 24 months | The cell DNA damage is measured by the percent positive gastric epithelial cells, as assessed by IHC for gamma H2AX. The mean differences at 24 months versus baseline of the percent positive gastric epithelial cells is compared between the two groups. |
| Secondary | Change in Gastric Histopathology Score, at 6 Months Versus Baseline | Baseline up to 6 months | The mean differences in the gastric histopathology score at 6 months versus baseline are calculated, with comparison of the eflornithine and placebo groups. The changes in histology stage are assessed with the validated Correa Histopathology Score system (ranges represent differences in severity and extent): normal mucosa 1, non-atrophic gastritis 2, multifocal atrophic gastritis without intestinal metaplasia 3.25-4.0, gastric intestinal metaplasia 4.3-5.0, dysplasia 5.25-5.75, and cancer 6. The Correa Histopathology Score is based upon the Updated Sydney System biopsy protocol (5 biopsies). The most advanced lesion (highest Correa score) in the stomach represents the summary Correa score for the patient at the given time point. |
| Secondary | Change in Gastric Histology Score, at 18 Months Versus Baseline | Baseline up to 18 months | The mean differences in the gastric histopathology score at 18 months versus baseline are calculated, with comparison of the eflornithine and placebo groups. The changes in histology stage are assessed with the validated Correa Histopathology Score system (ranges represent differences in severity and extent): normal mucosa 1, non-atrophic gastritis 2, multifocal atrophic gastritis without intestinal metaplasia 3.25-4.0, gastric intestinal metaplasia 4.3-5.0, dysplasia 5.25-5.75, and cancer 6. The Correa Histopathology Score is based upon the Updated Sydney System biopsy protocol (5 biopsies). The most advanced lesion (highest Correa score) in the stomach represents the summary Correa score for the patient at the given time point. |
| Secondary | Change in Gastric Histology Score, at 24 Months Versus Baseline | Baseline up to 24 months | The mean differences in the gastric histopathology score at 24 months versus baseline are calculated, with comparison of the eflornithine and placebo groups. The changes in histology stage are assessed with the validated Correa Histopathology Score system (ranges represent differences in severity and extent): normal mucosa 1, non-atrophic gastritis 2, multifocal atrophic gastritis without intestinal metaplasia 3.25-4.0, gastric intestinal metaplasia 4.3-5.0, dysplasia 5.25-5.75, and cancer 6. The Correa Histopathology Score is based upon the Updated Sydney System biopsy protocol (5 biopsies). The most advanced lesion (highest Correa score) in the stomach represents the summary Correa score for the patient at the given time point. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Difference in Cell DNA Damage, Based on Percent Positive Cells, Between Patients Treated With DFMO and Patients Treated With Placebo at 6 Months. | at 6 months | Percentage of positive cells | MEAN | |
| SECONDARY | 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. | at 18 and 24 months | |||
| SECONDARY | 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. | at 6, 18 and 24 months | |||
| SECONDARY | Number of Patients With Quantitative Toxicities. | at 6, 18, and 24 months |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Difference in Cell DNA Damage, Based on Percent Positive Cells, Between Patients Treated With DFMO and Patients Treated With Placebo at 6 Months. | Eflornithine | 5.07 | Standard Deviation 21.05 | Percentage of positive cells | |
| The Difference in Cell DNA Damage, Based on Percent Positive Cells, Between Patients Treated With DFMO and Patients Treated With Placebo at 6 Months. | Eflornithine Placebo | 7.32 | Standard Deviation 21.60 | Percentage of positive cells |
Source ClinicalTrials.gov
Participant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| 6 Months (Primary End Point) | STARTED | Eflornithine | 45 | |
| 6 Months (Primary End Point) | STARTED | Eflornithine Placebo | 46 | |
| 6 Months (Primary End Point) | COMPLETED | Eflornithine | 36 | |
| 6 Months (Primary End Point) | COMPLETED | Eflornithine Placebo | 42 | |
| 6 Months (Primary End Point) | NOT COMPLETED | Eflornithine | 9 | |
| 6 Months (Primary End Point) | NOT COMPLETED | Eflornithine Placebo | 4 | |
| 18 Months (Secondary Endpoint) | STARTED | Eflornithine | 36 | |
| 18 Months (Secondary Endpoint) | STARTED | Eflornithine Placebo | 42 | |
| 18 Months (Secondary Endpoint) | COMPLETED | Eflornithine | 31 | |
| 18 Months (Secondary Endpoint) | COMPLETED | Eflornithine Placebo | 38 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events10
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhea | Gastrointestinal disorders | Eflornithine | 2 | 45 | 2 |
| other | Diarrhea | Gastrointestinal disorders | Eflornithine Placebo | 3 | 46 | 3 |
| serious | Hypertensive urgency | Cardiac disorders | Eflornithine | 0 | 45 | 0 |
| serious | Hypertensive urgency | Cardiac disorders | Eflornithine Placebo | 1 | 46 | 1 |
| serious | Appendicitis | Gastrointestinal disorders | Eflornithine | 0 | 45 | 0 |
| serious | Appendicitis | Gastrointestinal disorders | Eflornithine Placebo | 1 | 46 | 1 |
| serious | COVID-19 | Infections and infestations | Eflornithine | 1 | 45 | 1 |
| serious | COVID-19 | Infections and infestations | Eflornithine Placebo | 0 | 46 | 0 |
| serious | Diverticulitis | Gastrointestinal disorders | Eflornithine | 1 | 45 | 1 |
| serious | Diverticulitis | Gastrointestinal disorders | Eflornithine Placebo | 0 | 46 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Eflornithine | 0 | 45 |
| Total, all-cause mortality | Eflornithine Placebo | 0 | 46 |
| Total, other adverse events | Eflornithine | 2 | 45 |
| Total, other adverse events | Eflornithine Placebo | 3 | 46 |
| Total, serious adverse events | Eflornithine | 2 | 45 |
| Total, serious adverse events | Eflornithine Placebo | 2 | 46 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41801147 | RESULT |
Source PubMed
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01CA190612 | Targeted chemoprevention of gastric carcinogenesis in high risk populations | WILSON, KEITH T.; MORGAN, DOUGLAS | VANDERBILT UNIVERSITY MEDICAL CENTER | NATIONAL CANCER INSTITUTE | 2014 to 2018 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Eflornithine vs Eflornithine Placebo: deaths from any cause | Trial comparisons |
| Eflornithine vs Eflornithine Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02794428
GET https://conductscience.org/api/trials/v1/NCT02794428/registered