Trial · NCT00983580
Acetylsalicylic Acid and Eflornithine in Treating Patients at High Risk for Colorectal Cancer
NCT00983580, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2018-04-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Acetylsalicylic Acid and Eflornithine in Treating Patients at High Risk for Colorectal Cancer. Trials, record NCT00983580. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00983580
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Acetylsalicylic Acid and Eflornithine in Treating Patients at High Risk for Colorectal Cancer
- NCT number
- NCT00983580
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 107 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Adenomatous Polyp
- Interventions
- Aspirin, Eflornithine, Laboratory Biomarker Analysis, Placebo, Telephone-Based Intervention
- First posted
- 2009-09-24
- Last updated
- 2019-09-04
- Results first posted
- 2018-04-30
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Adenoma Recurrence Rate for the Treatment Arm Relative to Placebo | At 1 year | The primary endpoint is the proportion of participants with an adenoma recurrence at the 1-year follow-up colonoscopy exam. All eligible, randomized participants who have signed a consent form and received at least one follow-up endoscopy exam will be considered evaluable for the primary endpoint. This adenoma recurrence rate for DFMO + aspirin will be compared to double placebo to see if there is improvement in the adenoma recurrence rate in this patient population. A 1-sided Chi-square test was used to determine if there was a significant difference between treatment arms. |
| Secondary | ACF Characteristics vs Adenoma Recurrence Rate | At baseline and 1 year | A potential surrogate endpoint biomarker is the aberrant crypt focus (ACF). ACF are the earliest lesions that can be detected in colorectal mucosa and are believed to be precursors of adenomas and cancers. At the 1-year time point, the presence of adenoma recurrence and the number of ACF sites was recorded for each patient. The percent change in ACF number was calculated as the number of ACF present at the 1-year post-intervention exam minus the baseline number of ACF, divided by the number of ACF present at baseline. A negative score represents a loss in the number of sites and a positive number indicates an increase in the number of ACF sites. Therefore, the possible range in percent change cannot be lower than -100% and has no upper bound. A Wilcoxon Rank-sum test was used to assess the relationship between ACF percent change and adenoma recurrence rate. This analysis was only conducted in those participants who had at least 5 rectal ACF at baseline. |
| Secondary | Characterization of ACF | Baseline | A potential surrogate endpoint biomarker is the aberrant crypt focus (ACF). ACF are the earliest lesions that can be detected in colorectal mucosa and are believed to be precursors of adenomas and cancers. The number and total size of ACF sites may serve as risk markers for adenoma/carcinoma development. The median number of ACF sites per patient were collected prior to treatment. |
| Secondary | Comparison of the Percent Change in ACF Number Across the 2 Treatment Arms | At baseline and 12 months | The number of ACF sites per patient was collected at baseline and at 1-year time points. The percent change in ACF number was calculated as the number of ACF present at the 12-month post-intervention exam minus the baseline number of ACF, divided by the number of ACF present at baseline. A negative score represents a loss in the number of sites from baseline to year 1 post-treatment. A positive number indicates an increase in the number of ACF sites. Therefore, the possible range in percent change cannot be lower than -100% and has no upper bound. The percent change in ACF number between arms was compared using a t-test. |
| Secondary | Safety, Tolerability, and Adverse Events of Study Treatment | Up to 48 months from beginning treatment. | The National Cancer Institute (NCI) Common Terminology Criteria (CTC) Version 3.0 was used to grade all adverse events. The number of patients reporting a grade 3 or higher event are tabulated here. A grade 3 event is one categorized as being severe or medically significant but not immediately life-threatening. A grade 4 is considered life-threatening, and a grade 5 is death related to the event. A complete list of all adverse events is given in the Adverse Events section. |
| Other | Effect of the Study Drugs and Placebo With Respect to Biomarkers | Baseline and 12 months | For continuous variables, we will use the 2-sample t-test (or nonparametric equivalent) to compare the active arm to the placebo arm. For categorical data, we will explore the relationship between the treatment arms and biomarkers with chi-square or fisher's exact tests. Correlations will be sought between caspase-3 staining, proliferative indices and their ratio, as well as other biomarkers using a chi-square test. |
| Other | Gene Expression Analysis | Baseline and 12 months | Differences in log-transformed values among ACF or patient characteristics will be compared using t tests or analysis of variance (ANOVAs). |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Adenoma Recurrence Rate for the Treatment Arm Relative to Placebo | At 1 year | On Arm 1, 1 patient cancelled prior to treatment, 1 was a violation, 3 were deemed ineligible, and 7 patients did not receive a follow-up endoscopy. On Arm 2, 3 patients cancelled prior to treatment, 1 was a violation, and 6 did not receive a follow-up endoscopy. | proportion of participants | NUMBER |
| SECONDARY | ACF Characteristics vs Adenoma Recurrence Rate | At baseline and 1 year | All patients that were eligible, treated, analyzed for ACF at baseline and 12-months, and had 5 or more ACF at baseline were included in this analysis. | percentage of change in ACF number | MEDIAN |
| SECONDARY | Characterization of ACF | Baseline | Of the 49 eligible patients receiving treatment in Arm I, 2 patients did not have ACF analysis done. The same number of patients of patients did not have ACF done in Arm II. | number of ACF sites | MEDIAN |
| SECONDARY | Comparison of the Percent Change in ACF Number Across the 2 Treatment Arms | At baseline and 12 months | All eligible treated patients that were assessed for ACF at baseline and after 1-year of treatment were included in this analysis. | percentage of change in ACF number | MEAN |
| SECONDARY | Safety, Tolerability, and Adverse Events of Study Treatment | Up to 48 months from beginning treatment. | On Arm 1, 1 patient cancelled prior to treatment, 1 was a violation, 3 were deemed ineligible. On Arm 2, 3 were ineligible, 1 was a violation. All other patients were treated and evaluated for toxicity and included in this evaluation. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Effect of the Study Drugs and Placebo With Respect to Biomarkers | Baseline and 12 months | Data were not collected for this endpoint. | ||
| OTHER_PRE_SPECIFIED | Gene Expression Analysis | Baseline and 12 months | Data were not collected for this endpoint. |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Adenoma Recurrence Rate for the Treatment Arm Relative to Placebo | Arm I (Acetylsalicylic Acid and Eflornithine) | 0.595 | proportion of participants | ||
| Adenoma Recurrence Rate for the Treatment Arm Relative to Placebo | Arm II (Placebo) | 0.581 | proportion of participants | ||
| ACF Characteristics vs Adenoma Recurrence Rate | All Patients | No Adenoma Recurrence at 12 months | -20.8 | Full Range -89.5 to 237.5 | percentage of change in ACF number |
| ACF Characteristics vs Adenoma Recurrence Rate | All Patients | Adenoma Recurrence at 12 months | -45.0 | Full Range -100 to 300 | percentage of change in ACF number |
| Characterization of ACF | Arm I (Acetylsalicylic Acid and Eflornithine) | 11 | Full Range 0 to 42 | number of ACF sites | |
| Characterization of ACF | Arm II (Placebo) | 7 | Full Range 0 to 31 | number of ACF sites | |
| Comparison of the Percent Change in ACF Number Across the 2 Treatment Arms | Arm I (Acetylsalicylic Acid and Eflornithine) | -28.6 | Standard Deviation 51.1 | percentage of change in ACF number | |
| Comparison of the Percent Change in ACF Number Across the 2 Treatment Arms | Arm II (Placebo) | 10.6 | Standard Deviation 97.4 | percentage of change in ACF number | |
| Safety, Tolerability, and Adverse Events of Study Treatment | Arm I (Acetylsalicylic Acid and Eflornithine) | Grade 3 Adverse Event | 0 | Participants | |
| Safety, Tolerability, and Adverse Events of Study Treatment | Arm II (Placebo) | Grade 3 Adverse Event | 3 | Participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm I (Acetylsalicylic Acid and Eflornithine) | 54 | |
| Overall Study | STARTED | Arm II (Placebo) | 53 | |
| Overall Study | COMPLETED | Arm I (Acetylsalicylic Acid and Eflornithine) | 49 | |
| Overall Study | COMPLETED | Arm II (Placebo) | 49 | |
| Overall Study | NOT COMPLETED | Arm I (Acetylsalicylic Acid and Eflornithine) | 5 | |
| Overall Study | NOT COMPLETED | Arm II (Placebo) | 4 |
Source ClinicalTrials.gov
Adverse events26
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 | Hearing test abnormal | Ear and labyrinth disorders | Arm I (Acetylsalicylic Acid and Eflornithine) | 1 | 52 | 1 |
| other | Hearing test abnormal | Ear and labyrinth disorders | Arm II (Placebo) | 1 | 50 | 1 |
| other | Tinnitus | Ear and labyrinth disorders | Arm I (Acetylsalicylic Acid and Eflornithine) | 2 | 52 | 7 |
| other | Tinnitus | Ear and labyrinth disorders | Arm II (Placebo) | 4 | 50 | 9 |
| other | Abdominal pain | Gastrointestinal disorders | Arm I (Acetylsalicylic Acid and Eflornithine) | 0 | 52 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Arm II (Placebo) | 1 | 50 | 1 |
| other | Diarrhea | Gastrointestinal disorders | Arm I (Acetylsalicylic Acid and Eflornithine) | 0 | 52 | 0 |
| other | Diarrhea | Gastrointestinal disorders | Arm II (Placebo) | 1 | 50 | 1 |
| other | Gastrointestinal disorder | Gastrointestinal disorders | Arm I (Acetylsalicylic Acid and Eflornithine) | 1 | 52 | 1 |
| other | Gastrointestinal disorder | Gastrointestinal disorders | Arm II (Placebo) | 0 | 50 | 0 |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm I (Acetylsalicylic Acid and Eflornithine) | 0 | 52 |
| Total, all-cause mortality | Arm II (Placebo) | 0 | 50 |
| Total, other adverse events | Arm I (Acetylsalicylic Acid and Eflornithine) | 4 | 52 |
| Total, other adverse events | Arm II (Placebo) | 4 | 50 |
| Total, serious adverse events | Arm I (Acetylsalicylic Acid and Eflornithine) | 0 | 52 |
| Total, serious adverse events | Arm II (Placebo) | 1 | 50 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants2
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 | Source |
|---|---|---|---|---|---|---|
| P30CA015083 | Mayo Clinic Comprehensive Cancer Center Support Grant | WILLMAN, CHERYL LYNN | MAYO CLINIC ROCHESTER | NATIONAL CANCER INSTITUTE | 1985 to 2025 | NIH RePORTER |
| R01CA113681 | Aberrant Crypt Foci as a Biomarker for Chemoprevention | SINICROPE, FRANK A. | MAYO CLINIC ROCHESTER | NATIONAL CANCER INSTITUTE | 2006 to 2009 | NIH RePORTER |
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm I (Acetylsalicylic Acid and Eflornithine) vs Arm II (Placebo): deaths from any cause | Trial comparisons |
| Arm I (Acetylsalicylic Acid and Eflornithine) vs Arm II (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/NCT00983580
GET https://conductscience.org/api/trials/v1/NCT00983580/events?page=2