Colorectal AdenomaPhase 2NCT02965703
Aspirin in Preventing Colorectal Cancer in Patients With Colorectal Adenoma
A Phase 2 study testing Aspirin, Biospecimen Collection and Questionnaire Administration in people with Colorectal Adenoma and Colorectal Carcinoma, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
This phase IIa trial studies how well aspirin works in preventing colorectal cancer in patients with colorectal adenoma. Aspirin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Adenoma, Colorectal Carcinoma
- What is being tested?
- Aspirin, Biospecimen Collection and Questionnaire Administration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jan 2018to 24 Dec 2026
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of colorectal adenoma of any grade
- Age >= 18 years. Because no dosing or adverse event (AE) data are currently available on the use of aspirin in participants < 18 years of age, children are excluded from this study but will be eligible for future pediatric trials, if applicable
- Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%)
- Leukocytes >= 3,000/microliter
- Absolute neutrophil count >= 1,500/microliter
- Platelets >= 150,000/microliter
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- Total bilirubin =< 1.5 x institutional upper limit of normal (ULN)
- Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 1.5 x institutional ULN
- Creatinine =< 1.5 x institutional ULN
- Blood hemoglobin >= 12.0 g/dL
- Alkaline phosphatase =< 1.5 x institutional ULN
- Blood urea nitrogen (BUN) =< 40 mg/dL
- Estimated glomerular filtration rate (eGFR) >= 45 mL/min
- Negative fecal occult blood test
- The effects of aspirin on the developing human fetus at the recommended therapeutic dose are unknown; for this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately
- Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Current (within three weeks of randomization) or planned use during the study intervention of the following:
- Aspirin, other nonsteroidal anti-inflammatory drugs (NSAIDs), or COX-2 inhibitors
- Anticoagulants, anti-platelet agents, or corticosteroids
- Gingko
- Ethanol consumption > 1 standard drinks/day for women, or > 2 standard drinks/day for men
- Methotrexate (MTX)
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- Study participants will be instructed to use Tylenol or some other non-excluded agent to treat common ailments (i.e. headache/minor aches and pains)
- History of
- Any invasive malignancy within the past 2 years, with the exception of non-melanoma skin cancer
- Chronic renal diseases or liver cirrhosis
- Diseases such as anemia, peptic ulcer, gastrointestinal bleeding, active colitis and inflammatory bowel disease
- Hemorrhagic stroke or uncontrolled hypertension
- Participants may not be receiving any other investigational agents
- History of allergic reactions or intolerance attributed to aspirin or compounds of similar chemical or biologic composition
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness that would limit compliance with study requirements
- Women who are pregnant or breastfeeding; pregnant women are excluded from this study because aspirin has the potential for abortifacient effects; because there is an unknown but potential risk for adverse events (AEs) in nursing infants secondary to treatment of the mother with aspirin, breastfeeding should be discontinued if the mother is treated with aspirin
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232
About this study
Official title: Evaluating Intermittent Dosing of Aspirin for Colorectal Cancer Chemoprevention
This phase IIa trial studies how well aspirin works in preventing colorectal cancer in patients with colorectal adenoma. Aspirin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Read the detailed description
PRIMARY OBJECTIVE:
- To test for the equivalency of the two aspirin schedules.
SECONDARY OBJECTIVES:
- To evaluate the effects of aspirin treatments on:
Ia. The ratio of cell proliferation (Ki-67)/apoptosis (TUNEL) in rectal biopsies; Ib. The ratio of cell proliferation (Ki-67)/necroptosis (pMLKL) in rectal biopsies; Ic. Fecal occult blood test (measures of adverse events) as measured by stool samples.
EXPLORATORY OBJECTIVES:
- To evaluate the effects of aspirin treatments on:
Ia. Cyclooxygenase-2 (COX-2) in rectal biopsies; Ib. Bcl-2-like protein 4 (BAX) in rectal biopsies; Ic. Transient receptor potential cation channel subfamily M member (7TRPM7) in rectal biopsies; Id. Joint index of COX-2 with TRPM7 expression in rectal biopsies; Ie. Joint index of TRPM7 with BAX in rectal biopsies; If. Methylation assays using the MethylationEPIC BeadChip to identify methylation biomarkers in genes (i.e. CDKN2A [cell cycle regulation], MGMT [deoxyribonucleic acid (DNA) repair], DAPK1 [apoptosis], CDH1 [cell invasion], WNT16 [Wnt pathway] and RASSF1 [RAS signaling]) involved in colorectal carcinogenesis, and other epigenome-wide methylation biomarkers as measured in rectal biopsies; Ig. Metagenomics analysis to measure abundance of Escherichia coli (E. coli) and Fusobacterium and other microbiota in rectal swabs.
OUTLINE: Patients are randomized to 1 of 3 arms.
ARM I: Patients receive aspirin orally (PO) daily for 12 weeks in the absence of unacceptable toxicity. Patients also undergo collection of blood, urine, stool, rectal swab samples, and rectal biopsies throughout the trial.
ARM II: Patients receive aspirin PO daily at weeks 1-3 and 7-9 and placebo PO daily at weeks 4-6 and 10-12 in the absence of unacceptable toxicity. Patients also undergo collection of blood, urine, stool, rectal swab samples, and rectal biopsies throughout the trial.
ARM III: Patients receive placebo PO daily for 12 weeks in the absence of unacceptable toxicity. Patients also undergo collection of blood, urine, stool, rectal swab samples, and rectal biopsies throughout the trial.
After completion of study, patients are followed up at 1 month.
- Conditions
- Colorectal Adenoma, Colorectal Carcinoma
- Being tested
- Aspirin, Biospecimen Collection, Placebo Administration, Questionnaire Administration, Rectal Biopsy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AspirinDrug
Also called Acetylsalicylic Acid, ASA, Aspergum, Ecotrin
Given PO
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection
Undergo collection of blood, urine, stool, and rectal swab samples
Placebo AdministrationOther
Given PO
Questionnaire AdministrationOther
Ancillary studies
Rectal BiopsyProcedure or surgery
Also called Biopsy of Rectum
Undergo rectal biopsy
| Study group | Role | What they receive |
|---|---|---|
| Arm I (aspirin) | Experimental | Patients receive aspirin PO daily for 12 weeks in the absence of unacceptable toxicity. Patients also undergo collection of blood, urine, stool, rectal swab samples, and rectal biopsies throughout the trial. Receives: Drug: Aspirin; Procedure: Biospecimen Collection; Other: Questionnaire Administration; Procedure: Rectal Biopsy |
| Arm II (aspirin, placebo) | Experimental | Patients receive aspirin PO daily at weeks 1-3 and 7-9 and placebo PO daily at weeks 4-6 and 10-12 in the absence of unacceptable toxicity. Patients also undergo collection of blood, urine, stool, rectal swab samples, and rectal biopsies throughout the trial. Receives: Drug: Aspirin; Procedure: Biospecimen Collection; Other: Placebo Administration; Other: Questionnaire Administration; Procedure: Rectal Biopsy |
| Arm III (placebo) | Placebo comparator | Patients receive placebo PO daily for 12 weeks in the absence of unacceptable toxicity. Patients also undergo collection of blood, urine, stool, rectal swab samples, and rectal biopsies throughout the trial. Receives: Procedure: Biospecimen Collection; Other: Placebo Administration; Other: Questionnaire Administration; Procedure: Rectal Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio of Cell Proliferation to Apoptosis Biomarkers (Ki67 Index and BAX Index)
Change in the ratio of proliferation to apoptosis biomarkers (Ki67 density index: BAX density index, measured continuously after IHC staining) in colorectal mucosa of compliant participants
Measured: Baseline to end of intervention up to 12 weeks
Secondary outcomes (3)
Ratio of Cell Proliferation (Ki-67)/Apoptosis (TdT-mediated dUTP Nick End Labeling [TUNEL]) in Rectal Biopsies
Change in the ratio of proliferation to apoptosis biomarkers (Ki67 density index: TUNEL density index, measured continuously after IHC staining) in colorectal mucosa of compliant participants.
Measured: Baseline to end of intervention up to 12 weeks
Ratio of Cell Proliferation (Ki-67)/Necroptosis (MLKL) in Rectal Biopsies
Change in the ratio of proliferation to necroptosis biomarkers (Ki67 density index: pMLKLdensity index, measured continuously after IHC staining) in colorectal mucosa of compliant participants
Measured: Baseline to end of intervention up to 12 weeks
Fecal Occult Blood Test (Measures of Adverse Events) as Measured by Stool Samples
The number of participants who started intervention and had a positive fecal occult blood test result
Measured: Baseline to end of intervention up to 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2016 (estimated)
- Study start16 Jan 2018
- Primary completion31 Jan 2023
- Study completion24 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal AdenomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Qi Dai, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02965703
- Sponsor's protocol ID
- NCI-2016-01642
- Other IDs
- NCI-2016-01642, N01-CN-2012-00035, NCI2015-06-01, NWU2015-06-01, N01CN00035, P30CA060553
- Status last verified
- Aug 2026
- First submitted
- 16 Nov 2016
- Last updated
- 6 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Zhu X, Chen R, Ness RM, Naik RD, Murff HJ, Zhang H, Xu Y, Benante KA, Azcarate-Peril MA, Zheng Y, Wang J, Shrubsole MJ, Su T, Mi X, Kocherginsky M, Rodriguez LM, Della'Zanna G, Richmond E, Hou L, Khan SA, Dai Q. Evaluating Intermittent Dosing of Aspirin for Colorectal Cancer Chemoprevention. Cancer Prev Res (Phila). 2025 Jun 2;18(6):321-334. doi: 10.1158/1940-6207.CAPR-24-0168.
PubMed 40034042
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Intermittent Dosing of Aspirin for Colorectal Cancer Chemoprevention
- ClinicalTrials.gov ID
- NCT02965703
- Acronym / sponsor ID
- NCI-2016-01642
- Conditions
- Colorectal Adenoma, Colorectal Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 81 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 16 Jan 2018 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 24 Dec 2026 (estimated)
- First posted
- 17 Nov 2016 (estimated)
- Results
- Posted 4 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase IIa trial studies how well aspirin works in preventing colorectal cancer in patients with colorectal adenoma. Aspirin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Detailed description
PRIMARY OBJECTIVE:
- To test for the equivalency of the two aspirin schedules.
SECONDARY OBJECTIVES:
- To evaluate the effects of aspirin treatments on:
Ia. The ratio of cell proliferation (Ki-67)/apoptosis (TUNEL) in rectal biopsies; Ib. The ratio of cell proliferation (Ki-67)/necroptosis (pMLKL) in rectal biopsies; Ic. Fecal occult blood test (measures of adverse events) as measured by stool samples.
EXPLORATORY OBJECTIVES:
- To evaluate the effects of aspirin treatments on:
Ia. Cyclooxygenase-2 (COX-2) in rectal biopsies; Ib. Bcl-2-like protein 4 (BAX) in rectal biopsies; Ic. Transient receptor potential cation channel subfamily M member (7TRPM7) in rectal biopsies; Id. Joint index of COX-2 with TRPM7 expression in rectal biopsies; Ie. Joint index of TRPM7 with BAX in rectal biopsies; If. Methylation assays using the MethylationEPIC BeadChip to identify methylation biomarkers in genes (i.e. CDKN2A [cell cycle regulation], MGMT [deoxyribonucleic acid (DNA) repair], DAPK1 [apoptosis], CDH1 [cell invasion], WNT16 [Wnt pathway] and RASSF1 [RAS signaling]) involved in colorectal carcinogenesis, and other epigenome-wide methylation biomarkers as measured in rectal biopsies; Ig. Metagenomics analysis to measure abundance of Escherichia coli (E. coli) and Fusobacterium and other microbiota in rectal swabs.
OUTLINE: Patients are randomized to 1 of 3 arms.
ARM I: Patients receive aspirin orally (PO) daily for 12 weeks in the absence of unacceptable toxicity. Patients also undergo collection of blood, urine, stool, rectal swab samples, and rectal biopsies throughout the trial.
ARM II: Patients receive aspirin PO daily at weeks 1-3 and 7-9 and placebo PO daily at weeks 4-6 and 10-12 in the absence of unacceptable toxicity. Patients also undergo collection of blood, urine, stool, rectal swab samples, and rectal biopsies throughout the trial.
ARM III: Patients receive placebo PO daily for 12 weeks in the absence of unacceptable toxicity. Patients also undergo collection of blood, urine, stool, rectal swab samples, and rectal biopsies throughout the trial.
After completion of study, patients are followed up at 1 month.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm I (aspirin) | Experimental | Drug: Aspirin, Procedure: Biospecimen Collection, Other: Questionnaire Administration, Procedure: Rectal BiopsyPatients receive aspirin PO daily for 12 weeks in the absence of unacceptable toxicity. Patients also undergo collection of blood, urine, stool, rectal swab samples, and rectal biopsies throughout the trial. |
| Arm II (aspirin, placebo) | Experimental | Drug: Aspirin, Procedure: Biospecimen Collection, Other: Placebo Administration, Other: Questionnaire Administration, Procedure: Rectal BiopsyPatients receive aspirin PO daily at weeks 1-3 and 7-9 and placebo PO daily at weeks 4-6 and 10-12 in the absence of unacceptable toxicity. Patients also undergo collection of blood, urine, stool, rectal swab samples, and rectal biopsies throughout the trial. |
| Arm III (placebo) | Placebo comparator | Procedure: Biospecimen Collection, Other: Placebo Administration, Other: Questionnaire Administration, Procedure: Rectal BiopsyPatients receive placebo PO daily for 12 weeks in the absence of unacceptable toxicity. Patients also undergo collection of blood, urine, stool, rectal swab samples, and rectal biopsies throughout the trial. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Diagnosis of colorectal adenoma of any grade
- Age >= 18 years. Because no dosing or adverse event (AE) data are currently available on the use of aspirin in participants < 18 years of age, children are excluded from this study but will be eligible for future pediatric trials, if applicable
- Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%)
- Leukocytes >= 3,000/microliter
- Absolute neutrophil count >= 1,500/microliter
Key exclusion criteria (16 listed)
- Current (within three weeks of randomization) or planned use during the study intervention of the following:
- History of
- Participants may not be receiving any other investigational agents
- History of allergic reactions or intolerance attributed to aspirin or compounds of similar chemical or biologic composition
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness that would limit compliance with study requirements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AspirinAlso: Acetylsalicylic Acid, ASA, Aspergum, EcotrinGiven PO | Drug | Arm I (aspirin), Arm II (aspirin, placebo) |
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen CollectionUndergo collection of blood, urine, stool, and rectal swab samples | Procedure or surgery | Arm I (aspirin), Arm II (aspirin, placebo), Arm III (placebo) |
| Placebo AdministrationGiven PO | Other | Arm II (aspirin, placebo), Arm III (placebo) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (aspirin), Arm II (aspirin, placebo), Arm III (placebo) |
| Rectal BiopsyAlso: Biopsy of RectumUndergo rectal biopsy | Procedure or surgery | Arm I (aspirin), Arm II (aspirin, placebo), Arm III (placebo) |
Primary outcome
Ratio of Cell Proliferation to Apoptosis Biomarkers (Ki67 Index and BAX Index)
Time frame: Baseline to end of intervention up to 12 weeks
Change in the ratio of proliferation to apoptosis biomarkers (Ki67 density index: BAX density index, measured continuously after IHC staining) in colorectal mucosa of compliant participants
3 secondary outcomes
Ratio of Cell Proliferation (Ki-67)/Apoptosis (TdT-mediated dUTP Nick End Labeling [TUNEL]) in Rectal Biopsies
Time frame: Baseline to end of intervention up to 12 weeks
Ratio of Cell Proliferation (Ki-67)/Necroptosis (MLKL) in Rectal Biopsies
Time frame: Baseline to end of intervention up to 12 weeks
Fecal Occult Blood Test (Measures of Adverse Events) as Measured by Stool Samples
Time frame: Baseline to end of intervention up to 12 weeks.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40034042Zhu X, Chen R, Ness RM, Naik RD, Murff HJ, Zhang H, Xu Y, Benante KA, Azcarate-Peril MA, Zheng Y, Wang J, Shrubsole MJ, Su T, Mi X, Kocherginsky M, Rodriguez LM, Della'Zanna G, Richmond E, Hou L, Khan SA, Dai Q. Evaluating Intermittent Dosing of Aspirin for Colorectal Cancer Chemoprevention. Cancer Prev Res (Phila). 2025 Jun 2;18(6):321-334. doi: 10.1158/1940-6207.CAPR-24-0168.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qi Dai principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Aspirin, Biospecimen Collection and Questionnaire Administration in people with Colorectal Adenoma and Colorectal Carcinoma, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ratio of Cell Proliferation to Apoptosis Biomarkers (Ki67 Index and BAX Index) (time frame: Baseline to end of intervention up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02965703, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.