Colorectal CancerEarly Phase 1NCT05056896
ASPIRED-XT: ASPirin Intervention for the REDuction of Colorectal Cancer Risk -EXTension
A Early Phase 1 study testing Aspirin in people with Colorectal Cancer, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This research study is studying a drug intervention as a possible chemoprevention strategy for colorectal cancer. The name of the study intervention involved in this study is: Low Dose Aspirin Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Aspirin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 161 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jun 2022to 31 Dec 2026
- Phase
- Early Phase 1
- 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
- Participants must have undergone screening or surveillance colonoscopy with removal of at least one adenoma within the last 9 months.
- Age greater than or equal to 18 years and less than 55 years or greater than or equal to 65 years at the time of enrollment This study will only include adult participants because colorectal carcinogenesis in children is more likely to be related to a cancer predisposition syndrome with distinct biological mechanisms compared with sporadic colorectal cancer in adults.
- ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A).
- Not currently taking aspirin (any dose) within the last 6 months.
- The effects of aspirin on the developing human fetus are unknown. For this reason, women of child-bearing potential 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 she is participating in this study, she should inform her treating physician immediately.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Use of any non-aspirin non-steroidal anti-inflammatory drug (NSAID) at any dose at least three times a week during the two months prior to randomization.
- Diagnosis of inflammatory bowel disease, liver or kidney disease, bleeding diathesis.
- Any prior diagnosis of gastrointestinal cancer (including esophageal, small intestine, colon, pancreatic), or any diagnosis of other cancers (with the exception of non-melanoma skin) in which there has been any active treatment within the last three years.
- Participants who are receiving any other investigational agents.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to aspirin.
- Known diagnosis of Familial Adenomatous Polyposis (FAP) or Hereditary Non-Polyposis Colorectal Cancer (HNPCC, Lynch Syndrome).
Show all 13Show fewer
- Any adenoma that was not completely removed during previous colonoscopy.
- History of aspirin intolerance, bleeding diathesis, peptic ulcer or gastrointestinal bleed, endoscopic complications, or contraindication to colonoscopy.
- Inability or unwillingness to abstain from non-protocol use of aspirin or NSAIDs or to provide blood, urine, or stool samples or colon biopsies during the study.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant or breastfeeding. Pregnant women are excluded from this study because aspirin is an FDA Category D agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with aspirin, breastfeeding should be discontinued if the mother is treated with aspirin.
- Participant must be able to swallow pills.
- Participant is taking any anticoagulant agent (e.g. warfarin) or antiplatelet agent (e.g. clopidogrel).
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
About this study
This research study is studying a drug intervention as a possible chemoprevention strategy for colorectal cancer.
The name of the study intervention involved in this study is:
- Low Dose Aspirin
Read the detailed description
This is prospective, double-blind, placebo-controlled, randomized clinical trial to measure the effects of daily low-dose (81 mg/day) aspirin on tissue, urine, plasma, and stool biomarkers associated with colorectal cancer with a focus on the effect of age. It is a direct extension of an earlier study: ASPIRED trial NCT02394769
Aspirin is part of the non-steroidal anti-inflammatory drug (NSAID) family, which are drugs routinely used for their pain-killing (analgesic), fever-reducing (antipyretic), or anti-inflammatory properties. Most NSAIDs are available as over-the-counter formulations. Substantial evidence has conclusively demonstrated that aspirin reduces the risk of colorectal polyps and cancer, yet there remains uncertainty surrounding its mode of action. Aspirin may prevent colorectal cancer through multiple interrelated biological mechanisms including the reduction of chronic inflammation, a known risk factor for colorectal cancer. Aspirin has been shown to directly affect prostaglandins, a class of biologic molecules that play important roles in controlling the normal inflammatory responses within your body. The exact mechanism by which aspirin acts to prevent colorectal cancer is still unknown.This study is looking at the mechanisms of aspirin's anti-cancer effect, which may lead to the discovery of novel specific characteristics (markers) that can be used to select patients for aspirin treatment. the study will also look at the effect age may have on these mechanisms.
The research study procedures include screening for eligibility and study treatment and scheduling two clinical research visits immediately before and after intervention with the study drug.
Participants will be randomized into two groups.
- Arm A: Daily Placebo (no aspirin) for the duration of the study.
- Arm B: Daily low dose aspirin (81 mg/day) for the duration of the study.
Participants may be contacted periodically after the study (no more than 1- 2 times annually) for up to 10 years to follow-up on additional information including any continued aspirin use or follow-up colonoscopy results.
It is expected that about 160 people will take part in this research study.
The National Cancer Institute (NCI) of the National Institutes of Health (NIH) is supporting this research study by providing funding for the research study.
- Conditions
- Colorectal Cancer
- Being tested
- Aspirin, Placebo
- Keywords
- Colorectal Cancer
- 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), Salicylic Acid Acetate
Capsule taken orally
PlaceboOther
Capsule taken orally
| Study group | Role | What they receive |
|---|---|---|
| Low Dose Aspirin | Experimental | Participants will be randomly assigned to aspirin group and receive a daily low dose aspirin (81 mg) for the duration of the study up to 12 weeks. Receives: Drug: Aspirin |
| Placebo | Experimental | Participants will be randomly assigned to placebo group and receive a daily placebo capsule for the duration of the study up to 12 weeks. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Intestinal Stem Cell Marker Gene Expression
All patients with available pre- and post-treatment samples containing high-quality RNA sequencing reads from at least 1,000 EPCAM+ single cells per time point were included in the analysis. Single cells were clustered according to cell type. The proportion (%) of cells expressing LGR5 (LGR5+), an accepted intestinal stem cell (ISC) marker of cell stemness, among the ISC cluster was calculated for each participant at each time point. The change in proportion of LGR5+ ISCs within each individual in post-treatment samples from pre-treatment samples was calculated.
Measured: 2 months
Secondary outcomes (5)
Change in Urinary PGE-M
Comparing change in PGE-M between treatment groups (aspirin and placebo) using a two-sample t-test.
Measured: 2 months
Change in Urinary Plasma GDF-15
Comparing change inGDF-15 between aspirin and placebo groups, using a two-sample t-test.
Measured: 2 months
ChIP-seq Analysis of Colonic Epithelium
Analysis of the ChIP-seq data (>60 million reads, 50-bp paired end) using the publicly available Cistrome Analysis Pipeline
Measured: 2 months
Gene Expression Analysis of Colonic Epithelium
RNA-seq sequence data (> 50 million reads) will be mapped to hg19 through use of TopHat2.
Measured: 2 months
Change in Microbiome
Aspirin use and dose will be associated with microbial operational taxonomic units (OTUs) using the Biobakery3 computational analysis pipeline.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2021
- Study start3 Jun 2022
- Primary completion27 Nov 2024
- Study completion31 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.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Andrew T. Chan, MD, MPH, Massachusetts General Hospital
- Investigators
- Andrew T Chan, MD, MPH, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05056896
- Sponsor's protocol ID
- 21-376
- Other IDs
- R01CA243454, R01CA257523, R35CA253185-01, K01DK120742-01A1
- Status last verified
- May 2026
- First submitted
- 15 Sep 2021
- Last updated
- 22 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ASPIRED-XT: ASPirin Intervention for the REDuction of Colorectal Cancer Risk -EXTension
- ClinicalTrials.gov ID
- NCT05056896
- Acronym / sponsor ID
- 21-376
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal Cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH)
- Study start
- 3 Jun 2022 (actual)
- Primary completion
- 27 Nov 2024 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 27 Sep 2021 (actual)
- Results
- Posted 15 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study is studying a drug intervention as a possible chemoprevention strategy for colorectal cancer.
The name of the study intervention involved in this study is:
- Low Dose Aspirin
Detailed description
This is prospective, double-blind, placebo-controlled, randomized clinical trial to measure the effects of daily low-dose (81 mg/day) aspirin on tissue, urine, plasma, and stool biomarkers associated with colorectal cancer with a focus on the effect of age. It is a direct extension of an earlier study: ASPIRED trial NCT02394769
Aspirin is part of the non-steroidal anti-inflammatory drug (NSAID) family, which are drugs routinely used for their pain-killing (analgesic), fever-reducing (antipyretic), or anti-inflammatory properties. Most NSAIDs are available as over-the-counter formulations. Substantial evidence has conclusively demonstrated that aspirin reduces the risk of colorectal polyps and cancer, yet there remains uncertainty surrounding its mode of action. Aspirin may prevent colorectal cancer through multiple interrelated biological mechanisms including the reduction of chronic inflammation, a known risk factor for colorectal cancer. Aspirin has been shown to directly affect prostaglandins, a class of biologic molecules that play important roles in controlling the normal inflammatory responses within your body. The exact mechanism by which aspirin acts to prevent colorectal cancer is still unknown.This study is looking at the mechanisms of aspirin's anti-cancer effect, which may lead to the discovery of novel specific characteristics (markers) that can be used to select patients for aspirin treatment. the study will also look at the effect age may have on these mechanisms.
The research study procedures include screening for eligibility and study treatment and scheduling two clinical research visits immediately before and after intervention with the study drug.
Participants will be randomized into two groups.
- Arm A: Daily Placebo (no aspirin) for the duration of the study.
- Arm B: Daily low dose aspirin (81 mg/day) for the duration of the study.
Participants may be contacted periodically after the study (no more than 1- 2 times annually) for up to 10 years to follow-up on additional information including any continued aspirin use or follow-up colonoscopy results.
It is expected that about 160 people will take part in this research study.
The National Cancer Institute (NCI) of the National Institutes of Health (NIH) is supporting this research study by providing funding for the research study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Dose Aspirin | Experimental | Drug: AspirinParticipants will be randomly assigned to aspirin group and receive a daily low dose aspirin (81 mg) for the duration of the study up to 12 weeks. |
| Placebo | Experimental | Other: PlaceboParticipants will be randomly assigned to placebo group and receive a daily placebo capsule for the duration of the study up to 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participants must have undergone screening or surveillance colonoscopy with removal of at least one adenoma within the last 9 months.
- Age greater than or equal to 18 years and less than 55 years or greater than or equal to 65 years at the time of enrollment This study will only include adult participants because colorectal carcinogenesis in children is more likely to be related to a cancer predisposition syndrome with distinct biological mechanisms compared with sporadic colorectal cancer in adults.
- ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A).
- Not currently taking aspirin (any dose) within the last 6 months.
- The effects of aspirin on the developing human fetus are unknown. For this reason, women of child-bearing potential 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 she is participating in this study, she should inform her treating physician immediately.
Key exclusion criteria (13 listed)
- Use of any non-aspirin non-steroidal anti-inflammatory drug (NSAID) at any dose at least three times a week during the two months prior to randomization.
- Diagnosis of inflammatory bowel disease, liver or kidney disease, bleeding diathesis.
- Any prior diagnosis of gastrointestinal cancer (including esophageal, small intestine, colon, pancreatic), or any diagnosis of other cancers (with the exception of non-melanoma skin) in which there has been any active treatment within the last three years.
- Participants who are receiving any other investigational agents.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to aspirin.
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), Salicylic Acid AcetateCapsule taken orally | Drug | Low Dose Aspirin |
| PlaceboCapsule taken orally | Other | Placebo |
Primary outcome
Change of Intestinal Stem Cell Marker Gene Expression
Time frame: 2 months
All patients with available pre- and post-treatment samples containing high-quality RNA sequencing reads from at least 1,000 EPCAM+ single cells per time point were included in the analysis. Single cells were clustered according to cell type. The proportion (%) of cells expressing LGR5 (LGR5+), an accepted intestinal stem cell (ISC) marker of cell stemness, among the ISC cluster was calculated for each participant at each time point. The change in proportion of LGR5+ ISCs within each individual in post-treatment samples from pre-treatment samples was calculated.
5 secondary outcomes
Change in Urinary PGE-M
Time frame: 2 months
Change in Urinary Plasma GDF-15
Time frame: 2 months
ChIP-seq Analysis of Colonic Epithelium
Time frame: 2 months
Gene Expression Analysis of Colonic Epithelium
Time frame: 2 months
Change in Microbiome
Time frame: 2 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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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.
Andrew T Chan, MD, MPH principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Aspirin in people with Colorectal Cancer, run by Massachusetts General Hospital 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 6 inclusion and 13 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 22 Jun 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. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 15 May 2026). 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?
Change of Intestinal Stem Cell Marker Gene Expression (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jun 2026.