Trial Outcomes & Findings for ASPIRED-XT: ASPirin Intervention for the REDuction of Colorectal Cancer Risk -EXTension (NCT NCT05056896)
NCT ID: NCT05056896
Last Updated: 2026-05-15
Results Overview
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.
ACTIVE_NOT_RECRUITING
EARLY_PHASE1
161 participants
2 months
2026-05-15
Participant Flow
Potentially eligible patients were contacted by letter or directly approached by a treating physician if they were identified as having a recent history of colorectal adenoma by their treating physician or via natural language processing searches of the pathology database at Mass General Brigham. If no response to the letter is received, participants are contacted by phone (unless they have otherwise opted out) by a member of the study team. If interested, they are then screened for eligibility
Participants are screened for eligibility criteria by a member of the study staff and provide written informed consent prior to any research activities. Eligible and consented participants are stratified according to age group: younger (18-55 years of age) or older (65+ years of age), prior to randomization.
Participant milestones
| Measure |
Adults 18-55 Years of Age Randomized to Low Dose Aspirin
Participants are stratified according to age group prior to randomization. These participants are adults between 18 and 55 years of age and randomized to Low Dose Aspirin and receive blinded capsules containing 81 mg of aspirin to be taken daily for at least 8 weeks.
|
Adults 18-55 Years of Age Randomized to Placebo
Participants are stratified according to age group prior to randomization. These participants are adults between 18 and 55 years of age and randomized to placebo and receive blinded capsules containing placebo to be taken daily for at least 8 weeks.
|
Adults 65+ Years of Age Randomized to Low Dose Aspirin
Participants are stratified according to age group prior to randomization. These participants are adults 65+ years of age and randomized to Low Dose Aspirin and receive blinded capsules containing 81 mg of aspirin to be taken daily for at least 8 weeks.
|
Older: Adults 65+ Years of Age or Older Randomized to Placebo
Participants are stratified according to age group prior to randomization. These participants are adults 65+ years of age and randomized to placebo and receive blinded capsules containing placebo to be taken daily for at least 8 weeks.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
41
|
40
|
|
Overall Study
COMPLETED
|
34
|
39
|
37
|
39
|
|
Overall Study
NOT COMPLETED
|
6
|
1
|
4
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
ASPIRED-XT: ASPirin Intervention for the REDuction of Colorectal Cancer Risk -EXTension
Baseline characteristics by cohort
| Measure |
Low Dose Aspirin
n=81 Participants
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.
Aspirin: Capsule taken orally
|
Placebo
n=80 Participants
Participants will be randomly assigned to placebo group and receive a daily placebo capsule for the duration of the study up to 12 weeks.
Placebo: Capsule taken orally
|
Total
n=161 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
40 Participants
n=11 Participants
|
40 Participants
n=9 Participants
|
80 Participants
n=20 Participants
|
|
Age, Categorical
>=65 years
|
41 Participants
n=11 Participants
|
40 Participants
n=9 Participants
|
81 Participants
n=20 Participants
|
|
Age, Continuous
|
60 years
n=11 Participants
|
59.7 years
n=9 Participants
|
59.85093168 years
n=20 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=11 Participants
|
40 Participants
n=9 Participants
|
85 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=11 Participants
|
40 Participants
n=9 Participants
|
76 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=11 Participants
|
6 Participants
n=9 Participants
|
13 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
73 Participants
n=11 Participants
|
74 Participants
n=9 Participants
|
147 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=11 Participants
|
3 Participants
n=9 Participants
|
7 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=11 Participants
|
2 Participants
n=9 Participants
|
3 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
72 Participants
n=11 Participants
|
73 Participants
n=9 Participants
|
145 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=11 Participants
|
1 Participants
n=9 Participants
|
3 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=11 Participants
|
1 Participants
n=9 Participants
|
3 Participants
n=20 Participants
|
|
Region of Enrollment
United States
|
81 participants
n=11 Participants
|
80 participants
n=9 Participants
|
161 participants
n=20 Participants
|
|
BMI
|
27.17 kg/m^2
n=11 Participants
|
27.8615461 kg/m^2
n=9 Participants
|
27.5129332 kg/m^2
n=20 Participants
|
PRIMARY outcome
Timeframe: 2 monthsPopulation: The primary outcome analysis was performed in 25 individuals who had available single-cell RNA sequencing data from at least 1,000 high quality EPCAM+ cells at both the pre- and post-treatment timepoint. This is a subset of the total study population. Randomization is preserved among those remaining in the final analysis and they are representative of the final study population. Future analyses will validate positive primary findings in the remaining study population using correlative approaches
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.
Outcome measures
| Measure |
Adults 18-55 Years of Age Randomized to Low Dose Aspirin
n=5 Participants
Participants are stratified according to age group prior to randomization. These participants are adults between 18 and 55 years of age and randomized to Low Dose Aspirin and receive blinded capsules containing 81 mg of aspirin to be taken daily for at least 8 weeks.
|
Adults 18-55 Years of Age Randomized to Placebo
n=7 Participants
Participants are stratified according to age group prior to randomization. These participants are adults between 18 and 55 years of age and randomized to placebon and receive blinded capsules containing placebo to be taken daily for at least 8 weeks.
|
Adults 65+ Years of Age Randomized to Low Dose Aspirin
n=7 Participants
Participants are stratified according to age group prior to randomization. These participants are adults 65+ years of age and randomized to Low Dose Aspirin and receive blinded capsules containing 81 mg of aspirin to be taken daily for at least 8 weeks.
|
Adults 65 Years of Age or Older Randomized to Placebo
n=6 Participants
Participants are stratified according to age group prior to randomization. These participants are adults 65+ years of age and randomized to placebo and receive blinded capsules containing placebo to be taken daily for at least 8 weeks.
|
|---|---|---|---|---|
|
Change of Intestinal Stem Cell Marker Gene Expression
|
3.4 Percent Change of LGR5+ Stem Cells
Standard Deviation 7.6
|
-9.1 Percent Change of LGR5+ Stem Cells
Standard Deviation 7.0
|
-0.36 Percent Change of LGR5+ Stem Cells
Standard Deviation 12.2
|
6.4 Percent Change of LGR5+ Stem Cells
Standard Deviation 5.1
|
SECONDARY outcome
Timeframe: 2 monthsComparing change in PGE-M between treatment groups (aspirin and placebo) using a two-sample t-test.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 monthsComparing change inGDF-15 between aspirin and placebo groups, using a two-sample t-test.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 monthsAnalysis of the ChIP-seq data (\>60 million reads, 50-bp paired end) using the publicly available Cistrome Analysis Pipeline
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 monthsRNA-seq sequence data (\> 50 million reads) will be mapped to hg19 through use of TopHat2.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 monthsAspirin use and dose will be associated with microbial operational taxonomic units (OTUs) using the Biobakery3 computational analysis pipeline.
Outcome measures
Outcome data not reported
Adverse Events
Adults 18-55 Years of Age Randomized to Low Dose Aspirin
Adults 18-55 Years of Age Randomized to Placebo
Adults 65+ Years of Age Randomized to Low Dose Aspirin
Adults 65 Years of Age or Older Randomized to Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Adults 18-55 Years of Age Randomized to Low Dose Aspirin
n=40 participants at risk
Participants are stratified according to age group prior to randomization. These participants are adults between 18 and 55 years of age and randomized to Low Dose Aspirin and receive blinded capsules containing 81 mg of aspirin to be taken daily for at least 8 weeks.
|
Adults 18-55 Years of Age Randomized to Placebo
n=40 participants at risk
Participants are stratified according to age group prior to randomization. These participants are adults between 18 and 55 years of age and randomized to placebon and receive blinded capsules containing placebo to be taken daily for at least 8 weeks.
|
Adults 65+ Years of Age Randomized to Low Dose Aspirin
n=41 participants at risk
Participants are stratified according to age group prior to randomization. These participants are adults 65+ years of age and randomized to Low Dose Aspirin and receive blinded capsules containing 81 mg of aspirin to be taken daily for at least 8 weeks.
|
Adults 65 Years of Age or Older Randomized to Placebo
n=40 participants at risk
Participants are stratified according to age group prior to randomization. These participants are adults 65+ years of age and randomized to placebo and receive blinded capsules containing placebo to be taken daily for at least 8 weeks.
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Rotator Cuff injury
|
0.00%
0/40 • 3 months
|
0.00%
0/40 • 3 months
|
2.4%
1/41 • 3 months
|
0.00%
0/40 • 3 months
|
|
Infections and infestations
Wound infection
|
0.00%
0/40 • 3 months
|
0.00%
0/40 • 3 months
|
0.00%
0/41 • 3 months
|
2.5%
1/40 • 3 months
|
|
Skin and subcutaneous tissue disorders
Dog Bite
|
0.00%
0/40 • 3 months
|
0.00%
0/40 • 3 months
|
2.4%
1/41 • 3 months
|
0.00%
0/40 • 3 months
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
2.5%
1/40 • 3 months
|
2.5%
1/40 • 3 months
|
2.4%
1/41 • 3 months
|
2.5%
1/40 • 3 months
|
|
Gastrointestinal disorders
Nausea
|
2.5%
1/40 • 3 months
|
5.0%
2/40 • 3 months
|
0.00%
0/41 • 3 months
|
2.5%
1/40 • 3 months
|
|
General disorders
Fatigue
|
2.5%
1/40 • 3 months
|
0.00%
0/40 • 3 months
|
2.4%
1/41 • 3 months
|
2.5%
1/40 • 3 months
|
|
General disorders
Fever
|
0.00%
0/40 • 3 months
|
0.00%
0/40 • 3 months
|
2.4%
1/41 • 3 months
|
5.0%
2/40 • 3 months
|
|
Renal and urinary disorders
Urinary Tract Infection
|
0.00%
0/40 • 3 months
|
0.00%
0/40 • 3 months
|
2.4%
1/41 • 3 months
|
5.0%
2/40 • 3 months
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/40 • 3 months
|
0.00%
0/40 • 3 months
|
2.4%
1/41 • 3 months
|
2.5%
1/40 • 3 months
|
|
Gastrointestinal disorders
Constipation
|
2.5%
1/40 • 3 months
|
2.5%
1/40 • 3 months
|
0.00%
0/41 • 3 months
|
0.00%
0/40 • 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/40 • 3 months
|
2.5%
1/40 • 3 months
|
4.9%
2/41 • 3 months
|
0.00%
0/40 • 3 months
|
|
Nervous system disorders
Dizziness
|
2.5%
1/40 • 3 months
|
0.00%
0/40 • 3 months
|
2.4%
1/41 • 3 months
|
0.00%
0/40 • 3 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/40 • 3 months
|
2.5%
1/40 • 3 months
|
0.00%
0/41 • 3 months
|
0.00%
0/40 • 3 months
|
|
General disorders
Pain
|
5.0%
2/40 • 3 months
|
7.5%
3/40 • 3 months
|
4.9%
2/41 • 3 months
|
10.0%
4/40 • 3 months
|
|
Psychiatric disorders
Psychiatric disorders, other
|
0.00%
0/40 • 3 months
|
2.5%
1/40 • 3 months
|
0.00%
0/41 • 3 months
|
0.00%
0/40 • 3 months
|
|
Gastrointestinal disorders
Rectal Hemorrhage
|
0.00%
0/40 • 3 months
|
0.00%
0/40 • 3 months
|
0.00%
0/41 • 3 months
|
2.5%
1/40 • 3 months
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders, other
|
0.00%
0/40 • 3 months
|
0.00%
0/40 • 3 months
|
4.9%
2/41 • 3 months
|
0.00%
0/40 • 3 months
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/40 • 3 months
|
2.5%
1/40 • 3 months
|
2.4%
1/41 • 3 months
|
0.00%
0/40 • 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection
|
2.5%
1/40 • 3 months
|
0.00%
0/40 • 3 months
|
0.00%
0/41 • 3 months
|
2.5%
1/40 • 3 months
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
2.5%
1/40 • 3 months
|
0.00%
0/40 • 3 months
|
0.00%
0/41 • 3 months
|
2.5%
1/40 • 3 months
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/40 • 3 months
|
5.0%
2/40 • 3 months
|
0.00%
0/41 • 3 months
|
0.00%
0/40 • 3 months
|
|
Investigations
Weight gain
|
0.00%
0/40 • 3 months
|
0.00%
0/40 • 3 months
|
0.00%
0/41 • 3 months
|
5.0%
2/40 • 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Allergic Rhinitis
|
0.00%
0/40 • 3 months
|
2.5%
1/40 • 3 months
|
0.00%
0/41 • 3 months
|
0.00%
0/40 • 3 months
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
2.5%
1/40 • 3 months
|
0.00%
0/40 • 3 months
|
0.00%
0/41 • 3 months
|
0.00%
0/40 • 3 months
|
|
Eye disorders
Conjunctivitis infective
|
0.00%
0/40 • 3 months
|
0.00%
0/40 • 3 months
|
2.4%
1/41 • 3 months
|
0.00%
0/40 • 3 months
|
|
Gastrointestinal disorders
Dysphagia
|
2.5%
1/40 • 3 months
|
0.00%
0/40 • 3 months
|
0.00%
0/41 • 3 months
|
0.00%
0/40 • 3 months
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/40 • 3 months
|
0.00%
0/40 • 3 months
|
0.00%
0/41 • 3 months
|
2.5%
1/40 • 3 months
|
|
General disorders
Generalized Edema
|
0.00%
0/40 • 3 months
|
0.00%
0/40 • 3 months
|
0.00%
0/41 • 3 months
|
2.5%
1/40 • 3 months
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.00%
0/40 • 3 months
|
0.00%
0/40 • 3 months
|
2.4%
1/41 • 3 months
|
0.00%
0/40 • 3 months
|
|
Skin and subcutaneous tissue disorders
Hematoma
|
2.5%
1/40 • 3 months
|
0.00%
0/40 • 3 months
|
0.00%
0/41 • 3 months
|
0.00%
0/40 • 3 months
|
|
Musculoskeletal and connective tissue disorders
Hip Fracture
|
0.00%
0/40 • 3 months
|
0.00%
0/40 • 3 months
|
2.4%
1/41 • 3 months
|
0.00%
0/40 • 3 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/40 • 3 months
|
0.00%
0/40 • 3 months
|
2.4%
1/41 • 3 months
|
0.00%
0/40 • 3 months
|
|
Vascular disorders
Hypertension
|
0.00%
0/40 • 3 months
|
0.00%
0/40 • 3 months
|
2.4%
1/41 • 3 months
|
0.00%
0/40 • 3 months
|
|
Reproductive system and breast disorders
Menorrhagia
|
2.5%
1/40 • 3 months
|
0.00%
0/40 • 3 months
|
0.00%
0/41 • 3 months
|
0.00%
0/40 • 3 months
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/40 • 3 months
|
5.0%
2/40 • 3 months
|
9.8%
4/41 • 3 months
|
2.5%
1/40 • 3 months
|
|
Nervous system disorders
Headache
|
7.5%
3/40 • 3 months
|
5.0%
2/40 • 3 months
|
2.4%
1/41 • 3 months
|
0.00%
0/40 • 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/40 • 3 months
|
5.0%
2/40 • 3 months
|
4.9%
2/41 • 3 months
|
5.0%
2/40 • 3 months
|
|
Infections and infestations
Flu like symptoms
|
20.0%
8/40 • 3 months
|
15.0%
6/40 • 3 months
|
9.8%
4/41 • 3 months
|
17.5%
7/40 • 3 months
|
|
Infections and infestations
Infections and infestations - other, specify
|
7.5%
3/40 • 3 months
|
2.5%
1/40 • 3 months
|
12.2%
5/41 • 3 months
|
5.0%
2/40 • 3 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place