Colon CancerPhase 2NCT00468910
Aspirin in Preventing Colorectal Cancer in Patients at Increased Risk of Colorectal Cancer
A Phase 2 study testing acetylsalicylic acid and laboratory biomarker analysis in people with Colon Cancer and Precancerous Condition, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
This randomized phase II trial is studying how well aspirin works in preventing colorectal cancer in patients at increased risk of colorectal cancer. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of aspirin may prevent colorectal cancer. Read more about this study
- Who is it for?
- Ages Up to 75 years
- Conditions the study is for
- Colon Cancer, Precancerous Condition, Rectal Cancer
- What is being tested?
- acetylsalicylic acid and laboratory biomarker analysis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 79 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to Aug 2011
- 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 Up to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Criteria:
- No active or metastatic cancer within the past 6 months
- Scheduled to undergo colonoscopy for colonic neoplasia surveillance
- Hemoglobin >= 12.0 g/dL
- Platelet count >= 120,000/mm^3
- AST or ALT =< 1.5 times upper limit of normal (ULN)
- Alkaline phosphatase =< 1.5 times ULN
- Bilirubin =< 1.5 times ULN
- BUN =< 40 mg/dL
- Glomerular filtration rate >= 45 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No coagulopathy
- No anemia
- No history of peptic ulcer disease or gastrointestinal hemorrhage
- No history of cerebrovascular accident
- No uncontrolled hypertension
- No history of intolerance or allergy to aspirin or to NSAIDs
- No liver disease as manifested by signs or symptoms of cirrhosis
- No endoscopic or radiographic evidence of portal hypertension
- No active colitis by endoscopy
- No history of inflammatory bowel disease
- No requirement for aspirin as medical therapy (i.e., post-myocardial infarction or transient ischemic attack)
- No untreated helicobacter pylori infection
- History of significant colonic neoplasia, defined as 1 of the following:
- Adenoma within the past 6 years
- Colorectal cancer within the past 6 years
- Known adenoma on present exam
- Histologically confirmed polyps seen on imaging
- INR =< 1.5
- At least 6 months since prior cancer treatment
- No other concurrent acetylsalicylic acid (aspirin)-containing products or non-steroidal anti-inflammatory drugs (NSAIDs)
- No concurrent systemic corticosteroids
- No other concurrent anticoagulants or antiplatelet agents
- No concurrent investigational drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Spectral Markers in Aspirin Chemoprevention of Colonic Neoplasia
This randomized phase II trial is studying how well aspirin works in preventing colorectal cancer in patients at increased risk of colorectal cancer. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of aspirin may prevent colorectal cancer.
Read the detailed description
PRIMARY OBJECTIVE:
- Determine whether acetylsalicylic acid (aspirin) will alter spectral markers (i.e., spectral slope and fractal dimension) in distal colonic mucosa of patients who are at increased risk for the development or recurrence of colorectal cancer.
SECONDARY OBJECTIVES:
- Assess the effect of this drug on colonic epithelial apoptosis and cell proliferation in these patients.
II. Assess the effect of this drug on rectal prostaglandin levels in these patients.
III. Assess the effect of this drug on platelet cyclooxygenase activity in these patients.
IV. Correlate changes in spectral markers with UGT1A6 genotype in patients treated with this drug.
OUTLINE: This is a multicenter, randomized, double-blind, placebo-controlled study. Patients are stratified by clinical site and adenoma/carcinoma maximal size. Patients with abnormal spectral biomarkers are randomized to 1 of 2 treatment arms.
ARM I: Patients receive oral acetylsalicylic acid (aspirin) once daily.
ARM II: Patients receive oral placebo once daily.
In both arms, treatment continues for 3 months in the absence of unacceptable toxicity.
Patients undergo flexible sigmoidoscopy and biopsies as well as blood collection at baseline (during prestudy colonoscopy) and at completion of study treatment for comparison of spectral signatures with biomarkers of both aspirin activity (including plasma cyclooxygenase activity and rectal prostaglandin levels) as well as with biomarkers associated with antineoplastic alteration (including apoptosis and cell proliferation). UGT1A6 genotyping analysis is also performed.
After completion of study treatment, patients are followed at 3 months.
- Conditions
- Colon Cancer, Precancerous Condition, Rectal Cancer
- Being tested
- acetylsalicylic acid, placebo, laboratory biomarker analysis
- Medical subject headings
- Colonic Neoplasms, Precancerous Conditions, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acetylsalicylic acidDrug
Also called ASA, Ecotrin, Empirin, Extren
Given orally
placeboDrug
Also called PLCB
Given orally
laboratory biomarker analysisOther
Correlative study
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients receive oral acetylsalicylic acid (aspirin) once daily. Receives: Drug: acetylsalicylic acid; Other: laboratory biomarker analysis |
| Arm II | Placebo comparator | Patients receive oral placebo once daily. Receives: Drug: placebo; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of a Spectral Biomarker for Colonic Carcinogenesis (Called Spectral Slope or SPEC) From Baseline to 3 Months.
Spectral marker assessment was performed via LEBS analysis (low-coherence enhanced backscattering spectroscopy) on the uninvolved mucosal biopsies of subjects taken at baseline and after 3 months of treatment with either aspirin or placebo. SPEC characterizes the size distribution of macromolecular complexes and other intracellular structures, with a decrease of the spectral slope implying a shift of the size distribution of intracellular structures toward smaller sizes.
Spectral markers SPEC and FRAC provide a measure of the fundamental characteristics of the tissue nanoscale architecture.
Measured: 3 months from baseline colonoscopy to end of intervention.
Change of a Spectral Biomarker for Colonic Carcinogenesis (Called Fractal Dimension or FRAC) From Baseline to 3 Months.
Spectral marker assessment was performed via LEBS analysis (low-coherence enhanced backscattering spectroscopy) on the uninvolved mucosal biopsies of subjects taken at baseline and after 3 months of treatment with either aspirin or placebo. FRAC characterizes the spatial autocorrelation function of mass density distribution in tissue.
SPEC and FRAC provide a measure of the fundamental characteristics of the tissue nanoscale architecture
Measured: 3 months from baseline colonoscopy to end of intervention.
Secondary outcomes (3)
Colonic Epithelial Apoptosis as Measured by Immunohistochemical Detection of Cleaved Caspase 3
Evaluate the effect of aspirin on colonic epithelial apoptosis and cell proliferation as assessed by immunohistochemical detection of cleaved caspase 3 .These were performed on samples that had been previously analyzed for 4D-ELF.
Measured: 3 months from baseline colonoscopy to end of intervention.
Changes in Colonic Cell Proliferation as Measured by Immunohistochemical Detection of Ki67
Evaluate the effect of aspirin on colonic epithelial apoptosis and cell proliferation as assessed by immunohistochemical detection of Ki-67. These were performed on samples that had been previously analyzed for 4D-ELF.
Measured: 3 months from baseline colonoscopy to end of intervention.
Rectal Prostaglandin Levels as Measured by ELISA
Evaluate the effect of aspirin on rectal prostaglandin levels.
Measured: 3 months from baseline colonoscopy to end of intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2007 (estimated)
- Study startMar 2007
- Primary completionDec 2009
- Study completionAug 2011
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 Colon CancerStudies 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
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Hemant Roy, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00468910
- Sponsor's protocol ID
- NCI-2009-00841
- Other IDs
- NCI-2009-00841, CDR0000652929, NCI 04-2-03, NWU04-2-03, N01CN35157
- Status last verified
- Apr 2017
- First submitted
- 2 May 2007
- Last updated
- 31 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Roy HK, Turzhitsky V, Wali R, Radosevich AJ, Jovanovic B, Della'Zanna G, Umar A, Rubin DT, Goldberg MJ, Bianchi L, De La Cruz M, Bogojevic A, Helenowski IB, Rodriguez L, Chatterton R, Skripkauskas S, Page K, Weber CR, Huang X, Richmond E, Bergan RC, Backman V. Spectral biomarkers for chemoprevention of colonic neoplasia: a placebo-controlled double-blinded trial with aspirin. Gut. 2017 Feb;66(2):285-292. doi: 10.1136/gutjnl-2015-309996. Epub 2015 Oct 26.
PubMed 26503631
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spectral Markers in Aspirin Chemoprevention of Colonic Neoplasia
- ClinicalTrials.gov ID
- NCT00468910
- Acronym / sponsor ID
- NCI-2009-00841
- Conditions
- Colon Cancer, Precancerous Condition, Rectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Mar 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 3 May 2007 (estimated)
- Results
- Posted 31 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized phase II trial is studying how well aspirin works in preventing colorectal cancer in patients at increased risk of colorectal cancer. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of aspirin may prevent colorectal cancer.
Detailed description
PRIMARY OBJECTIVE:
- Determine whether acetylsalicylic acid (aspirin) will alter spectral markers (i.e., spectral slope and fractal dimension) in distal colonic mucosa of patients who are at increased risk for the development or recurrence of colorectal cancer.
SECONDARY OBJECTIVES:
- Assess the effect of this drug on colonic epithelial apoptosis and cell proliferation in these patients.
II. Assess the effect of this drug on rectal prostaglandin levels in these patients.
III. Assess the effect of this drug on platelet cyclooxygenase activity in these patients.
IV. Correlate changes in spectral markers with UGT1A6 genotype in patients treated with this drug.
OUTLINE: This is a multicenter, randomized, double-blind, placebo-controlled study. Patients are stratified by clinical site and adenoma/carcinoma maximal size. Patients with abnormal spectral biomarkers are randomized to 1 of 2 treatment arms.
ARM I: Patients receive oral acetylsalicylic acid (aspirin) once daily.
ARM II: Patients receive oral placebo once daily.
In both arms, treatment continues for 3 months in the absence of unacceptable toxicity.
Patients undergo flexible sigmoidoscopy and biopsies as well as blood collection at baseline (during prestudy colonoscopy) and at completion of study treatment for comparison of spectral signatures with biomarkers of both aspirin activity (including plasma cyclooxygenase activity and rectal prostaglandin levels) as well as with biomarkers associated with antineoplastic alteration (including apoptosis and cell proliferation). UGT1A6 genotyping analysis is also performed.
After completion of study treatment, patients are followed at 3 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Drug: acetylsalicylic acid, Other: laboratory biomarker analysisPatients receive oral acetylsalicylic acid (aspirin) once daily. |
| Arm II | Placebo comparator | Drug: placebo, Other: laboratory biomarker analysisPatients receive oral placebo once daily. |
Who may qualify
- Ages
- Up to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| acetylsalicylic acidAlso: ASA, Ecotrin, Empirin, ExtrenGiven orally | Drug | Arm I |
| placeboAlso: PLCBGiven orally | Drug | Arm II |
| laboratory biomarker analysisCorrelative study | Other | Arm I, Arm II |
Primary outcome
Change of a Spectral Biomarker for Colonic Carcinogenesis (Called Spectral Slope or SPEC) From Baseline to 3 Months.
Time frame: 3 months from baseline colonoscopy to end of intervention.
Spectral marker assessment was performed via LEBS analysis (low-coherence enhanced backscattering spectroscopy) on the uninvolved mucosal biopsies of subjects taken at baseline and after 3 months of treatment with either aspirin or placebo. SPEC characterizes the size distribution of macromolecular complexes and other intracellular structures, with a decrease of the spectral slope implying a shift of the size distribution of intracellular structures toward smaller sizes. Spectral markers SPEC and FRAC provide a measure of the fundamental characteristics of the tissue nanoscale architecture.
Change of a Spectral Biomarker for Colonic Carcinogenesis (Called Fractal Dimension or FRAC) From Baseline to 3 Months.
Time frame: 3 months from baseline colonoscopy to end of intervention.
Spectral marker assessment was performed via LEBS analysis (low-coherence enhanced backscattering spectroscopy) on the uninvolved mucosal biopsies of subjects taken at baseline and after 3 months of treatment with either aspirin or placebo. FRAC characterizes the spatial autocorrelation function of mass density distribution in tissue. SPEC and FRAC provide a measure of the fundamental characteristics of the tissue nanoscale architecture
3 secondary outcomes
Colonic Epithelial Apoptosis as Measured by Immunohistochemical Detection of Cleaved Caspase 3
Time frame: 3 months from baseline colonoscopy to end of intervention.
Changes in Colonic Cell Proliferation as Measured by Immunohistochemical Detection of Ki67
Time frame: 3 months from baseline colonoscopy to end of intervention.
Rectal Prostaglandin Levels as Measured by ELISA
Time frame: 3 months from baseline colonoscopy to end of intervention.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26503631Roy HK, Turzhitsky V, Wali R, Radosevich AJ, Jovanovic B, Della'Zanna G, Umar A, Rubin DT, Goldberg MJ, Bianchi L, De La Cruz M, Bogojevic A, Helenowski IB, Rodriguez L, Chatterton R, Skripkauskas S, Page K, Weber CR, Huang X, Richmond E, Bergan RC, Backman V. Spectral biomarkers for chemoprevention of colonic neoplasia: a placebo-controlled double-blinded trial with aspirin. Gut. 2017 Feb;66(2):285-292. doi: 10.1136/gutjnl-2015-309996. Epub 2015 Oct 26.
- Individual participant dataSharing planned: Yes
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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.
Hemant Roy 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 acetylsalicylic acid and laboratory biomarker analysis in people with Colon Cancer and Precancerous Condition, 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?
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: finished, as of the sponsor's last update on 31 May 2017. 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 31 May 2017). 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 a Spectral Biomarker for Colonic Carcinogenesis (Called Spectral Slope or SPEC) From Baseline to 3 Months. (time frame: 3 months from baseline colonoscopy to end of intervention.). The study lists 2 primary outcomes in all. 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 NCT00468910, 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 31 May 2017.