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Aspirin in Preventing Colorectal Cancer in Patients at Increased Risk of Colorectal Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00468910
First Posted: May 3, 2007
Last Update Posted: May 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Cancer Institute (NCI)
Results First Submitted: December 15, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Conditions: Colon Cancer
Precancerous Condition
Rectal Cancer
Interventions: Drug: acetylsalicylic acid
Drug: placebo
Other: laboratory biomarker analysis

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study opened to accrual 02/22/2007 and closed to accrual 08/10/2009. Subjects were recruited at Northwestern University and University of Chicago.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 110 subjects met the clinical definition of high risk for colorectal cancer, were entered onto the trial, and underwent initial spectral analysis. Of these, 81 had a cancer-associated spectral signature in histologically normal colonic mucosa.79 of these 81 subjects were randomized and began the study intervention

Reporting Groups
  Description
Acetylsalicylic Acid Patients receive oral acetylsalicylic acid (aspirin) once daily.
Placebo Patients receive oral placebo once daily.

Participant Flow:   Overall Study
    Acetylsalicylic Acid   Placebo
STARTED   40   39 
Randomization   40   39 
Treatment   36   36 
Post-Treatment Biopsy   36   36 
Follow-up   36   36 
COMPLETED   36   36 
NOT COMPLETED   4   3 
Lost to Follow-up                2                1 
Withdrawal by Subject                2                1 
Medical Contraindication                0                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
72 of the 79 subjects who were randomized completed the primary endpoint (3-month tissue biopsy); 36 from each arm.

Reporting Groups
  Description
Acetylsalicylic Acid Patients receive oral acetylsalicylic acid (aspirin) once daily.
Placebo Patients receive oral placebo once daily.
Total Total of all reporting groups

Baseline Measures
   Acetylsalicylic Acid   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 40   39   79 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      33  82.5%      34  87.2%      67  84.8% 
>=65 years      7  17.5%      5  12.8%      12  15.2% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      15  37.5%      16  41.0%      31  39.2% 
Male      25  62.5%      23  59.0%      48  60.8% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      3   7.5%      0   0.0%      3   3.8% 
Not Hispanic or Latino      37  92.5%      39 100.0%      76  96.2% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      2   5.1%      2   2.5% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      2   5.0%      1   2.6%      3   3.8% 
White      37  92.5%      36  92.3%      73  92.4% 
More than one race      1   2.5%      0   0.0%      1   1.3% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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. ]

2.  Primary:   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. ]

3.  Secondary:   Colonic Epithelial Apoptosis as Measured by Immunohistochemical Detection of Cleaved Caspase 3   [ Time Frame: 3 months from baseline colonoscopy to end of intervention. ]

4.  Secondary:   Changes in Colonic Cell Proliferation as Measured by Immunohistochemical Detection of Ki67   [ Time Frame: 3 months from baseline colonoscopy to end of intervention. ]

5.  Secondary:   Rectal Prostaglandin Levels as Measured by ELISA   [ Time Frame: 3 months from baseline colonoscopy to end of intervention. ]

6.  Other Pre-specified:   Platelet Cyclooxygenase (COX) Activity as Measured by a Peroxidase-based COX Enzyme Activity Assay   [ Time Frame: 3 months from baseline colonoscopy to end of intervention. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Seema Khan
Organization: Northwestern University
phone: 312-503- 4236
e-mail: skhan@nm.org


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00468910     History of Changes
Other Study ID Numbers: NCI-2009-00841
NCI-2009-00841 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000652929
NCI 04-2-03 ( Other Identifier: Northwestern University )
NWU04-2-03 ( Other Identifier: DCP )
N01CN35157 ( U.S. NIH Grant/Contract )
First Submitted: May 2, 2007
First Posted: May 3, 2007
Results First Submitted: December 15, 2015
Results First Posted: May 31, 2017
Last Update Posted: May 31, 2017