Observational Familial Adenomatous Polyposis Registry Study In Patients Receiving Celecoxib Compared to Control Patients

• Time From Ileorectal Anastomosis (IRA) to Time of First Excisional Polypectomy of a Rectal Polyp Post IRA [ Time Frame: Up to 8 years prior to baseline ] [ Designated as safety issue: No ]
  Time(months): [date of first excisional polypectomy of rectal polyp post IRA minus date of prior IRA plus 1] divided by 30.44. Baseline = start of study follow-up: start of on-study celecoxib treatment period for celecoxib-treated subjects and comparable to index date for control subjects. Index date calculated as Matched Celecoxib-treated patients: number of days from most recent FAP-related surgery (IRA or IPAA) to start of study follow-up; add this number of days to matched control patient's most recent FAP-related surgery date=index date for Matched Control.
  
  
• Time From Start of Study Follow-up to the Time of First Excisional Polypectomy of a Rectal Polyp Post IRA [ Time Frame: Baseline, Up to 60 months post-baseline ] [ Designated as safety issue: No ]
  Time(months): [date of first excisional polypectomy of rectal polyp post IRA minus date of start of study follow-up plus 1] divided by 30.44.
  
  
• Time From Ileopouch Anal Anastomosis (IPAA) to Time of First Excisional Polypectomy of a Rectal Polyp Post IPAA [ Time Frame: Up to 15 years prior to baseline ] [ Designated as safety issue: No ]
  Time (months): [date of first excisional polypectomy of a rectal polyp post IPAA minus date of prior IPAA plus 1] divided by 30.44. Baseline = start of study follow-up: start of on-study celecoxib treatment period for celecoxib-treated subjects and comparable to index date for control subjects. Index date calculated as Matched Celecoxib-treated patients: number of days from most recent FAP-related surgery (IRA or IPAA) to start of study follow-up; add this number of days to matched control patient's most recent FAP-related surgery date=index date for Matched Control.
  
  
• Time From Start of Study Follow-up to Time of First Excisional Polypectomy of a Rectal Polyp Post IPAA [ Time Frame: Baseline, Up to 60 months post-baseline ] [ Designated as safety issue: No ]
  Time (months): [date of first excisional polypectomy of rectal polyp post IPAA minus date of start of study follow-up plus 1] divided by 30.44.
  
  

• Time From Most Recent Prior FAP-related Surgical Event or Onset of FAP Phenotype to Time of First Excisional or Ablational Event for Rectal, Colonic, Pouch, or Duodenal Adenomas (Duodenal Adenomatous Polyps) [ Time Frame: Up to 15 years prior to baseline ] [ Designated as safety issue: No ]
  Time (months): [date of first excisional or ablational event for colonic, pouch, or duodenal adenomas occuring after date of most recent prior FAP-related surgical event or date of FAP diagnosis minus date of most recent prior FAP-related surgical event or date of FAP diagnosis plus 1] divided by 30.44.
  
  
• Time From Start of Study Follow-up to Time of First Excisional or Ablational Event for Rectal, Colonic, Pouch, or Duodenal Adenomas [ Time Frame: Baseline, Up to 60 months post-baseline ] [ Designated as safety issue: No ]
  Time (months): [date of first excisional or ablational event for colonic, pouch, or duodenal adenomas, occurring after date of most recent prior FAP-related surgical event, or date of FAP diagnosis minus date of start of study follow-up plus 1] divided by 30.44.
  
  
• Time From Most Recent Prior FAP-related Surgical Event or Onset of FAP Phenotype to Time of First FAP-related Adverse Event [ Time Frame: Up to 15 years prior to baseline ] [ Designated as safety issue: No ]
  Time (months): [date of first FAP-related adverse event, occurring after the date of most recent prior FAP-related surgery, or date of FAP diagnosis minus date of most recent prior FAP-related surgery, or date of FAP diagnosis plus 1] divided by 30.44. FAP-related adverse event defined as any FAP related cancers, desmoid tumors requiring procedural intervention, hospitalizations or procedural interventions, or death related to FAP (i.e., as a consequence of FAP, FAP complications, or a procedure or drug used to treat FAP-related medical problems).
  
  
• Time From Start of Study Follow-up to Time of First FAP-related Adverse Event [ Time Frame: Baseline, Up to 60 months post-baseline ] [ Designated as safety issue: No ]
  Time (months): [date of first FAP-related adverse event, occurring after the date of the most recent prior FAP-related surgery, or date of FAP diagnosis minus date of start of study follow-up plus 1] divided by 30.44. FAP-related adverse event defined as any FAP related cancers, desmoid tumors requiring procedural intervention, hospitalizations or procedural interventions, or death related to FAP (i.e., as a consequence of FAP, FAP complications, or a procedure or drug used to treat FAP-related medical problems).
  
  
• Time From Post IRA to Time of Conversion From IRA to IPAA [ Time Frame: Up to 15 years prior to baseline ] [ Designated as safety issue: No ]
  Time (months): [date of IPAA minus date of prior IRA plus 1] divided by 30.44.
  
  
• Time From Start of Study Follow-up to Time of Conversion From IRA to IPAA [ Time Frame: Baseline, Up to 60 months post-baseline ] [ Designated as safety issue: No ]
  Time (months): [date of IPAA minus date of start of study follow-up plus 1] divided by 30.44.
  
  
• Duodenal Adenoma Burden as Measured by Spigelman Stage [ Time Frame: Baseline, 6 to 14 months post-baseline, End of study (EOS) ] [ Designated as safety issue: No ]
  Number of subjects with polyp burden as assessed in most recent prior polyps evaluation: Spigelman stage provides index of disease severity based on number of polyps, polyp size, histology, and dysplasia; range is Stage 0 (none) to Stage IV (severe). EOS: endoscopic examination closest to end of on-study celecoxib or index period (within 6 months of end of celecoxib or index period and prior to intake of any exclusionary medications after baseline). Spigelman Stage not completed as staging data largely missing; see measure: Duodenal adenoma burden as measured by polyp counts.
  
  
• Rectal or Pouch Adenoma Burden Based on Polyp Counts [ Time Frame: Baseline, 6 to 14 months post-baseline, EOS ] [ Designated as safety issue: No ]
  Number of subjects with polyp burden as assessed in most recent prior polyps evaluation: attenuated: <100 polyps, mild: between 100 to 1000 polyps, severe: >1000 polyps. EOS: endoscopic examination closest to end of on-study celecoxib or index period (within 6 months of end of celecoxib or index period and prior to intake of any exclusionary medications after baseline).
  
  

The study prematurely discontinued on April 11, 2008 due to slow enrollment. It should be noted that safety concerns have not been seen in this study and have not factored into this decision.