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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Observational

Official Title: A Registry-Based Observational Study Assessing Clinical Outcomes In Familial Adenomatous Polyposis In Patients Receiving Celecoxib (Celebrex(Registered), Onsenal(Registere

Brief Summary:

This is a registry-based observational study assessing clinical outcomes in FAP patients receiving celecoxib compared with historical/concurrent registry patients who have not received celecoxib.

Both retrospective and prospective data will be utilized. No sampling methods apply.


Detailed Summary: September 7, 2005
Sponsor: Pfizer

Current Primary Outcome:

  • 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 ]
    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 ]
    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 ]
    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

    Original Primary Outcome:

    Current Secondary Outcome:

    • 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 ]
      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 ]
      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 ]
      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 ]
      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 ]
      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 ]
      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) ]
      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 ]
      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).


    Original Secondary Outcome:

    Information By: Pfizer

    Dates:
    Date Received: September 7, 2005
    Date Started: November 2004
    Date Completion:
    Last Updated: March 4, 2010
    Last Verified: March 2010