Familial Adenomatous Polyposis (FAP) Clinical Trial
Official title:
A Registry-Based Observational Study Assessing Clinical Outcomes In Familial Adenomatous Polyposis In Patients Receiving Celecoxib (Celebrex(Registered), Onsenal(Registered)) Compared With Control Patients
| Verified date | March 2010 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Observational |
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.
| Status | Terminated |
| Enrollment | 68 |
| Est. completion date | November 2008 |
| Est. primary completion date | November 2008 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 12 Years and older |
| Eligibility |
Inclusion Criteria: Celecoxib Treated Patients: - Diagnosis of FAP based on the expression of the FAP phenotype. - Celecoxib treatment prescribed outside of a clinical trial setting with expected duration of celecoxib treatment of at least six months. Historical/Concurrent Control Patients: - Diagnosis of FAP based on the expression of the FAP phenotype. - Be greater than or equal to 12 years old at the time of study enrollment. - Have an endoscopically assessable colonic, rectal, ileal pouch and/or gastroduodenal segment. - For the group of post-surgical patients, IRA or IPAA performed from 1985 onward (in order to assure standardized surgical techniques and post-surgical management). Patients whose primary colorectal surgery was performed prior to 1985 will not be eligible to serve as historical controls. Exclusion Criteria: Celecoxib Treated Patients: - Have received a pharmacological treatment (other than celecoxib) within the last 3 months for their FAP disease including treatment of any extracolonic manifestation of FAP. - Have received a non-steroidal anti-inflammatory drug (NSAID) within the last 3 months, other than celecoxib, for any reason. Historical/Concurrent Control Patients: - Have pharmacological treatment recorded for their FAP disease at the defined index date. - Have received a non-steroidal anti-inflammatory drug (NSAID) within the last 3 months for any reason. |
Observational Model: Cohort
| Country | Name | City | State |
|---|---|---|---|
| Canada | Pfizer Investigational Site | Toronto | Ontario |
| Denmark | Pfizer Investigational Site | Hvidovre | Copenhagen |
| Spain | Pfizer Investigational Site | Barcelona | |
| United States | Pfizer Investigational Site | Cleveland | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
United States, Canada, Denmark, Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Time From Ileorectal Anastomosis (IRA) to Time of First Excisional Polypectomy of a Rectal Polyp Post IRA | 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. | Up to 8 years prior to baseline | No |
| Primary | Time From Start of Study Follow-up to the Time of First Excisional Polypectomy of a Rectal Polyp Post IRA | 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. | Baseline, Up to 60 months post-baseline | No |
| Primary | Time From Ileopouch Anal Anastomosis (IPAA) to Time of First Excisional Polypectomy of a Rectal Polyp Post IPAA | 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. | Up to 15 years prior to baseline | No |
| Primary | Time From Start of Study Follow-up to Time of First Excisional Polypectomy of a Rectal Polyp Post IPAA | 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. | Baseline, Up to 60 months post-baseline | No |
| Secondary | 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 (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. | Up to 15 years prior to baseline | No |
| Secondary | Time From Start of Study Follow-up to Time of First Excisional or Ablational Event for Rectal, Colonic, Pouch, or Duodenal Adenomas | 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. | Baseline, Up to 60 months post-baseline | No |
| Secondary | Time From Most Recent Prior FAP-related Surgical Event or Onset of FAP Phenotype to Time of First FAP-related Adverse Event | 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). | Up to 15 years prior to baseline | No |
| Secondary | Time From Start of Study Follow-up to Time of First FAP-related Adverse Event | 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). | Baseline, Up to 60 months post-baseline | No |
| Secondary | Time From Post IRA to Time of Conversion From IRA to IPAA | Time (months): [date of IPAA minus date of prior IRA plus 1] divided by 30.44. | Up to 15 years prior to baseline | No |
| Secondary | Time From Start of Study Follow-up to Time of Conversion From IRA to IPAA | Time (months): [date of IPAA minus date of start of study follow-up plus 1] divided by 30.44. | Baseline, Up to 60 months post-baseline | No |
| Secondary | Duodenal Adenoma Burden as Measured by Spigelman Stage | 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. | Baseline, 6 to 14 months post-baseline, End of study (EOS) | No |
| Secondary | Rectal or Pouch Adenoma Burden Based on Polyp Counts | 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). | Baseline, 6 to 14 months post-baseline, EOS | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04552405 -
Preventive Anti-inflammatory Diet to Reduce Gastro-intestinal Inflammation in FAP Patients: a Prospective Pilot Study
|
N/A |