Familial Adenomatous Polyposis (FAP)NCT00151476

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

An observational study of Familial Adenomatous Polyposis (FAP), run by Pfizer at 4 sites in 4 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial 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. Read more about this study

Who is it for?: Ages 12 years and older
Conditions the study is for: Familial Adenomatous Polyposis (FAP)
What is being tested?: Celecoxib and Routine Medical Care
How many people: 68 participants
Where: 4 sitesin 4 countries
Study dates: Nov 2004to Nov 2008
Phase: Observational
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 12 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Patients with FAP

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

4 sites in 4 countries.

Country

City, postcode or hospital

4 sites in 4 countries

United States1 site

Pfizer Investigational Site
Cleveland, Ohio, 44195

Other trials in United States

Canada1 site

Pfizer Investigational Site
Toronto, Ontario, M5G1X5

Other trials in Canada

Denmark1 site

Pfizer Investigational Site
Hvidovre, Copenhagen, DK-2650

Other trials in Denmark

Spain1 site

Pfizer Investigational Site
Barcelona, 08036

Other trials in Spain

About this study

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

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.

Read the detailed description

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.

Conditions: Familial Adenomatous Polyposis (FAP)
Being tested: Celecoxib, Routine Medical Care
Keywords: Familial adenomatous polyposis, celecoxib, IRA, IPAA
Medical subject headings: Adenomatous Polyposis Coli

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CelecoxibDrug
Also called celebrex, SC-58635
800 mg total daily dosing
Routine Medical CareOther

Study groups in NCT00151476
Study group	Role	What they receive
Celecoxib - Routine Medical Care		800 mg total daily dosing Receives: Drug: Celecoxib
Control Group - Routine Medical Care		Observation of subjects treated with routine medical care Receives: Other: Routine Medical Care

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Up to 8 years prior to baseline
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.
Measured: Baseline, Up to 60 months post-baseline
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.
Measured: Up to 15 years prior to baseline
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.
Measured: Baseline, Up to 60 months post-baseline

Secondary outcomes (8)

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.
Measured: Up to 15 years prior to baseline
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.
Measured: Baseline, Up to 60 months post-baseline
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).
Measured: Up to 15 years prior to baseline
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).
Measured: Baseline, Up to 60 months post-baseline
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.
Measured: Up to 15 years prior to baseline
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.
Measured: Baseline, Up to 60 months post-baseline
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.
Measured: Baseline, 6 to 14 months post-baseline, End of study (EOS)
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).
Measured: Baseline, 6 to 14 months post-baseline, EOS

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2004Nov 2008

First posted9 Sep 2005 (estimated)
Study startNov 2004
Primary completionNov 2008
Study completionNov 2008

Why it stopped: See Detailed Description

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.
Other trials for Familial Adenomatous Polyposis (FAP)Studies of the same condition, open and under way.
More trials run by PfizerThe 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: Observational
Observational model: Cohort
Time perspective: Other
Enrolment: 68 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00151476
Sponsor's protocol ID: NQ4-00-02-012
Other IDs: A3191167
Status last verified: Aug 2024
First submitted: 7 Sep 2005
Last updated: 4 Sep 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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RecruitingPhase 1/2
FOG-001 in Locally Advanced or Metastatic Solid Tumors
Cancer, Colorectal Cancer
Enrolling by invitation
Investigation of β-hydroxybutyrate Supplementation as Chemoprevention in Familial Adenomatous Polyposis
FAP, Familial Adenomatous Polyposis
RecruitingPhase 2
An Investigational Drug (TPST-1495) in Patients With Familial Adenomatous Polyposis
Colorectal Carcinoma, Familial Adenomatous Polyposis
Not yet recruitingPhase 1
A Safety Study of ST316 in Participants With Familial Adenomatous Polyposis (FAP).
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All Familial Adenomatous Polyposis (FAP) trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00151476
Acronym / sponsor ID: NQ4-00-02-012
Conditions: Familial Adenomatous Polyposis (FAP)
Keywords: Familial adenomatous polyposis, celecoxib, IRA, IPAA
Study type: Observational
Recruitment status: TerminatedReason stopped: See Detailed Description
Enrolment: 68 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Nov 2004
Primary completion: Nov 2008 (actual)
Study completion: Nov 2008 (actual)
First posted: 9 Sep 2005 (estimated)
Results: Posted 4 Mar 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 description

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.

Study design

Observational model: Cohort
Time perspective: Other
Number of arms: 2

Arm	Type	Receives
Celecoxib - Routine Medical Care	–	Drug: Celecoxib800 mg total daily dosing
Control Group - Routine Medical Care	–	Other: Routine Medical CareObservation of subjects treated with routine medical care

Who may qualify

Ages: 12 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Patients with FAP

Key inclusion criteria (8 listed)

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.
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.

Key exclusion criteria (6 listed)

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.
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.

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
CelecoxibAlso: celebrex, SC-58635800 mg total daily dosing	Drug	Celecoxib - Routine Medical Care
Routine Medical Care	Other	Control Group - Routine Medical Care

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 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
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.

8 secondary outcomes

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 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 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 From Start of Study Follow-up to Time of First FAP-related Adverse Event
Time frame: Baseline, Up to 60 months post-baseline
Time From Post IRA to Time of Conversion From IRA to IPAA
Time frame: Up to 15 years prior to baseline
Time From Start of Study Follow-up to Time of Conversion From IRA to IPAA
Time frame: Baseline, Up to 60 months post-baseline
Duodenal Adenoma Burden as Measured by Spigelman Stage
Time frame: Baseline, 6 to 14 months post-baseline, End of study (EOS)
Rectal or Pouch Adenoma Burden Based on Polyp Counts
Time frame: Baseline, 6 to 14 months post-baseline, EOS

Results and safety

Results posted to the registry on 4 Mar 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Matched Control	13	13
All Celecoxib Treated	55	54

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. Mean (Standard Deviation). Unit: months

Measure	Matched Celecoxib Treated n = 4	Matched Control n = 2	Not Matched Celecoxib Treated n = 26	All Celecoxib Treated n = 30
Value	86.4 (143.78)	4.0 (3.25)	78.4 (102.01)	79.5 (105.44)

Matched Celecoxib Treated: Kaplan-Meier Estimate of Time to Event: 14.49 (95% CI 3.48 to 301.64)
Not Matched Celecoxib Treated: Kaplan-Meier Estimate of Time to Event: 5.06 (95% CI 3.48 to 11.76)
All Celecoxib Treated: Kaplan-Meier Estimate of Time to Event: 5.52 (95% CI 3.48 to 14.49)

Population analysed: All eligible subjects with IRA performed prior to start of study follow-up; first excisional polypectomy of rectal polyp post IRA. Polyp size unavailable for many subjects; not considered in analysis.

Primary outcome: 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. Median (Full Range). Unit: months

Measure	Matched Celecoxib Treated n = 1	Matched Control n = 0	Not Matched Celecoxib Treated n = 5	All Celecoxib Treated n = 6
Value	19.8 (17.14)	–	32.1 (0.0 to 44.1)	25.9 (0.0 to 44.1)

Not Matched Celecoxib Treated: Kaplan-Meier Estimate of Time to Event: 5.98 (95% CI 0.00 to 33.77)
All Celecoxib Treated: Kaplan-Meier Estimate of Time to Event: 19.81 (95% CI 0.00 to 33.77)

Population analysed: All eligible subjects with IRA performed prior to start of study follow-up included, except left-censored subjects (had first excisional polypectomy of rectal polyp post IRA prior to start of study follow-up). No control group subjects (n=3) had a post-IRA polypectomy (no data).

Primary outcome: 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. Mean (Standard Deviation). Unit: months

Measure	Matched Celecoxib Treated n = 3	Matched Control n = 0	Not Matched Celecoxib Treated n = 0	All Celecoxib Treated n = 3
Value	152.7 (42.10)	–	–	152.7 (42.10)

Matched Celecoxib Treated: Kaplan-Meier Estimate of Time to Event: 137.34 (95% CI 104.73 to 183.48)
All Celecoxib Treated: Kaplan-Meier Estimate of Time to Event: 169.94 (95% CI 104.73 to 183.48)

Population analysed: All eligible subjects with IPAA performed prior to start of study follow-up included and with first excisional polypectomy of a rectal polyp post IPAA. No control group subjects (n=7) had a post-IPAA polypectomy (no data).

Primary outcome: 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. Mean (Standard Deviation). Unit: months

Measure	Matched Celecoxib Treated n = 3	Matched Control n = 0	Not Matched Celecoxib Treated n = 0	All Celecoxib Treated n = 3
Value	20.3 (15.72)	–	–	20.3 (15.72)

Matched Celecoxib Treated: Kaplan-Meier Estimate of Time to Event: 11.28 (95% CI 9.07 to 38.24)

Population analysed: All eligible subjects with IPAA performed prior to start of study follow-up included, except left-censored subjects (had first excisional polypectomy post IPAA prior to start of study follow-up). No control group subjects (n=7) had a post-IPAA polypectomy (no data).

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 15 years prior to baseline; up to 5 years post-baseline. No safety information actively searched for among celecoxib-treated subjects for retrospectively collected data (medical records); if serious adverse event (SAE) found, it was reported as SAE.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Celecoxib Treated	5 of 54 (9.3%)	0 of 54 (0%)	Not reported

Limitations and caveats (from the sponsor): Study prematurely discontinued May 2008 prior to reaching enrollment target; due to limited number of matched pairs, results do not provide sufficient data to evaluate effectiveness of celecoxib. Last subject last visit was November 2008.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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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.

Pfizer CT.gov Call Center study director

Pfizer

4 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Familial Adenomatous Polyposis (FAP), run by Pfizer at 4 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 6 exclusion criteria. 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: stopped early, as of the sponsor's last update on 4 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States, Canada, Denmark, Spain. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Mar 2010). 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?

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). The study lists 4 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 NCT00151476.

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 4 Sep 2024.