Neoplasms

Digestive System Diseases

Diseases and Abnormalities at or Before Birth

All Conditions

Symptoms and General Pathology

Rare Diseases

Adenomatous Polyposis Coli

Inflammatory Bowel Diseases

Intestinal Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Gastroenteritis

Polyps

Adenomatous Polyps

Adenoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Syndrome

Neoplastic Syndromes, Hereditary

Intestinal Polyposis

Genetic Diseases, Inborn

Familial Adenomatous Polyposis

MYH-associated Polyposis

Confocal endomicroscopy

The principle objective of this study is to validate confocal endomicroscopy (CEM) in a national, multicenter study, in terms of its ability to diagnose neoplastic lesions in vivo, in two groups of patients at high risk of colorectal cancer (CRC): patients with familial adenomatous polyposis (FAP) after colectomy in whom the neoplastic lesions are probably under-diagnosed, and patients with inflammatory bowel diseases (IBD) in whom endoscopic surveillance is particularly difficult. Methods: The study will be comprised of two phases (Phase I and II). Phase I will serve to validate at the multicenter level the results of the first, recently published, monocenter German study in terms of capacity of CEM to identify the colonic neoplastic lesions in vivo. Phase II is destined to prospectively evaluate the diagnostic yield of CEM in detection and prediction of neoplastic lesions by developing and adding new features to the confocal pattern of in vivo diagnosis. Two cohorts of patients will be studied in parallel: Patients with inflammatory bowel diseases (IBD), like ulcerative colitis (UC) or Crohn's disease (CD), including those before planned colectomy, and patients with FAP after colectomy. During lower endoscopy performed under general anaesthesia, each colonic segment will be examined before and after staining with indigo-carmin. After intra-venous fluorescein injection, all macroscopically abnormal lesions will be examined by CEM, then biopsied. In parallel, multiple random biopsies will be performed, each coupled with simultaneous CEM "optical biopsy" at the same point. In addition, during Phase II, in IBD patients before planned colectomy and in patients with FAP, a "mapping" of colonic mucosa, by obtaining a very high number of CEM "optical biopsies", will be performed, and will be correlated with standard histology performed either on colectomy specimens (IBD) or on standard biopsies (FAP). Principal analysis (Phase I and II) will include evaluation of inter-observer variation in terms of interpretation of in vivo histology and diagnostic yield of CEM with respect to the detection of neoplastic lesions by evaluation of sensitivity and specificity, using standard histology as reference method. Additional analysis (Phase II) will be performed to evaluate the diagnostic and predictive (CRC risk) value of "colonic mapping" by correlating optical images pattern score to results of standard histology. Expected results: This study should guarantee high quality data, standardization of procedures and of interpretation of CEM images, which are prerequisite for dissemination of CEM in clinical practice. The investigators expect to show that CME allows to reliably discriminate between neoplastic and non-neoplastic lesions, that, compared to standard histology, provides better characterization of lesions, especially in the context of extended lesions like in IBD, an finally, that CME images can be used to develop a new "optical biopsy"-based score allowing prediction of high CRC risk in patients with FAP and IBD. The investigators believe that CEM may increase, as compared to currently used techniques, the diagnostic yield in terms of probability of the detection of neoplastic lesions in patients at high risk of CCR, and may become a new standard for endoscopic surveillance in these patients.

Endomicrocancer: Confocal Endomicroscopy in Patients With High Risk of Colorectal Cancer

Confocal Endomicroscopy in Patients With High Risk of Colorectal Cancer: Potential for Diagnosis of Early Neoplasia

Nantes University Hospital

Pr Jean Paul Galmiche

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Nasopharyngeal Neoplasms

Rectal Diseases

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Head and Neck Neoplasms

Nasopharyngeal Diseases

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

Anti-Inflammatory Agents

Antineoplastic Agents

Antirheumatic Agents

Analgesics

All Drugs and Chemicals

Herbal and Botanical

Curcumin

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Enzyme Inhibitors

Cola

Patients will be randomized to curcumin (3 curcumin pills twice a day for 12 months).

Calcumin (Curcumin)

Questions about current and past lifestyle, health background, and medications. This will take about 20 minutes.

Risk Factor Questionnaire

Three tubes of blood at visits 0, 4 and 12 months.

Blood samples

Flexible sigmoidoscopy at baseline and every 4 months for the length of the study (4 months, 8 months, 12 months and 16 months). We will take 2-4 tissue samples of the colon lining by a pinch biopsy.

Biopsies (Sigmoidoscopy)

Other: Biopsies (Upper endoscopy) Upper endoscopy at baseline and at 12 months. We will take 2-4 tissue samples of the small intestine lining by a pinch biopsy.

Biopsies (Upper endoscopy)

Marcia R. Cruz-Correa, MD. PhD

Familial Adenomatous Polyposis (FAP) is an autosomal dominant disorder characterized by the formation of multiple adenomatous colorectal polyps usually in the teenage years. Virtually, all patients with FAP will develop colorectal cancer on average by the 5th decade of life if prophylactic surgery is not performed. Besides, these individuals must have lifelong cancer surveillance of the remaining colorectum or ileum.

Use of nonsteroidal anti-inflammatory drug (NSAID), such as sulindac, or celecoxib, which selectively inhibits prostaglandin synthesis primarily via the inhibition of cyclogenase-2 (COX-2) have been shown to reduce the incidence and induce regression of adenomas in the rectum of patients with FAP. However, use of NSAIDs and COX-2 inhibitors is associated with significant comorbidity including renal and gastric toxicity and increased risk of vascular events. Therefore, identification of a chemopreventive agent that would have similar efficacy but less toxicity would enhance our ability to treat these patients. Therefore the following specific aim has been proposed:To determine in a randomized, double-blinded, placebo-controlled study the tolerability and efficacy of curcumin to regress intestinal adenomas by measuring duodenal and colorectal/ileal polyp number, and polyp size in patients with FAP.

Patients will be randomized to curcumin (2 curcumin pills twice a day for 12 months) or placebo (2 pills twice a day for 12 months). Besides, blood samples, risk factor questionnaire,and biopsies (upper endoscopy and sigmoidoscopy) will be obtained.

Use of Curcumin for Treatment of Intestinal Adenomas in Familial Adenomatous Polyposis (FAP)

To determine in a randomized, double-blinded, placebo-controlled study the tolerability and efficacy of curcumin to regress intestinal adenomas by measuring duodenal and colorectal/ileal polyp number in patients with FAP.

To determine in a randomized, double-blinded, placebo-controlled study the tolerability and efficacy of curcumin to regress intestinal adenomas by measuring duodenal and colorectal/ileal polyp size in patients with FAP.

National Institutes of Health (NIH)

University of Puerto Rico

Director of Gastrointestinal Oncology

Curcumin

Calcumin (Curcumin): Patients will be randomized to curcumin (3 curcumin pills twice a day for 12 months).

Risk Factor Questionnaire: Questions about current and past lifestyle, health background, and medications. This will take about 20 minutes.

Blood samples: Three tubes of blood at visits 0, 4 and 12 months.

Biopsies (Sigmoidoscopy): Flexible sigmoidoscopy at baseline and every 4 months for the length of the study (4 months, 8 months, 12 months and 16 months). We will take 2-4 tissue samples of the colon lining by a pinch biopsy.

Biopsies (Upper endoscopy): Other: Biopsies (Upper endoscopy) Upper endoscopy at baseline and at 12 months. We will take 2-4 tissue samples of the small intestine lining by a pinch biopsy.

Placebo (sugar pills)

Calcumin (Curcumin): Patients will be randomized to curcumin (3 curcumin pills twice a day for 12 months).

Risk Factor Questionnaire: Questions about current and past lifestyle, health background, and medications. This will take about 20 minutes.

Blood samples: Three tubes of blood at visits 0, 4 and 12 months.

Biopsies (Sigmoidoscopy): Flexible sigmoidoscopy at baseline and every 4 months for the length of the study (4 months, 8 months, 12 months and 16 months). We will take 2-4 tissue samples of the colon lining by a pinch biopsy.

Biopsies (Upper endoscopy): Other: Biopsies (Upper endoscopy) Upper endoscopy at baseline and at 12 months. We will take 2-4 tissue samples of the small intestine lining by a pinch biopsy.

Placebo

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Puerto Rico

Region of Enrollment

Dr. Marcia Cruz-Correa

Number of Polyps

Size of Polyps

Overall Study

Inflammation

FAP patients who underwent prophylactic total colectomy

FAP individuals followed for 3 months a low-inflammatory diet

Anti-inflammatory Diet

Marco Vitellaro, MD

Preventive anti-inflammatory diet to reduce gastro-intestinal inflammation in FAP patients: a prospective pilot study

Preventive Anti-inflammatory Diet to Reduce Gastro-intestinal Inflammation in FAP Patients: a Prospective Pilot Study

Change from baseline in calprotectin levels at 3 months and 6 months post anti-inflammatory diet consumption.

Change from baseline in circulatory inflammatory markers at 3 months and 6 months post anti-inflammatory diet consumption.

Evaluate the effect of the anti-inflammatory diet on polyps growth in the rectal stump (in terms of number of polyps)

Change from baseline in the number of diarrheal discharges at 3 months and 6 months post anti-inflammatory diet consumption

Change from baseline in the immune cell profile at 3 months and 6 months post anti-inflammatory diet consumption

Change from baseline in stool inflammatory markers at 3 months and 6 months post anti-inflammatory diet consumption

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Anti-Infective Agents

Gastrointestinal Agents

Erythromycin

Erythromycin Estolate

Erythromycin Ethylsuccinate

Erythromycin stearate

Anti-Bacterial Agents

Oral treatment with Erythromycin 250-500mg (will be determined according to body weight) twice a day.

Oral Treatment with Erythromycin 250-500mg, twice daily, for 16 weeks.Exact dose is subjected to body weight and will be determined by the study's pediatrician.

Reut Elya, Ms.C

Sivan Aharon Kaspi, Bs.C

Revital Kariv, MD

Rina Rosin-Arbeseld, Ph.D

Colorectal cancer (CRC) is a leading cause for cancer related mortality in the western world with a lifetime risk of 6%. Etiology is complex, while genetic background significantly affects the risk. Around one third of all genetic disorders as well as most cases of Familial Adenomatous Polyposis (FAP) and a large proportion of all sporadic CRC cases occur as a result of premature nonsense mutations (creating a stop codon) in an individual's adenomatous polyposis coli (APC) gene. Nonsense mutations are single-point alterations in the DNA that prematurely halt the protein translation process, producing a shortened, nonfunctional protein. In many of these cases, if the cell can be 'persuaded' to ignore the premature stop codon signal, the resulting protein may be able to ameliorate or stop the disease.

Recently, members of the aminoglycoside family of antibiotics have been found to induce ribosomal read-through of nonsense mutations, leading to expression of a full length, functional protein. Investigators have recently shown that members of the aminoglycoside and macrolide antibiotic families can induce read-through of the nonsense mutations in the APC gene and lead to reduced oncogenic phenotypes in CRC cells and in different mice models.

The aim of this project is to determine the ability of the macrolide antibiotic-erythromycin to induce read-through of the nonsense mutations in the APC gene and to induce expression of a full length, functional APC protein in patients suffering from FAP and to tests its effect on adenoma number and size and on desmoid tumors in these patients. The future goal is to maximize the effect of stop-codon suppressors on APC while minimizing side effects.

In this study investigators will select FAP patients which carry APC nonsense mutations, treat them with erythromycin PO for 4-6 months and examine colonic and duodenal adenomas as well as abdominal desmoid tumors, that will be documented before during and after treatment. In parallel, investigators will test polyp, adenoma and desmoid tissue samples as well as blood samples from these patients for changes in expression levels of the APC protein and related oncogenic markers.

Suppression of nonsense mutations within the APC gene should be of benefit for patients suffering from FAP, attenuated FAP or multiple adenomas and for patients with advanced or diffuse CRC. Furthermore, given the rapid progress being made in the identification of different nonsense mutations in human genes that lead to mostly un-curable disease, the identification of clinically approved compounds that suppress nonsense mutations and that can be administered long-term without significant side effects would open new venues in the treatment of genetic human diseases that arise from pre-mature stop codons in important coding sequences.

Immediate goal: establish the ability of erythromycin to read-through APC nonsense mutation in FAP patients. The read-through effect of erythromycin will be clinically tested by counting and measuring the number and size of both colonic and duodenal adenomas before and over treatment and by measuring the size of known desmoid tumors. Samples of the adenomas and desmoid tumors will be tested by western blot, immunofluorescence and immunohistochemistry for restoration of APC expression and changes in oncogenic markers. These experiments should be conducted within 6 month.

Long term objective:

1. Determine the lowest dose of erythromycin that can inhibit growth of colonic neoplasia and CRC in patients expressing a truncated APC protein due to nonsense mutations.
2. Examine the ability of a panel of additional macrolide antibiotics to induce APC nonsense mutation suppression using in-vitro methods. Investigators will focus on macrolide antibiotics that are currently in clinical use and are administrated for long terms. These objectives should take around 6 month and will be conducted in parallel.

Erythromycin Treatment for Readthrough of APC Gene Stop Codon Mutation in Familial Adenomatous Polyposis-minors' Adjusted Version

Erythromycin Treatment for Readthrough of APC Gene Stop Codon Mutation in Familial Adenomatous Polyposis-protocol is Identical to Study No. 0519-10-TLV- Minors' Adjusted Version

Change in number of adenomas from baseline will be measured by endoscopic and histological evaluation. response will be tested by upper and lower endoscopies after 8 ,16-20 weeks and 12 months of treatment.

Desmoids imaging (US or CT or MRI) will be performed to determine the size at the begining of the study and to evaluate the change from baseline after 4-6 months of treatment.

michal roll

director, R&D Division

Celecoxib

Cyclooxygenase 2 Inhibitors

Cyclooxygenase Inhibitors

Observation of subjects treated with routine medical care

Routine Medical Care

Pfizer CT.gov Call Center

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.

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.

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

A Registry-Based Observational Study Assessing Clinical Outcomes In Familial Adenomatous Polyposis In Patients Receiving Celecoxib (Celebrex(Registered), Onsenal(Registered)) Compared With Control Patients

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(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 (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 (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 (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 (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 (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 (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 (months): \[date of IPAA minus date of prior IRA plus 1\] divided by 30.44.

Time (months): \[date of IPAA minus date of start of study follow-up plus 1\] divided by 30.44.

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.

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).

Pfizer

Director, Clinical Trial Disclosure Group

All SAEs, expected and unexpected, occurring while subject was receiving celecoxib during his/her prospective (on-study) participation in the study, regardless of the apparent relationship to the drug, were collected and reported to the sponsor. Not applicable to Matched Control subjects n=13; SAEs not collected if no celecoxib treatment received.

All celecoxib treated subjects (includes Matched Celecoxib Treated and Not Matched Celecoxib Treated subjects); treatment prescribed outside clinical trial setting per routine medical care. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.

All Celecoxib Treated

Celecoxib treatment prescribed outside clinical trial setting per routine medical care; matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.

Matched Celecoxib Treated

Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: all patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.

Matched Control

Celecoxib treatment prescribed outside clinical trial setting per routine medical care; not matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.

Not Matched Celecoxib Treated

<25 years

25 to 34 years

35 to 44 years

45 to 54 years

55 to 64 years

>64 years

Age not available (no surgery)

Age range groups at most recent FAP-related surgery (years). Prior to start of study follow-up = prior to baseline. Start of study follow-up: start of on-study celecoxib treatment period for celecoxib-treated subjects and index date for control subjects = baseline.

Age, Customized

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.

Pfizer ClinicalTrials.gov Call Center

Time to FAP-related surgical events (months); twenty-fifth (25th) percentile presented due to limited number of subjects.

Index date based on most recent colon and or rectum adenomatous polyps evaluation, most recent duodenal adenomatous polyps evaluation, and most recent desmoids tumors evaluation for Matched Control, Not Matched Celecoxib, and All Celecoxib Treated, respectively.

Only 13 matched pairs identified: p-values not computed in analysis of time-to-event endpoints

Time to FAP-related surgical events (months); 25th percentile.

Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.

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.

Time From Ileorectal Anastomosis (IRA) to Time of First Excisional Polypectomy of a Rectal Polyp Post IRA

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).

Time From Start of Study Follow-up to the Time of First Excisional Polypectomy of a Rectal Polyp Post IRA

Time to FAP-related surgical events (months); 25th percentile. Index date based on most recent colon and or rectum adenomatous polyps evaluation, most recent duodenal adenomatous polyps evaluation, and most recent desmoids tumors evaluation for Matched Control, Not Matched Celecoxib, and All Celecoxib Treated, respectively.

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).

Time From Ileopouch Anal Anastomosis (IPAA) to Time of First Excisional Polypectomy of a Rectal Polyp Post IPAA

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).

Time From Start of Study Follow-up to Time of First Excisional Polypectomy of a Rectal Polyp Post IPAA

All eligible subjects; first excisional or ablational event for rectal adenomas that does not qualify for primary efficacy endpoint; after most recent FAP-related surgical event prior to start of study follow-up or onset of FAP phenotype for subjects with no prior FAP-related surgery.

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)

All eligible subjects included, except left censored subjects (had any excisional or ablational event for rectal, colonic, pouch, or duodenal adenomas between date of most recent FAP-related surgical event performed prior to the start of study follow-up, or onset of FAP phenotype \[with no prior FAP-related surgery\], and start of study follow-up).

Time From Start of Study Follow-up to Time of First Excisional or Ablational Event for Rectal, Colonic, Pouch, or Duodenal Adenomas

Time to FAP-related events (months); 25th percentile.

All eligible subjects; first FAP-related adverse event (FAP-related cancers, desmoid tumors requiring procedural intervention, hospitalizations, procedural interventions, or death related to FAP) after subject's most recent FAP-related surgical event performed prior to start of study follow-up, onset of FAP phenotype (no prior FAP-related surgery).

Time From Most Recent Prior FAP-related Surgical Event or Onset of FAP Phenotype to Time of First FAP-related Adverse Event

All eligible subjects included, except left-censored subjects (had any FAP-related adverse event between the date of most recent FAP-related surgical event performed prior to start of study follow-up, or onset of FAP phenotype (no prior FAP-related surgery), and start of study follow-up.

Time From Start of Study Follow-up to Time of First FAP-related Adverse Event

All eligible subjects with IRA performed prior to start of study follow-up; data censored (n=5) for control group subjects (no data).

Time From Post IRA to Time of Conversion From IRA to IPAA

All eligible subjects with IRA performed prior to start of study follow-up included, except left-censored subjects (had IPAA prior to start of study follow-up); data censored (n=5) for control group subjects (no data).

Time From Start of Study Follow-up to Time of Conversion From IRA to IPAA

Baseline attenuated

Baseline mild

Baseline severe

Baseline unknown

Baseline no polyps

Baseline not assessed

Post-baseline attenuated

Post-baseline mild

Post-baseline severe

Post-baseline unknown

Post-baseline no polyps

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). Post-hoc analysis of duodenal polyp burden in terms of severity categories and based on polyp numbers; Spigelman Stage not completed as staging data largely missing (see: Duodenal adenoma burden as measured by Spigelman Stage)

All subjects; Spigelman Stage not completed as staging data largely missing; duodenal polyp burden analyzed in terms of severity categories and based on polyp numbers.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Endomicrocancer: Confocal Endomicroscopy in Patients With High Risk of Colorectal Cancer	NCT01052376	Inflammatory Bo... Familial Adenom...	Confocal endomi...	18 Years - 75 Years	Nantes University Hospital
Use of Curcumin for Treatment of Intestinal Adenomas in Familial Adenomatous Polyposis (FAP)	NCT00927485	Familial Adenom...	Calcumin (Curcu... Risk Factor Que... Blood samples Biopsies (Sigmo... Biopsies (Upper...	21 Years - 85 Years	University of Puerto Rico
Preventive Anti-inflammatory Diet to Reduce Gastro-intestinal Inflammation in FAP Patients: a Prospective Pilot Study	NCT04552405	Familial Adenom...	Anti-inflammato...	18 Years -	Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Erythromycin Treatment for Readthrough of APC Gene Stop Codon Mutation in Familial Adenomatous Polyposis-minors' Adjusted Version	NCT02354560	FAP-Familial Ad...	Erythromycin	10 Years - 17 Years	Tel-Aviv Sourasky Medical Center
Preventive Anti-inflammatory Diet to Reduce Gastro-intestinal Inflammation in FAP Patients: a Prospective Pilot Study	NCT04552405	Familial Adenom...	Anti-inflammato...	18 Years -	Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Observational Familial Adenomatous Polyposis Registry Study In Patients Receiving Celecoxib Compared to Control Patients	NCT00151476	Familial Adenom...	Celecoxib Routine Medical...	12 Years -	Pfizer

Spots Global Cancer Trial Database for familial adenomatous polyposis (fap)