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Prevention of progression of duodenal adenomas to cancer in patients with familial adenomatous polyposis - Duodenal adenomas and cancer in patients with FAP

Prevention of progression of duodenal adenomas to cancer in patients with familial adenomatous polyposis - Duodenal adenomas and cancer in patients with FAP

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2008-003696-43-NL
Enrollment
Unknown
Registered
2008-11-11
Start date
2008-11-25
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Familial Adenomatous Polyposis Duodenal adenomas and carcinomas

Interventions

Trade Name: Celebrex Product Name: Celecoxib Product Code: M01AH01 Pharmaceutical Form: Capsule, hard INN or Proposed INN: celecoxib CAS Number: 169590-42-5 Concentration unit: mg milligram(s) Concent

Sponsors

KWF Kankerbestrijding
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with FAP with duodenal adenomas Spigelman stage II and III, under regular controle in one of 4 participating University hospitals. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - History of cardiovascular incident - Cholelithiasis - History of gastric or duodenal ulcera - Allergic reaction to NSAIDs or UDCA - Renal function disturbance, creat clearance or = 10 - Use of NSAIDs or UDCA during enrolment - Cardiac patients NYHA class II-IV - Age below 18 or above 70 years or incapable of signing informed consent

Design outcomes

Primary

MeasureTime frame
Main Objective: This is an intervention study on the chemoprevention of duodenal adenomas in patients with Familial Adenomatous Polyposis (FAP). In addition, mucosal- as well as tissue factors that may contribute to the development of duodenal adenomas and carcinomas in patients with FAP will be investigated. The relevance of this study is twofold; patients with FAP are at high risk for developing duodenal carcinoma. Better insights in the pathogenesis of duodenal cancer and development of chemoprevention strategies are of pivotal importance. Secondly, mutations in the APC gene, reponsible for the the phenotype of FAP, also occur in patients with sporadic colorectal carcinoma, and therefore studies on the interactions of intestinal contents and mucosal cell homeostasis may yield new insights with respect to both FAP and non-FAP related gastrointestinal cancers. ;Secondary Objective: ;Primary end point(s): Number and size of duodenal adenomas—

Countries

Netherlands

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026