PHASE II CLINICAL TRIAL OF CELECOXIB IN PERSONS WITH GE

家族性腺瘤性息肉病(FAP)是一种遗传性的弥漫性结肠腺瘤和结直肠癌的易感性，几乎100%发生在未切除的结肠中，由APC基因的胚系突变引起。大多数患FAP的受试者在10岁到15岁之间表现出早期腺瘤的证据。突变的APC基因也易患十二指肠息肉和壶腹周围癌。尽管诊断时的护理标准一直被认为是结肠切除术，但从业者和患者越来越愿意接受监测，直到有证据表明息肉负担逐渐加重。最近的一项试验表明，塞来昔布在FAP晚期腺瘤性疾病患者的常见腺瘤消退中具有活性。这项研究将研究年轻的、无症状的APC突变携带者的结直肠粘膜的自然病史，并探索塞来昔布在抑制腺瘤表型出现方面的作用。此外，一些辅助评估将检查这种潜在的预防方法对患者心理社会状况的相对影响。

Familial adenomatous polyposis (FAP) is an inherited susceptibility to diffuse colorectal adenomas and to colorectal carcinoma, occurring in close to 100% of unresected colons and is caused by a germline mutation in the APC gene. Most subjects who develop FAP show evidence of early adenomas between ages 10 and 15. The mutated APC gene also predisposes to duodenal polyps and to periampullary carcinoma. Although the standard of care has long been considered to be colectomy at diagnosis, practitioners and patients have been increasingly willing to undergo surveillance until there is evidence of progressive polyp burden. A recent trial demonstrated the activity of celecoxib in regressing prevalent adenomas in FAP patients with advanced adenomatous disease. This study will examine the natural history of the colorectal mucosa in young, asymptomatic carriers of APC mutations, and explore the role of celecoxib in suppressing emergence of the adenomatous phenotype. In addition, a number of ancillary evaluations will examine the relative impact of this potential preventive approach on the psychosocial status of patients.