UCRC SPECIAL CASE STUDY PROTOCOL

本协议的目的是提供UCRC的机制，以更详细地评估患者的特征，这些患者似乎具有独特的疾病进程，已确定疾病的独特子集，对药物治疗的独特反应等。偶尔，UCRC被称为由教员关于患者或家庭谁似乎是独特的。 作为第一步，希望在受控环境中研究这些患者，例如UCRC提供的环境，严格控制饮食，定量收集尿液和粪便，并在常规或特殊实验室中连续采集血液进行各种测定。 偶尔，这些患者可以“适合”已经批准的方案，但如果他们不能，他们可以进入这个特殊的病例研究方案。 通过该方案，可以获得初步信息，如果确实显示患者具有独特的特征并需要进一步研究，则生成的数据可用于制定后续方案。 希望使用本方案的研究者必须向UCRC和IRB提交一份关于患者独特特征的简短书面描述，并说明拟议使用UCRC和要执行的程序的理由。 这必须附有同意书。 在开展研究之前，必须获得UCRC项目负责人和IRB的批准。 预计该方案在任何一年内仅适用于少数患者或家庭。

The aim of this protocol is to provide the mechanism on the UCRC to assess in more detail the characteristics of patients who appear to have unique disease precesses, unique subsets of an already identified disease, unique responses to drug therapy, etc. Occasionally, the UCRC is called by a faculty member concerning a patient or family who appears to be unique. As a first step, it would be desirable to study such patients in a controlled environment such as that offered by the UCRC with a rigidly controlled diet, quantitative collection of urine and feces, and serial sampling of blood for a variety of determinations in either routine or special laboratories. Occasionally such patients can be ""fit"" into already approved protocols, but if they cannot, they can be entered into this special case study protocol. Through this protocol, preliminary information can be gained, and if it does indeed appear that the patient has unique characteristics and warrants further studies, the data generated can be used to develop subsequent protocols. An investigator wishing to utilize this protocol must submit to the UCRC and to the IRB a brief written description of the patient's unique characteristics, with a justification of the proposed use of the UCRC and procedures to be performed. This must be accompanied by a consent form. Approval from both the UCRC Program Director and the IRB must be obtained before the study can be conducted. It is anticipated that this protocol will be applicable to only a few patients or families within any given year.