A Pilot Study of Colorectal Cancer in Galicia, Spain

描述（由申请人提供）： 我们的总体长期目标是在西班牙加利西亚地区进行一项大规模的、以家庭为基础的结直肠癌遗传流行病学研究。在背景部分，我们描述了为什么我们提出了一个家庭为基础的设计，为什么我们认为加利西亚是一个很好的地区，在其中进行一个家庭为基础的研究结直肠癌。我们在这里提出了一个为期两年的试点研究，以帮助我们规划我们设想的大型研究。这项试点研究的具体目标如下。 1.与治疗加利西亚50%癌症患者的四家医院合作，从每家医院前瞻性地确定和招募10例病例。从每个病例中，我们将获得以下项目：结直肠癌的新鲜冷冻组织和周围组织，石蜡包埋的肿瘤块，血液样本，完成的危险因素问卷，完成的食物频率问卷，以及扩展到二级亲属和堂兄弟的谱系。 2.从这些家庭中招募选定的亲属，并获得以下内容：血液样本，完成的危险因素问卷，完成的食物频率问卷，以及结直肠癌病例，肿瘤块和其癌症的病理报告。 3.在四家医院服务的地区，尝试从每个地区招募两个没有结直肠癌病史的家庭，看看我们对对照家庭的应答率是否与通过结直肠癌病例确定的家庭一样高。 4.根据本试点研究估计以下参数，这些参数将有助于我们规划更大规模的研究：a）先证者对每个数据项的应答率，B）家庭成员对每个数据项的应答率，c）结肠直肠癌和其他癌症的家族史，d）先证者的一级和二级亲属以及堂兄弟姐妹的数量，e）生活在同一家庭和同一村庄的这些亲属的数量，和f）从风险因素问卷和食物频率问卷中选择的风险因素的流行率/分布。此外，完成这项试验研究后，我们会证明进行更大规模的全面研究的可行性。

DESCRIPTION (provided by applicant): Our overall long-term objective is to conduct a large, family-based, genetic-epidemiologic study of colorectal cancer in the region of Galicia, Spain. In the Background section, we describe why we propose a family-based design and why we believe Galicia is an excellent area in which to conduct a family-based study of colorectal cancer. We propose here a two-year pilot study to help us plan the large study that we envision. The specific aims of this pilot study are the following. 1. Collaborate with four hospitals that treat 50 percent of cancer patients in Galicia, to prospectively identify and recruit 10 cases from each hospital. From each case, we will obtain the following items: fresh frozen tissue of the colorectal cancer and surrounding tissue, paraffin-embedded tumor blocks, blood sample, completed risk factor questionnaire, completed food frequency questionnaire, and a pedigree extended to second-degree relatives and cousins. 2. Recruit selected relatives from these families and obtain the following: blood sample, completed risk factor questionnaire, completed food frequency questionnaire, and for cases of colorectal cancer, tumor blocks and pathology reports of their cancer. 3. In the areas served by the four hospitals, attempt to recruit two families from each area with no history of colorectal cancer, to see if our response rates for control families are as high as those for families ascertained through a colorectal cancer case. 4. Estimate from this pilot study the following parameters that will help us plan the larger study: a) response rate of probands for each data item, b) response rate of family members for each data item, c) family history of colorectal and other cancers, d) number of living first- and second-degree relatives and cousins of probands, e) number of these relatives who live in the same household and in the same village, and f) prevalence/distribution of selected risk factors from the risk factor questionnaire and food frequency questionnaire. In addition, by completing this pilot study, we will demonstrate the feasibility of conducting the larger full-scale study.