FERTILITY DRUG USE AND RISK OF OVARIAN CANCER

生育药物的使用和卵巢癌的风险

• 批准号: 2392462
• 负责人: MARY ANNE ROSSING
• 金额: $ 28.61万
• 依托单位: FRED HUTCHINSON CANCER RESEARCH CENTER
• 依托单位国家: 美国
• 财政年份: 1996
• 资助国家: 美国
• 起止时间: 1996-04-01 至 2000-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2392462
• 关键词: blood chemistry; brca gene; cancer risk; case history; clinical research; clomiphene; drug adverse effect; drug related neoplasm /cancer; female; fertility promoting drug; human genetic material tag; human middle age (35-64); human population study; human subject; interview; neoplasm /cancer genetics; ovary neoplasms; reproductive system disorder chemotherapy; women's health; young adult human (21-34)

Currently, more than one million U.S. women each year seek treatment for infertility. This number continues to increase, as more women delay childbirth until later ages, adoption becomes increasingly difficult, and the recognition of new, sophisticated technologies for assisted reproduction becomes more widespread. Recently, there has been increasing concern regarding the potential neoplastic effects of the powerful ovulatory stimulants used in the treatment of infertility. In a recently completed study, we observed a strong increase in risk of ovarian cancer associated with use of clomiphene citrate for greater than one year (adjusted RR=11.1, 95% CI 1.5-82.3). The biological plausibility of an effect of ovulation-inducing agents on risk of ovarian cancer, the increasing prevalence of exposure to these drugs, and the limited data currently available all indicate a strong need for further research. We propose to conduct a population-based case-control study examining risk of ovarian cancer associated with the use of fertility drugs, including ovulation-inducing agents such as clomiphene citrate and exogenous gonadotropins. Cases will be women aged 35-54 diagnosed with ovarian cancer from May 1 1995- April 30, 1998 in 3 study sites. Controls will be similarly aged women selected by random digit dialing in each of the study sites. Details regarding medical evaluation and/or treatment for infertility will be elicited at in-person interview, as will information regarding family cancer history and other known and potential risk factors for ovarian cancer. Information regarding the types, dosage and duration of infertility treatments received will also be abstracted from infertility clinic medical records. Blood samples will be collected at the time of interview and white cells will be stored to enable future genetic testing (e.g., for the presence of the BRCA1 gene) to examine the effect of inherited genetic susceptibility to ovarian cancer on the relationship between fertility drug use (as well as other environmental factors) and risk of this disease. Our proposed study is efficient as it will use as controls, at no cost to this study, approximately 2000 women interviewed as controls for an MCHD- funded multi-center case-control study of breast cancer (the Women's CARE study) which will be conducted concurrently with and in the same geographic areas as this study. Further, the population-based case-control design of our study will enable us to assess whether infertile women without exposure to ovulation-inducing drugs are at an increased risk of ovarian cancer, or, alternatively, whether any increase in risk of ovarian cancer associated with infertility may be due to the use of fertility drugs.

目前，每年有超过一百万美国女性寻求治疗 不孕症。随着越来越多的女性推迟，这个数字还在继续增加 生育到晚年，收养变得越来越困难，并且 对新的、先进的辅助技术的认可 繁殖变得更加普遍。近来，越来越多 对强效药物潜在的肿瘤效应的担忧 用于治疗不孕症的排卵刺激剂。在最近的一次 完成的研究，我们观察到卵巢癌的风险大幅增加 与使用克罗米芬柠檬酸盐超过一年有关 （调整后 RR=11.1，95% CI 1.5-82.3）。生物学合理性 促排卵药物对卵巢癌风险的影响 这些药物的接触率不断增加，且数据有限 目前可用的所有内容都表明强烈需要进一步研究。 我们建议进行一项基于人群的病例对照研究来检查风险 卵巢癌与使用生育药物相关，包括 促排卵剂，例如克罗米芬柠檬酸盐和外源性药物 促性腺激素。病例将是35-54岁被诊断患有卵巢癌的女性 1995年5月1日至1998年4月30日在3个研究中心进行的癌症研究。控制措施将是 在每项研究中通过随机数字拨号选择年龄相仿的女性 网站。有关医疗评估和/或治疗的详细信息 不孕症将在面对面访谈中被引出，信息也将被引出 关于家族癌症史和其他已知和潜在的危险因素 用于卵巢癌。有关类型、剂量和持续时间的信息 接受的不孕不育治疗也将从 不孕不育诊所医疗记录。血液样本将在 采访时间和白细胞将被存储，以便将来进行遗传 测试（例如，BRCA1 基因的存在）以检查效果 遗传易感性与卵巢癌的关系 生育药物的使用（以及其他环境因素）和 这种疾病的风险。 我们提出的研究是有效的，因为它将用作对照，而无需花费任何成本 在这项研究中，大约 2000 名女性接受了采访，作为 MCHD 的对照。 资助的乳腺癌多中心病例对照研究（Women's CARE 研究）将与同一研究同时进行 作为本研究的地理区域。此外，基于人群的病例对照 我们的研究设计将使我们能够评估不孕妇女是否 如果没有接触促排卵药物，则患此病的风险会增加 卵巢癌，或者卵巢癌风险是否增加 与不孕相关的癌症可能是由于使用生育能力 药物。