National Cancer Institute, Research Contracts Branch, PSAS, 6120 Executive Blvd, EPS/Room 638, Bethesda, MD 20892-7227

A -- LINKED -- REGISTRY STUDY OF CANCER RISK IN OFFSPRING OF WOMEN EVALUATED FOR INFERTILITY SOL RFQ-NCI-80238-NV DUE 092298 POC Debbie Moore, Purchasing Agent, 301-402-4509, Todd Cole Contracting Officer, 301-402-4509 The Environmental Epidemiology Branch (EEB), Division of Cancer Epidemiology and Genetics (DCEG), National Cancer Institute(NCI) plans to procure the services of the Danish Cancer Society, Danish Cancer Registry, Strandboulevarden 49, Box 839, DK 2100 Copenhagen, Denmark. The purpose of this requirement is to obtain population-based data on cancer risk in offspring of women who took fertility drugs. Use of fertility drugs has increased markedly over the past two decades. Concern over the carcinogenic potential of these drugs was raised by case reports of ovarian tumors in women who had taken them. Studies have not disproved an association, and investigation of this issue is ongoing. Of concern also are effects on the offspring of pregnancies resulting from fertility drug use. The concerns arise from case reports of ovarian dysplasia and hepatoblastoma in infants born to mothers who had used hormones for fertility. Because of the widespread use of these drugs, the question of whether cancer risk in offspring is elevated is of great importance, and it is necessary to immediately study this concern. To investigate the association of ovulation induction drug exposure to the conceptus and childhood cancer, it is necessary to have a linked registry data of a significant cohort and have the ability to identify the offspring. Denmark retains several registries of population data. In fact, the Danish National Hospital Discharge Register, a database containing date of admission and numerical codes for diagnoses and procedures on all patients admitted to hospitals in Denmark since 1976 was used to identify women with infertility. The aforementioned study will also include women seen at private clinics in order to obtain data from people who do not use the national health care insurance. The final cohort, which is readily and efficiently obtainable, will include 45,000 women. This final cohort of women evaluated for infertility will be computer linked to the Central Population Register by use of identifying numbers unique to Danish inhabitants. This linkage will establish vital status (dates of death or emigration, etc.) for the cohort. At this point, the cohort can be readily linked to the National Birth Register to link mothers with offspring and to obtain information about pregnancy and births. The ability to link mother with their biological children for such a large cohort is a significant advantage of using the Danish registries, as opposed to other registries. Finally, this cohort of offspring can be linked to the Danish Cancer Registry to identify cancer in the offspring. The Danish Cancer Registry was established in 1943, and it is based on reports of cancer cases directly from hospital departments, pathologists, general practitioners, and supplemental information from death certificates. In effect, unlike most registries, the above structure is virtually complete and comprehensive from birth through death. In addition to the above advantages, Dr. Kjaer from the Danish Cancer Registry will oversee all necessary linkages. Since Dr. Kjaer is an internationally known expert on the relationship of infertility and cancer who is intimately familiar with such a comprehensive cohort and linkage structure, her expertise for creating the required linked data set is valuable. Since the Danish Cancer Society, Danish Cancer Registry has an accessible cohort of infertile women, and an effective means to link mothers with their biological offspring, this study can be readily facilitated. Further, because of the size of the anticipated cohort of infertile women, there will be sufficient statistical power for examining effects of exposure to fertility medications among offspring. Therefore, the Danish Cancer Society is the only source known to NCI that can meet all of the above requirements. If any interested party believes it can perform the above requirement with a comparable size cohort with at least as reliable linkages, it may submit a statement of capabilities. The statement of capabilities and any other information furnished must be in writing and must contain material in sufficient detail to allow NCI to determine if the party can perform this requirement. Capability statements must be received in the contracting office by 3:00 p.m. EST, on September 22, 1998. If you have any questions, please contact Debbie Moore, Purchasing Agent on (301) 402-4509. A determination by the Government not to compete this proposed requirement based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. Posted 09/04/98 (W-SN246490). (0247)

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