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FBO DAILY ISSUE OF APRIL 30, 2003 FBO #0517
SOLICITATION NOTICE

A -- Pre-testing and piloting of questionnaires and other data collection techniques to the Stavanger Nested Case-Control Study of Pre-clampsia

Notice Date

4/28/2003
 

Notice Type

Solicitation Notice
 

Contracting Office

Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Research Contracts Br., 6120 Executive Blvd. EPS Suite 600, Rockville, MD, 20852
 

ZIP Code

20852
 

Solicitation Number

NCI-30048-NG
 

Archive Date

5/29/2003
 

Point of Contact

Malinda Holdcraft, Purchasing Agent, Phone (301) 402-4509, Fax (301) 402-4513, - Renita Smith, Contract Specialist, Phone 301-496-8612, Fax 301-480-0241,
 

E-Mail Address

holdcram@exchange.nih.gov, rs442i@nih.gov
 

Description

The National Cancer Institute (NCI), Basic Research Laboratory (BRL), Center for Cancer Research (CCR) plans to procure Pretesting and piloting of questionnaires and other data collection techniques to the Stavanger Nested Case-Control Study of Preeclampsia with the Rogaland Central Hospital, PO Box 8100, NO-4068 Stavanger, Norway. The acquisition is being conducted under the simplified acquisition procedures authorized in FAR Part 13. The North American Industry Classification System Code is 541710 and the business size standard is 500 employees. Background: The Basic Research Laboratory, Center for Cancer Research, NCI, requires the pretesting and piloting of questionnaires and other data collection techniques in a high-risk population of mothers and children who participated in a birth study when the mothers suffered from preeclampsia during the index pregnancy in comparison with an age-matched set of normotensive controls (mothers and their offspring). The ultimate purpose of this research project is to explore the biological mechanisms underlying why women who suffered from preeclampsia during pregnancy and their offspring are at significantly reduced risk of breast cancer (in mothers and daughters of that pregnancy) while the male offspring are at the lowest risk of prostate cancer identified in the literature. The information collected during the pretest and pilot shall enable the investigators at NCI in collaboration with the investigator and The Rogaland Hospital, Stavanger, Norway to develop a follow-up of the cohort with the ultimate goal of identifying hormonal and other mechanisms associated with the lowered cancer risk in this population. They have conducted the only population-based study of women diagnosed with preeclampsia in pregnancy and their offspring and a comparable set of normotensive controls. The original birth study identified hormonal differences in the cord blood of the offspring of the preeclamptics versus the normotensive controls. These hormones are associated with reduced risk of breast cancer in animal models and in human epidemiologic research. Nonetheless there are no data collected on a population such as this following birth till the age at diagnosis of adult cancer. It is our intent then to pretest and pilot forms and other tools for use in a follow-up of this population as the offspring enter puberty and adolescence, when hormonal and other growth factors might differ appreciably from children of normotensive pregnancies. This is the only population-based study to date of preeclampsia and these women represent all women, who were diagnosed with pre-eclampsia in the birth years from 1993 through 1995 who resided in Stavanger Province, Norway and who delivered a live birth. The birth study utilized data from the birth registry in Norway and stored cord bloods to demonstrate hormonal and anthropometric differences in the offspring of the preeclamptic and normotensive mothers. The NCI has the opportunity to develop a follow-up of these mothers and children, linking with the original study database. The questionnaire items focus on dietary intake during the index pregnancy and since the birth of the index child, lifestyle and demographic characteristics, family history of cancer, and family history of reproductive disease, including preeclampsia in the mother's and biological father's families. The pretest and pilot of this form in the mothers and the pretest of a brief questionnaire about physical activity in children aged 10 years shall provide valuable feedback to the study team for the conduct of the follow-up. Given the large sample size of 1,000 in the original birth study, there is the opportunity to have the statistical power to compute hormonal and other growth factor differences in the formal follow-up study population. Contractor Requirements: The Contractor shall perform the following tasks: 1) Select a sample for the pilot study from among the original study population; 2) Send invitation letters to the pilot study group, 3) Pretest and pilot all study forms, including: a) The maternal questionnaire, b) The child's physical activity questionnaire, c) Identify the optimal times to travel mothers and children to the hospital for a pilot study, e) Complete a clinical evaluation of the pubertal stage and anthropometric status of the children, f) Identify whether mothers and children are willing to have blood drawn for hormone assays and whether the children are willing to wear pedometers, g) Compare assessments by two different pediatricians of the pubertal staging in a small subsample of children and, h) Identify any problems in forms and other data collection techniques. Rogaland Hospital shall perform the pilot study, develop a qualitative description summarizing any problems in logistics and conduct of the pilot study, and submit the summary to the government. None of this information will include personal identifiers. Period of Performance: June 1, 2003 through September 30, 2003. Rogaland Central Hospital is the only known source that can provide the aforementioned requirements. The Rogaland Hospital has as its director, the original Principal Investigator to the Stavanger Nested Case-Control Study of Preeclampsia, who has had direct contact with all the families involved in the original study, thereby having credibility and links to the study population of interest. The efforts and insights from the original study as well as the leadership position at the hospital provide extraordinary opportunity and support for the conduct of this pretest and pilot. The training in obstetrics and gynecology along with the experience of the Pediatric Department in adolescent medicine has given the team the knowledge and background to conduct the pilot. Therefore the background of the population, nature of its low risk for cancer, as well as the expertise and educational background of the original principal investigator and his team are all reasons for the sole source justification. This notice of intent is not a request for competitive quotation. However, if any interested party believes it can meet the above requirements, it may submit a statement of capabilities. The capability statement and any other furnished information must be in writing and must contain material in sufficient detail to allow NCI to determine if the party can fully meet the requirements herein. Capability statements must be received in the contracting office by 1:00 PM EDT (local Washington DC time) on May 14, 2003. If you have any questions, please submit them in writing via electronic mail to Malinda Holdcraft, Purchasing Agent on holdcram@exchange.nih.gov or by fax 301-402-4513. A determination by the Government not to compete this proposed requirement based on responses to this notice is solely within the discretion of the Government. Information received shall be considered solely for the purpose of determining whether to conduct a competitive procurement. No collect calls will be accepted.
 

Place of Performance

Address: NIH/NCI, 9000 Rockville Pike, Bethesda, MD

Zip Code: 20892

Country: USA
 

Record

SN00313317-W 20030430/030428213316 (fbodaily.com)
 

Source

FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)

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