SOURCES SOUGHT
A -- Determination of Genetic Susceptibility to Lung Cancer in Families from Southern Louisiana
- Notice Date
- 9/13/2010
- Notice Type
- Sources Sought
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Heart, Lung and Blood Institute, Rockledge Dr. Bethesda, MD, Office of Acquisitions, 6701 Rockledge Dr RKL2/6100 MSC 7902, Bethesda, Maryland, 20892-7902
- ZIP Code
- 20892-7902
- Solicitation Number
- NIH-NHLBI-SBSS-HG-12-04
- Archive Date
- 10/3/2011
- Point of Contact
- Deborah S Spillan, Phone: (301) 435-0344, Lynn M Furtaw, Phone: 301-435-0357
- E-Mail Address
-
spilland@nih.gov, lynn.furtaw@nih.gov
(spilland@nih.gov, lynn.furtaw@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- The National Heart, Lung, and Blood Institute (NHLBI), on behalf of the National Human Genome Research Institute (NHGRI), National Institutes of Health (NIH) is conducting a market survey to assess the availability and technical capability of small business firms to collect clinical, environmental and phenotypic data and biological specimens in Louisiana from lung cancer patients, their families and frequency matched normal control individuals for use in studies of the genetic epidemiology of lung cancer. The applicable NAICS Code is 541712 and the size standard is 500 employees. It is anticipated that one award will be made by October 2011 for a period of five years. Lung cancer (LC) is one of the most common cancers in the United States and, despite advances in therapy, one of the most rapidly fatal. There is little doubt that the majority of lung cancer cases are attributable to (i.e. would not occur in the absence of) cigarette smoking and other behavioral and environmental risk factors. However, strong evidence suggests that genes are also involved in LC causation. Investigators at NHGRI and their collaborators have studied the genetic susceptibility to lung cancer for over 25 years, collecting medical information, smoking exposure history and biological samples on families with many affected individuals, as well as lung cancer patients with a family history and unaffected individuals who are matched to the lung cancer patients on age, gender and smoking history. Lung cancer is rapidly fatal. Therefore, many newly diagnosed patients are very ill. In order to enroll patients and their families into this study, newly diagnosed patients must be offered enrollment into the study very shortly after diagnosis. This requires a rapid ascertainment network - the contractor must work closely with all hospitals, oncologists, pathology departments and cancer treatment centers in southern Louisiana in order to attempt to enroll patients shortly after diagnosis (preferably no longer than 3 months after diagnosis). NHGRI's data collection site is in southern Louisiana. NHGRI intends to continue data collection in this area to facilitate ongoing research into genetic susceptibility and gene-smoking interactions that may increase risk of this disease. The contractor will perform the following program requirements: 1) rapidly identify and contact all lung cancer patients newly diagnosed between October 1, 2011 and September 30, 2016 (hereafter called probands) within 27 parishes in southern Louisiana using a rapid ascertainment network and attempt to enroll them into the phase 1 interview portion of the study; 2) perform a brief phase 1 family history interview with these probands to determine how many of their relatives have ever had lung cancer; 3) collect phenotypic and detailed smoking and other environmental exposure data and biologic specimens from selected lung cancer patients (selected because they have a family history of lung cancer that was discovered during the phase 1 interview) and their families to be delivered to the Government so that the following analyses can be performed: genotyping, genetic linkage analyses, familial-case-control genome-wide and targeted association analyses, genome sequencing analyses, and genotype-phenotype correlation analyses. The contractor will complete enrollment of 10-15 new families with adequate data for use in the linkage study and 320-400 probands with a family history for the association study from among the families ascertained during this contract period; 4) collect phenotypic and environmental exposure data and biologic specimens on approximately 320-400 matched control (unaffected) individuals (frequency matched to the probands on age, smoking exposure levels, area of residence, race/ethnicity) who are biologically unrelated to the lung cancer patients for use in the analyses described above; 5) continue follow-up of previously enrolled lung cancer patients and their families to allow updating of new cancer diagnoses within the families; 6) Provide a Statistical Geneticist to assist NHGRI staff with these types of methodological research, as well as to advise the data collection staff about prioritization of their data collection efforts (to ensure collection of the most powerful families), assist NHGRI staff with analyses of the data as needed, and perform evaluations of various statistical genetic methods needed to analyze this extremely complex trait; 7) verify all reported cases of cancer at any site in original patients and in affected relatives by review of hospital charts, pathologist or physician medical records, or death certificates (if appropriate) and information on histologic type whenever available; 8) maintain a database that contains all of the data generated from the study; and 9) provide biologic specimens including whole blood appropriate for DNA extraction, tumor samples and saliva samples to a central repository specified by NHGRI. To accomplish this work, Institutional Review Board (IRB) approval for the protection of human subjects is required from the contractor's organization and the study will also have to be approved by the IRB's of hospitals and universities that participate in the rapid ascertainment network. Small business firms having demonstrated experience in performing the above requirements are invited to submit capability statements. Capability statements must document the following: 1) evidence of the firm's status as a small business under NAICS code 541712 with a size standard of 500 employees; 2) ability to perform and experience in performing the requirements described above; 3) ability to coordinate and manage a contract of this type and experience in performing contracts of a similar nature; 4) demonstration of past success in recruiting patients from an existing cohort for participation in follow-up visits; 5) experience in the collection of data and biospecimens from individuals including in-home visits; 6) qualifications of personnel with training and experience in human genetics and/or genetic epidemiology/statistical genetics, and experience in the study of lung cancer, interview techniques, data collection, data management, computer simulation programs such as SIMLINK and G.A.S.P., and statistical genetics analysis programs such as GENEHUNTER, S.A.G.E., and PLINK; 7) experience obtaining IRB approval for the ethical conduct of human research; and 8) availability of facilities, equipment, and resources necessary for the performance of the requirements identified above. Capability statements submitted in response to this notice that do not provide sufficient information for review will not be considered. Standard company brochures will not be considered a sufficient response to this sources sought synopsis. This is NOT a Request for Proposals (RFP), and responses should NOT include budgetary information. Firms responding to this notice shall provide capability statements (original and three copies) no later than 3:30pm EST on the fifteenth (15th) calendar day from the date of this announcement to the following address: National Institutes of Health, National Heart, Lung, and Blood Institute, Office of Acquisitions, Rockledge II - Room 6138, 6701 Rockledge Drive - MSC 7902, Bethesda, MD 20892-7902 (use 20817 for express mail), Attention: Deborah Spillan, Contract Specialist. Capability statements may also be emailed (as a Word document or PDF) to Deborah Spillan at: spilland@nih.gov. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted.
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