SOLICITATION NOTICE
B -- Pilot study of obesity and related conditions and risk of inflammatory breast cancer in the Cancer Research Network
- Notice Date
- 8/1/2018
- Notice Type
- Presolicitation
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E128, Rockville, Maryland, 20852, United States
- ZIP Code
- 20852
- Solicitation Number
- N02CP82625-36
- Archive Date
- 8/25/2018
- Point of Contact
- David H. Romley, Phone: 2402767822
- E-Mail Address
-
david.romley@nih.gov
(david.romley@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- General Information Short Title: Pilot study of obesity and related conditions and risk of inflammatory breast cancer in the Cancer Research Network Document Type: Presolicitation Notice Solicitation Number: N02CP82625-36 Posted Date: 8/1/2018 Response Date: 8/10/2018 Classification Code: B - Special Studies and Analyses NAICS Code: 541990 - All Other Professional, Scientific and Technical Services Contracting Office Address Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E232 Bethesda, MD 20892, UNITED STATES Description The information obtained under this procurement will be used to assess whether the relationship between BMI/obesity and IBC reported previously is evident in the Kaiser Permanente Northern California (KPNC) population. The information obtained under this procurement will also be used to assess whether the relationships between conditions related to obesity (namely, type 2 diabetes mellitus, pre-diabetes, dyslipidemia) reported previously (except for pre-diabetes) are evident in the KPNC population. This acquisition will be processed under FAR Part 12 - Acquisition for Commercial items and will be made pursuant to the authority in FAR 13.106-1(b)(1) using simplified acquisition procedures for commercial items. The North American Industry Classification System code is 541990 and the business size standard is $15,000,000. Only one award will be made as a result of this solicitation. This will be awarded as a firm fixed price type contract. It has been determined there are no opportunities to acquire green products or services for this procurement. Background Inflammatory breast cancer (IBC) is a rare, poorly understood and particularly aggressive form of locally advanced breast cancer. It is characterized by diffuse erythema, edema and peau d'orange of the breast, often with no underlying tumor mass. Thus, it is considered primarily a clinical diagnosis, with pathological confirmation of breast cancer also required. IBC constitutes approximately 2% of breast cancer cases in the United States, but accounts for 7% of breast cancer deaths. A healthcare plan such as Kaiser Permanente Northern California (KPNC) is an excellent platform to elucidate relationships between obesity and IBC, as KPNC possesses high quality electronic medical records for large numbers of women diagnosed with breast cancer as well as maintaining information for all women included in its health care plan. KPNC also provides a suitable platform to overcome difficulties in conducting IBC research as stage, morphology, and extent of diseases codes necessary for the diagnosis of IBC are available. Moreover, KPNC has the necessary research infrastructure as part of the National Cancer Institute-funded Cancer Research Network. Finally, KPNC is large enough to provide an adequate number of IBC cases. Scope The Contractor shall query the KPNC database to: 1) select 402 female IBC cases and 4020 female controls and gather the data listed as detailed per section 4.0 below; 2) prepare a SAS dataset containing these data; 3) deliver the SAS dataset by secure e-mail link to the National Cancer Institute COR. Contract Requirements The Contractor's specific tasks shall include: a) Identify IBC cases and matched controls according to the following case-control design: -All IBC cases at KPNC with at least 13 months enrollment prior to the date of diagnosis or index date shall be selected during years for which at least some required variables are available; -Cases diagnosed at only autopsy or death will be excluded; -Female controls with at least 13 months minimum enrollment (10 times the total number of cases) shall be selected from KPNC enrollees who were alive and breast cancer free as of July 1 (or as of the date of diagnosis of the index case) in the calendar year of selection; -Controls shall be frequency-matched to the distribution among IBC cases on key factors that may include 5-year age category and area of residence. b) Provide case-related variables: IBC cases: Site and Morphology Histologic Type ICD-0-3 = 8530 or Extent of Disease - Historic EOD 10 - extent (1998-2003) = 70 or Extent of Disease - CS.CS extension (2004+) = 71,73, 600, 710, 715, 720, 725, 730, 750, 780 or AJCC TNM = T4d. c) Provide exposure variables within the time period up until 12-months prior to IBC diagnosis: Electronic laboratory data, pharmacy data, and diagnosis data shall be used to obtain the assorted measures, based on algorithms previously developed at KPNC, when available. - BMI: A height of less than 4 feet or 7 feet, 2 inches or greater will be considered implausible and excluded from the analysis. Weight data will be excluded if weight is below 30 or 1000 or more pounds. Because implausible combinations of weight and height may be missed by the procedures described, we additionally will exclude BMI values below 5 or 100 or greater kg/m2 as implausible. BMI will be calculated using the first plausible height and weight measurements in the electronic health record system, as weight (kg) divided by the square of height (m2). - Type 2 diabetes mellitus: (1) elevated glucose levels (fasting glucose >126 mg/dL or random glucose ≥200 mg/dL) measured on two separate occasions; (2) elevated hemoglobin A1C (>7.0%); (3) two or more outpatient visits with International Classification of Disease, 9th modification (ICD) codes (250.XX) for diabetes mellitus; (4) one or more diabetes-related hospital discharge codes; or (5) one or more fills for oral or injected diabetes-specific medications, excluding metformin or any thiazolidinedione if no other criterion was met. Patients who are pregnant during the enrollment period will only be considered diabetic if they meet the criterion outside of the pregnancy time period (16). - Pre-diabetes: fasting plasma glucose (FPG) level of 100 to 125 mg/dL (impaired fasting glucose [IFG]), a 2-h plasma glucose level after a 75-g oral glucose tolerance test of 140 to 199 mg/dL (impaired glucose tolerance [IGT]), or hemoglobin A1c(A1C) 5.7 to <6.5% (39 to < 48 mmol/mol). - Dyslipidemia: (1) at least one prescription for lipid-lowering medication plus an outpatient diagnosis of dyslipidemia (ICD-9 272.0-272.4); (2) at least two outpatient diagnoses of dyslipidemia; (3) at least one prescription for lipid-lowering medication plus at least one elevated low-density lipoprotein cholesterol (≥160 mg/dL); or (4) at least one outpatient diagnosis of dyslipidemia plus at least one elevated low-density lipoprotein cholesterol. Other variables - Date/age at entry into KPNC - Race/ethnicity - Neighborhood education and household income through linkage of a member's address with U.S. census tract information via geocoding. - Mammographic screening between 1 and 4 years prior to diagnosis/selection date - Date of birth - Date/age of diagnosis (for cases) - Date/age of selection for controls - Duration of coverage (months) - accounting for any time gaps in coverage - Most recent height - Date/age height determined - Date/age BMI determined - Date/age diabetes determined - Date/age dyslipidemia determined - Date/age pre-diabetes determined - Estrogen and progesterone receptor status of the IBC cases This solicitation will be sole-sourced to Kaiser FDN Research Institute because this project requires access to electronic health records, availability of variables to identify IBC cases (stage, extent of disease codes, and morphology), a sufficient number of inflammatory breast cancer cases and a research infrastructure that allows access to the data. The Cancer Research Network, of which Kaiser Permanente Northern California is a member, was designed to carry out such projects. Kaiser Permanente Northern California was the only member of the Cancer Research Network that was willing to participate and had a sufficient number of inflammatory breast cancer cases for this analysis. Thus, KPNC is the only known source that can meet the NCI's needs at this time. This notice is not a request for competitive quotation. However, if any interested party, especially small businesses, believes it can meet the above requirement, it may submit a capability statement, proposal, or quotation, which shall be considered by the agency. 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 the requirement. Responses must be received in the contracting office by 12:00 PM EST, on August 10, 2018. All responses and questions must be in writing and faxed 240-276-5401 or emailed to David Romley, Contract Specialist OR via electronic mail at david.romley@nih.gov. 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. No collect calls will be accepted. In order to receive an award, contractors must be registered and have valid certification in the System for Award Management (SAM) through sam.gov. Reference: N02CP82625-36 on all correspondence.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/RCB/N02CP82625-36/listing.html)
- Record
- SN05015308-W 20180803/180801230847-cc8a521a853988dd59a1021ecbccfd7e (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |