The National Cancer Institute (NCI), Center for Cancer Research (CCR), Laboratory of Human Carcinogenesis (LHC), plans to procure on a sole source basis urine and plasma biospecimens and associated data (between 0.5 and 1 mL of urine samples and 100uL of plasma) from American College of Radiology Imagining Network (ACRIN) in partnership with the National Lung Screening Trial (NLST), Biospecimen Repository, 1818 Market Street, Suite 1600, Philadelphia, PA 19103. This acquisition will be processed in accordance with simplified acquisition procedures as stated in FAR Part 13.106-1(b)(1). The North American Industry Classification System code is 541380 and the business size standard is $14.0 Million. Only one award will be made as a result of this solicitation. This will be awarded as a firm fixed price type contract. The period of performance is six (6) months from date of award. It has been determined there are no opportunities to acquire green products or services for this procurement. NCI/CCR/LHC has been approved to investigate whether urinary metabolite and serum cytokine profiles previously shown by The National Cancer Institute (NCI), Laboratory of Human Carcinogenesis (LHC) to have diagnostic/prognostic utility in lung cancer can be used to distinguish benign from malignant lung nodules as detected by LDCT. The samples will be sent to the LHC by the NLST-ACRIN Bio-repository and will be pulled from all three screening time points (T0, T1 and T3). The results of this study may lead to novel clinical molecular biomarkers that can complement LDCT and improve its very high false positive rate of 96.4%. The NLST is a randomized trial of screening with the use of low-dose CT as compared with screening with the use of chest radiography. This trial was a collaborative effort of the Lung Screening Study (LSS), administered by the NCI Division of Cancer Prevention, and the American College of Radiology Imaging Network (ACRIN), sponsored by the NCI Division of Cancer Treatment and Diagnosis, Cancer Imaging Program. From August 2002 through April 2004, 53,454 persons at high risk for lung cancer at 33 U.S. medical centers were enrolled in the trial. Participants were randomly assigned to undergo three annual screenings with either low-dose CT (26,722 participants) or single-view posteroanterior chest radiography (26,732). Data were collected on cases of lung cancer and deaths from lung cancer that occurred through December 31, 2009. The studies that will be carried out by the LHC will be done utilizing 466 lung cancer cases and 932 non-cancer controls, all of whom had a suspicious lung nodule detected by LDCT, but the non-cancer controls were subsequently determined to be cancer free by further diagnostic methods. The controls are matched to cases at a 2:1 ratio using incidence-density sampling (which will match for both time on study and the number of screens), and matched on age at diagnosis ( 5 years), smoking status (current/former), gender (male/female), cigarettes per day ( 1) and duration of smoking ( 3 years).This project is being initiated within the Laboratory of Human Carcinogenesis (LHC). This is a unique research contract and since ACRIN is the only research institution that possess the samples collected from the NLST lung cancer screening trial to date that has shown a reduction in lung cancer mortality, NSLT is the only trial that fits these criteria. Contractor Technical requirements: The contractor shall provide the LHC between 0.5 and 1 mL of urine samples and 100uL of plasma in order for the metabolite (urine) and cytokine (plasma) measurements to be conducted. The requirements for such volumes are in order for 5-10% samples to be duplicated for reproducibility assessments. The contractor shall only provide the samples and the associated data. Measurements of metabolites (urine) and cytokines (plasma) will be conducted by the LHC. Targeted liquid chromatography coupled to tandem mass spectrometry (LC-MS/MS) will be utilized to measure the metabolite levels. Plasma cytokines will be measured using electrochemiluminescence immunoassay (ECLIA) plates based on 2 geometries (Human ProInflammatory 4-plex and CRP single-plex Ultra-Sensitive Kit; Mesoscale Discovery, Gaithersburg, MD). Data elements that will accompany the samples are as follows: Demographic/Health Status Questionnaire, Smoking Status Questionnaire, Diagnostic Evaluation Form, Primary Lung Cancer Diagnosis Form, Pre-Registration Eligibility Form, Registration/Eligibility Form, Specimen Packing Form (Blood/Urine), Biomarker Collection Form, Pulmonary Function Test Form, Treatment Form- Initial, Treatment Form - Subsequent, Cancer Progression Form, Interval Follow-Up Questionnaires and Forms, Follow-up Procedure Form, 1-8 years Follow-up Coversheets, Screening CT Form. Therefore, the samples shall be accompanied by very detailed demographic and clinical characteristics relevant for downstream data analyses. All data analyses will be performed by the LHC. Reporting Schedule: All data analyses will be conducted by the LHC and collaborating biostatisticians. Data will be communicated to the contractor's biostatistics team before any work for publication is submitted. There is no time frame on when the analyses will be completed after the samples and required data elements are obtained by the LHC. Time frame: 8-10 weeks for samples to be received from contractor after contract award.. This notice is not a request for competitive quotation. However, if any interested party, especially small business believes it can meet the above requirement, it may submit a proposal or quote for the Government to consider. The response 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 11 AM EST, on March 7, 2014. All responses and questions must be in writing and faxed to
+1 (555) 000-0000 or emailed to Reyes Rodriguez, Contracting Specialist via electronic mail at
contact@example.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 Central Contractor Registration (CCR) and the Online Representations and Certifications Applications (ORCA) through sam.gov. Reference: N02RC42513-57 on all correspondence.
