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Renal Cell Carcinoma Genome-wide Association Study: Extraction of Germline DNA Samples from Mayo Clinic Biobank.


Maryland, United States
Government : Federal
RFP
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Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E132, Bethesda, MD 20852, UNITED STATES.

Description
The National Cancer Institute (NCI), Division of Cancer Epidemiology and Genetics (DCEG), Occupational and Environmental Epidemiology Branch (OEEB) plans to procure on a sole source basis services to obtain DNA samples and patient data for renal cell carcinoma cases (RCC) for inclusion in a genome-wide association study (GWAS) from Mayo Clinic Jacksonville; 4500 San Pablo Rd, Jacksonville, FL 32224.

This acquisition will be processed in accordance with simplified acquisition procedures as stated in FAR Part 13.106-1(b)(1).

Only one award will be made as a result of this solicitation. This will be awarded as a firm fixed price type contract.


The North American Industry Classification System code is 541380 and the business size standard is $15 Million.


Period of performance shall be 12 months from date of award.


It has been determined that there is no opportunity to acquire green products or services under this contract.


There is clear evidence that genetic factors influence susceptibility to renal cell carcinoma (RCC), with very high rates of RCC observed among patients with von Hippel-Lindau (VHL) syndrome and other genetic disorders, including hereditary papillary renal cell carcinoma and Birt Hogg Dubé syndrome. However, such familial cases represent a miniscule fraction of overall cases. The contributions of common low-penetrance genetic variants to RCC heritability have become increasingly apparent through genome-wide association studies (GWAS), several of which have been conducted by investigators at the National Cancer Institute (NCI).


It is likely that only a small fraction of common genetic loci affecting RCC risk have been identified to date. In a recent NCI-led GWAS analysis, it was estimated that the total number of RCC loci identified to date explain approximately 10% of disease heritability, suggesting that many more risk variants remain to be discovered. To better understand the role of common genetic variation in RCC susceptibility, NCI is genotyping additional RCC cases to expand the size of its GWAS. This expanded GWAS will comprehensively identify common risk variants with moderate effect sizes, identify several new risk markers of lower frequency or small effect size, and provide the best opportunity to date to identify gene variants associated with specific histologic subtypes and patient survival.


As part of this GWAS expansion, NCI will analyze DNA samples stored at the biobank of the Mayo Clinic, a NCI-designated Comprehensive Cancer Center research facility and hospital, from approximately 1,100 RCC patients.


The Contractor shall:
1) Select RCC cases with banked germline DNA or blood samples;
2) Extract DNA for those subjects without previously extracted DNA;
3) Aliquot and ship DNA specimens from Mayo Clinic patients to NCI and;
4) Provide data for the subjects and assist in answering and resolving study-related questions.

The Contractor shall perform the following tasks.
• The Contractor shall select approximately 1,100 RCC cases (ICD-9 / ICDO-1
89.0; ICD-10 / ICDO-2 C64) with banked germline DNA or blood from its biobank.
• The Contractor shall extract DNA from subjects for whom DNA is not already available and quantify by PicoGreen or similar technique.
• The Contractor shall aliquote a total of 2 micrograms of native genomic DNA from approximately 1,100 subjects containing a concentration of 50-80 ng/ul as quantified by PicoGreen or similar technique in a minimum volume of 25 ul.
• The Contractor shall place the specimens in Sarstedt 1.5mL screw top cryovials (PN 72.703.406) or similar tube labeled with printed human-readable ID and, if possible, a corresponding 1D or 2D barcode. The cryovials containing the specimens will be shipped in clearly labeled freezer boxes.
• The Contractor shall ship the specimens on dry ice to the NCI Staging Laboratory. The shipment of specimens shall occur on either a Monday, Tuesday or Wednesday only via same day or overnight delivery. All specimens will be shipped at the same time.
• The Contractor shall provide a specimen manifest for the samples prior to shipment.
• The Contractor shall provide data for the subjects and assist in answering and resolving study-related questions. The data shall include selected demographic characteristics (age at diagnosis, age at specimen collection, sex, race) and any available risk factors (family history of kidney cancer, smoking status, height, weight, history of hypertension) and clinical data (stage, grade, tumor size, bilaterality, histology, date of death, cause of death, date of first recurrence).


The work shall be performed at the Contractor's facility.


The Technical Point of Contact will review the contents and quality of the specimens sent. The Technical Point of Contact will review the specimen manifest and covariate data provided. If no comments or requests for revisions are provided within 30 days, the deliverables shall be considered acceptable.


DELIVERABLE DELIVERABLE DESCRIPTION / FORMAT REQUIREMENTS DUE DATE
#1 The specimens shall be placed in Sarstedt 1.5mL screw top cryovials (PN 72.703.406) or similar tube labeled with printed human-readable ID and, if possible, a corresponding 1D or 2D barcode. Specimens shall be shipped on dry ice to the NCI Staging Laboratory. The shipment of specimens shall occur on either a Monday, Tuesday or Wednesday only via same day or overnight delivery. All specimens shall be shipped at the same time. 12 months after date of award

#2 The Contractor shall deliver a summary report of the samples aliquoted and shipped at the time of shipment. 12 months after date of award

#3 The Contractor shall provide data for the subjects and assist in answering and resolving study-related questions. The data shall include selected demographic characteristics (age at diagnosis, age at specimen collection, sex, race) and any available risk factors (family history of kidney cancer, smoking status, height, weight, history of hypertension) and clinical data (stage, grade, tumor size, bilaterality, histology, date of death, cause of death, date of first recurrence). 12 months after date of award


Mayo Clinic manages and stores the samples collected from its patients. No other known institution manages specimens from Mayo Clinic biobank. Given the large number of RCC samples available from Mayo Clinic and the detailed clinical information available from these patients, obtaining these samples from this institution is critical to the success of the GWAS by ensuring reasonable statistical power to identify risk variants that are harder (i.e., weaker effect size, rarer frequency) and enabling analyses of patient survival.


This is not a solicitation for competitive quotations. However, if any interested parties, especially small businesses, believe they can meet the above requirement, they may submit a statement of capabilities. All information furnished must be in writing and must contain sufficient detail to allow the NCI to determine if it can meet the above unique specifications described herein. A copy of the capability statement must be received in the NCI Office of Acquisition on or before 11:00 AM EST on August 3, 2018. All questions must be in writing and can be faxed (240) 276-5401 or emailed to Ronette Collins, Contract Specialist at ronette.collins@nih.gov. A determination by the Government not to compete this proposed contract 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. In order to receive an award, contractors must have valid registration and certification on Sam.gov, www.sam.gov. No collect calls will be accepted. Please reference solicitation number N02CP82599-73 all correspondence.


 


Ronette P. Collins, Contracts Specialist, Phone 2402765745, Email ronette.collins@nih.gov - Kimesha Leake, Contracting Officer, Phone 2402765669, Email kimesha.leake@nih.gov

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