SOLICITATION NOTICE
B -- Evaluation of molecular markers and risk models in women at increased risk of endometrial cancer.
- Notice Date
- 8/2/2014
- 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
- N02CP42603-83
- Archive Date
- 9/2/2014
- Point of Contact
- Gwennifer K. Epps, Phone: 240-276-5445, Terry Galloway, Phone: 240-276-5384
- E-Mail Address
-
eppsg@mail.nih.gov, gallowaytl@mail.nih.gov
(eppsg@mail.nih.gov, gallowaytl@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- The National Cancer Institute (NCI), Division of Cancer Epidemiology and Genetics (DCEG), Hormonal and Reproductive Epidemiology Branch (HREB), plans to enroll 300 women at increased risk of endometrial cancer on a sole source basis with Mayo Clinic, 200 First St SW, Associated Bank Building, Rochester, MN 55905, USA. This process will be processed in accordance with simplified acquisitions procedures as stated in FAR Part 13 13.106-1(b)(1) and is exempt for the requirements of FAR Part 6. The North American Industry Classification System code is 541990 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. It has been determined there are no opportunities to acquire green products or services for this procurement. Period of performance will be from September 2014, until September 2015. The Hormonal and Reproductive Epidemiology Branch (HREB) conducts research to identify groups at high risk of cancer, clarify the natural history of various cancers, understand the interactive effects of genetic and environmental factors on cancer risk, and elucidate biologic mechanisms of carcinogenesis. HREB's research mission is to focus on hormonal and reproductive cancers, and other malignancies with possible hormonal etiologies (e.g., liver, esophageal). Endometrial cancer is the most common gynecological cancer in the U.S., with an estimated 43,500 incident cases and 8,000 related deaths in 2010. Obesity is a strong risk factor for endometrial cancer, and data in some populations suggest that rates of endometrial cancer and its precursors are rising, mirroring the growing prevalence of obesity. Most endometrial cancers develop slowly through progression of well characterized precursors, many of which regress with progesterone treatment or are curable with hysterectomy. Thus, early detection of endometrial cancer precursors should enable prevention of many endometrial cancers and reduce mortality. Therefore, researchers at the National Cancer Institute have developed risk prediction models to evaluate endometrial cancer risk based on risk factor data such as BMI and parity. The purpose of this acquisition is to enroll 300 women at increased risk of endometrial cancer. From all women, biological specimens shall be collected with a Tao brush and a tampon. In addition, frozen tissue specimens and blood samples, as well as covariate data for relevant endometrial cancer risk factors shall be collected. CONTRACTOR REQUIREMENTS 1. he contractor shall enroll 300 women attending various clinics in the Departments of Obstetrics and Gynecology and Gynecologic Oncology because of clinical symptoms (abnormal bleeding, discharge, thickening of the endometrial stripe), obesity, Lynch syndrome or tamoxifen use. •22. The contractor shall attempt to collect a blood specimen from all women enrolled in the study. •33. The contractor shall collect tampon samples and Tao brush samples before women undergo endometrial biopsy or hysterectomy. •44. The contractor shall collect part of the endometrial biopsy sample and snap freeze the specimen. •55. The contractor shall collect risk factor information (including BMI, smoking, hormonal and reproductive risk factors, family history, medications, and history of bleeding, discharge) in an Excel sheet •66. The contractor shall extract DNA from the tampon and Tao brush specimens •77. Among women referred for hysterectomy, the contractor shall collect frozen tissue from the hysterectomy specimen. •88. The contractor shall store the DNA specimens at -70C until methylation and mutation measurement. The molecular analyses include measuring a set of candidate markers that will be finalized after enrollment has been completed. •99. NCI and the contractor shall work together on the data analysis and publication of the results. Together with the proposed contractor, HREB has conducted a pilot study of enrolling women with endometrial cancer and normal controls to evaluate the novel sampling approaches that NCI wants to evaluate in this study. HREB now propose to extend the enrollment to additional populations of women at increased risk of endometrial cancer at Mayo Clinic, including women with Lynch Syndrome and tamoxifen users that have not been targeted so far. Based on the experience of the Mayo clinic, NCI feels the contractor is uniquely qualified to carry out the proposed study for several reasons: (1) Mayo Clinic has developed the clinical procedures for this type of research and has successfully enrolled a large number of women into a previous study. Mayo has a large and stable population of women at increased risk of endometrial cancer. (2) Mayo has an established infrastructure for enrolling patients into clinical studies, sampling blood, and sampling tissues, that NCI successfully used for the previous effort. (3) Mayo nurses and clinicians are proficient using the novel sampling approaches that we established in collaboration. No other site has this experience and it would require a considerable effort to establish these procedures at other sites. This is not a solicitation for competitive quotations. However, if any interested party especially small business, believes 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. An original and one copy of the capability statement must be received in the NCI Office of Acquisitions on or before 11:00 AM EST on, August 18, 2014. No electronic capability statements will be accepted (i.e. email or fax); an original and one copy must be sent to the NCI Office of Acquisitions at the address stated above. All questions must be in writing and can be faxed (240) 276-5401 or emailed to Gwennifer Epps, Contracting Officer at eppsg@mail.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 in the Central Contractor Registration (CCR) and the Online Representations and Certifications Applications (ORCA), through sam.gov. No collect calls will be accepted. Please reference solicitation number N02CP42603-83 on all correspondence.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/RCB/N02CP42603-83/listing.html)
- Place of Performance
- Address: National Cancer Institute/NIH, Rockville, Maryland, 20850, United States
- Zip Code: 20850
- Zip Code: 20850
- Record
- SN03447701-W 20140804/140802233020-7550f59f83765dfb5c8858603c8ad97e (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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