Request for Information (RFI): Notice of Request for Information on Cancer and Normal Tissue Acquisition and Processing Variables

Notice Number: NOT-CA-08-002 - (See Notice NOT-CA-08-012 Extending the Receipt date to February 29, 2008)

Key Dates
Release Date: January 16, 2008

Issued by
National Cancer Institute (NCI), (http://www.cancer.gov)

This Request for Information (RFI) is for information and planning purposes only and should not be construed as a solicitation or as an obligation on the part of the Federal Government, the National Institutes of Health (NIH), and the National Cancer Institute (NCI).  The NCI does not intend to award a cooperative agreement, grant, or contract on the basis of responses to this RFI or to otherwise pay for the preparation of any information submitted or for the Government's use of such information.  Based on the response to this RFI, the NCI may issue a Request for Proposals (RFP) at an undetermined time in the future.  

Purpose:

This Notice is a time-sensitive Request for Information (RFI) on the state of the technologies and methodologies for acquiring, handling, processing, annotating, storing, and distributing cancer and normal tissue biospecimens.  Information submitted in response to this RFI will be used confidentially by the Government to assess the feasibility of systematic studies on the impact of pre-analytical variables in human specimens on downstream molecular analyses, and to determine current capabilities for biospecimen collection.

Responses (no longer than 25 pages in MS Word or pdf format) may be submitted via e-mail to Mr. Timothy Crilley, Contracting Officer, NCI, at tcrilley@mail.nih.gov.  All responses must be received by 5:00 PM (Eastern prevailing time) on February 8, 2008.

Background:

Human specimens are essential resources for the development of molecular diagnostic, prognostic, and therapeutic tools for molecular medicine.  High-quality, clinically well-annotated human specimens are needed for:
•       Identification and validation of targets for prevention, detection, diagnosis, prognostication, and treatment of cancer;
•       Elucidation of disease mechanisms;
•       Development of a molecular-based taxonomy of cancer;
•       Development of screening tests for specific cancers based on molecular biomarkers;
•       Identification of molecular biomarkers that predict treatment responsiveness and toxicity; and
•       Development of robust technologies to translate research advances into clinical practice.

Information gathered by the NCI over the past 5 years indicates a significant heterogeneity in the methods used to collect, process, store, and disseminate human specimens. This heterogeneity can result in pre-analytical variation that may impact laboratory and clinical research as well as development and interpretation of diagnostic and predictive biomarker assays.  Such variation can affect many novel technologies for gene and protein expression profiling as well as for routine diagnostic tests (such as HER-2/neu immunohistochemistry in breast cancer).  For example, several recent studies suggest that specific procedural variables (e.g., the length of time between surgical excision and biospecimen freezing, conditions of tissue fixation, procedures for blood collection and separation, and conditions of sample storage) produce variations in gene expression patterns and in detection of protein biomarkers.  However, the precise relationships between biospecimen handling and the quality and reproducibility of data for cancer diagnosis and research remain inadequately defined.

Ongoing NCI-sponsored research initiatives in cancer genomics, epigenomics, proteomics, and nanotechnology depend on the development of new sources of high-quality human specimens and the identification of appropriate human specimens in existing resources.  The NCI Office of Biorepositories and Biospecimen Research (OBBR) was established in 2005 to guide, coordinate, and develop the NCI's human specimen resources and capabilities (http://biospecimens.cancer.gov).  The mission of OBBR is to raise the quality of human specimens for cancer research and emerging personalized medicine through evidence-based approaches.  As part of this mission, it is essential to systematically explore the impact of key biospecimen pre-analytical variables on downstream molecular analyses.

Information Requested:

To allow for a systematic examination of key pre-analytical variables in the area of human specimen collection and utilization, responses are sought from medical institutions and/or their inter-disciplinary teams involved in the collection of surgically resected human specimens that are: 1) properly consented for research use and available for distribution; 2) extensively annotated with regard to acquisition and processing variables, beginning in the operating room and continuing through tissue processing and storage; and 3) accompanied by integrated data records including patient clinical and pathology information.

Information is sought for each of the following main areas that comprise the workflow for generating research biospecimens, and the systems utilized to provide a complete history of the biospecimen:

Further definition for each of these areas is provided below.  Information is sought on the entire workflow for generating research biospecimens as graphically represented at http://biospecimens.cancer.gov/science/lifecycle.  Institutions may wish to form inter-disciplinary teams to develop responses to this RFI, as the biospecimen workflow utilizes expertise from many disciplines (e.g., surgeons, anesthesiologists, nurses, pathologists, pathology assistants, laboratory managers, medical technologists).  Please provide information for these topics, including topics within/not within current and future capabilities.

Responses to this RFI do not need to address all aspects of this RFI.  Responses can address specific sections or a portion of the RFI.

I. General Information

II. Patient Recruitment and Consent

Patient recruitment, consent, and biospecimen data de-identification* practices are key parts of human specimen collection.  If applicable to your institution, please respond in regards to the following:

*For more information on de-identification practices, please refer to http://privacyruleandresearch.nih.gov/pr_08.asp#8a.

III. Medical and Surgical Procedures Leading to Human Tissue Acquisition for Research Specimens

With regard to collection of surgical resection tissues from the operating room (OR), please provide information on facilities, staff, procedures, and intra-operative variables routinely recorded, including but not limited to the following aspects:

IV. Human Research Specimen Processing and Storage

With regards to routine institutional procedures for annotation, processing, and workflow management of newly collected surgical resection tissues, please comment on the following issues:

V. Human Research Specimen Distribution

Please describe capabilities for distribution of biospecimens and related data, including, but not limited to:

Additional comments relevant to this RFI, and addressing issues that are not specifically mentioned above, are also encouraged.

How to Submit a Response:

Please limit your responses to 25 pages or less.  Brevity and structured format (such as bulleted items) are encouraged whenever applicable to aid in processing.  The Government prefers that responses be submitted in MS Word or pdf format via e-mail to:

Mr. Timothy Crilley,
Contracting Officer, NCI
E-mail: tcrilley@mail.nih.gov

If using U.S. Postal Service:
Tim Crilley
Contracting Officer
National Cancer Institute
Office of Acquisitions
244 Miller Drive, P.O. Box B, Room 116A
Fort Detrick
Frederick, MD 21702-1201

If using a hand-delivery or courier service:
Tim Crilley
Contracting Officer
National Cancer Institute
Office of Acquisitions
244 Miller Drive, Room 116A
Fort Detrick
Frederick, MD 21702-1201

NOTE:  Ft. Detrick is a secured military base.  If using a hand-delivery or courier service, please contact Tim Crilley to schedule a time for the delivery of your response.

Responses will be accepted through 5:00 PM (Eastern prevailing time) on February 8, 2008.

All information provided will be processed and analyzed confidentially.  Respondents will not be notified of the results of this RFI.

Inquiries

Inquiries concerning this Notice may be directed to:

Tim Crilley
Contracting Officer
Office of Acquisitions
National Cancer Institute
Telephone: 301-228-4224
E-mail: tcrilley@mail.nih.gov


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