SOLICITATION NOTICE
Q -- Treatment-Related Second Cancers after Breast Cancer
- Notice Date
- 4/23/2018
- Notice Type
- Presolicitation
- NAICS
- 541380
— Testing Laboratories
- 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
- N02CP82559-24
- Archive Date
- 5/22/2018
- Point of Contact
- Kimesha Leake, Phone: 2402765669, Reyes Rodriguez, Phone: 240-276-5442
- E-Mail Address
-
kimesha.leake@nih.gov, reyes.rodriguez@nih.gov
(kimesha.leake@nih.gov, reyes.rodriguez@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Contracting Office Address Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E134, Bethesda, MD 20892, UNITED STATES Description The National Cancer Institute (NCI), Center for Cancer Research (CCR), Division of Cancer Epidemiology and Genetics (DCEG) plans to procure radiation summaries, information on cohorts, and tissue blocks on a sole source basis from Kaiser Foundation Research Institute (Colorado Region), Kaiser Foundation Hospitals, 1800 Harrison St., 16th floor, Oakland, CA 94612-3416. This acquisition will be processed in accordance with the simplified acquisition procedures as authorized by FAR Part 13.106-1 (b) (1) and is exempt from the requirements of FAR part 6. The North American Industry Classification System Code is 541380 and the business size standard is $15.0 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 shall be for a 12 month base period with one 12 month option period. Base Period: August 1, 2018-July 31, 2019 Option Period: August 1, 2019 -July 31, 2020 It has been determined there are no opportunities to acquire green products or services for this procurement. BACKGROUND Substantial improvements in breast cancer survival, combined with increasing incidence rates have resulted in 3 million breast cancer survivors in the US; 20% of all cancer survivors. The long-term health of these women is a clinical and public health concern, with an estimated 10% developing a second cancer by ten years after diagnosis. About two-thirds receive radiotherapy as part of their initial treatment. Randomized trials established that radiotherapy reduces breast cancer mortality by 3-4% by 15 years, but also increases cardiovascular mortality and second cancer risks. Careful treatment planning can reduce doses to normal tissue, but some dose to the heart, lungs, esophagus and contralateral breast is unavoidable. Newer field configurations and expansion of internal mammary chain irradiation may, however, have started to increase doses again. Whilst ionizing radiation is an established cause of cancer in all the organs likely to receive radiation exposure from breast cancer radiotherapy, there is considerable uncertainty about the magnitude of the risks from fractionated high dose therapy in cancer survivors compared to acute lower-dose exposures. Understanding the risks from high-dose fractionated exposures informs our understanding of radiation carcinogenesis and can also impact clinical practice. To address these issues, the National Cancer Institute (NCI) previously developed a retrospective cohort of 4675 breast cancer survivors (diagnosed 1994-2014, followed-up through 2015) using electronic medical records from Kaiser Colorado (CO) to study the late effects of radiotherapy, chemotherapy and hormonal treatment and to study the risk of contralateral breast cancer (CBC) in relation to radiation organ doses in a nested case-control study. The original electronic treatment records, combined with the detailed radiotherapy records and state-of-the-art dose reconstruction provides a unique cohort in which to evaluate the relationship between more recent radiotherapy practice and late effects such as second cancer risks and cardiovascular disease, accounting for confounding by other treatments and some lifestyle factors such as obesity, hormonal (estrogen) use, and smoking that are available in the medical records. OBJECTIVE The aim of the current procurement is to expand the scope of the breast cancer cohort from Kaiser Permanente Colorado (KP-CO) in a two-year contract to obtain the radiation summaries not previously obtained for patients diagnosed with breast cancer during 2009-2014, obtain full cause of death on the cohort, and prevalence of selected cardiac outcomes, cardiovascular risk factors and co-morbidities indices one year prior to the breast cancer diagnosis. In addition, the procurement will provide for the acquisition tissue blocks for the related study of second contralateral breast cancer (CBC) in this cohort of patients with an initial breast cancer. SCOPE The information obtained under the procurement will be used to evaluate the effects of breast cancer treatments including hormonal therapies, radiotherapy and chemotherapy on outcomes which include contralateral breast cancer (CBC), breast cancer recurrence, other second cancers, cardiovascular disease and death. The current procurement differs from the previous contracts in providing scanned radiation summaries not obtained previously (breast cancer patients diagnosed from 2009-2014), and providing data for the cardiovascular study (full cause of death on the cohort using the National Death Index, incidence of selected cardiac outcomes and cardiovascular risk factors). In addition, the procurement will provide for the acquisition tissue blocks for the related study of second contralateral breast cancer (CBC) in this cohort of patients with an initial breast cancer. The specific aims are: • Radiotherapy study: To retrieve and scan radiotherapy summaries from the medical charts for 1000 breast cancer patients diagnosed during 2009-2014 (KP-CO Expanded cohort). • Mammography study- Archival Tissue Retrieval: For the case- control study of contralateral breast cancer (CBC) occurring in this cohort, to identify tissue blocks from pathological reports and subsequently retrieve archival tissue for approximately 22-29 CBC cases. • Cardiovascular Disease (CVD) study: • To obtain full cause of death from the National Death Index electronic files for all breast cancer patients in the KP-CO cohort diagnosed from 1994 to 2014 and followed through 2015. To obtain cardiovascular incidence events and dates of events for the 1 year prior to the initial breast cancer and during follow-up while enrolled in Kaiser • To obtain specific diseases/conditions related to risk of cardiovascular disease, such as diabetes, hypertension and dyslipidemia, for the 1 year prior to the breast cancer diagnosis and during follow-up while enrolled in Kaiser. CONTRACT REQUIREMENTS/ AND PERSONNEL QUALIFICATIONS For the base period, the Contractor shall perform the following tasks: • Radiotherapy summaries for cohort Time Frame: 8/1/2018-7/31/2019: • The Contractor shall retrieve radiotherapy summaries for women treated with radiotherapy, n=1000, among the existing cohort of breast cancer patients diagnosed 2009-2014 and followed through 2015. The summaries include details of the treatment fields used, the radiation dose/ number of fractions/ machine type for each field from the medical charts. The Contractor shall send scanned copies of the reports to NCI. A radiotherapy summary tracking log (i.e. an Excel spreadsheet including IDs, batch number, breast cancer diagnosis date) shall be prepared by the contractor to be included with each deliverable of scanned radiotherapy summary reports. Log excel files of patients for whom summaries were not available shall be included with IDs, breast cancer diagnosis date and reason for unavailable radiotherapy report. • The Contractor shall respond to data queries from NCI regarding conflicting, inconsistent, or missing information on the radiation summaries obtained from the phase one cohort (breast cancer diagnoses 1994-2008) and any new data queries that may arise on the 1000 radiation summaries cited above for the phase 2 cohort (breast cancer diagnoses 2009-2014). The estimated number of data queries is approximately 300-400. Some data queries may require medical record review to respond to NCI questions. The Contractor shall obtain additional information, when available, to supplement the radiation summaries on the most common treatment fields and prescriptions that are typical for early versus advanced stage breast cancer, use of different wedge angles, physical wedges or dynamic wedges, use of IMRT or partial breast irradiation, and type of linear accelerator (i.e., Varian 600, Varian 2100, Elekta, Varian 21EX), including years of use. • Archival tissue retrieval Time Frame: 8/1/2018-7/31/2019. • The Contractor shall identify tissue blocks from pathological reports and subsequently retrieve archival tissue for CBC cases. The Government estimate that there are approximately 22-27 CBC cases with available paired primary and CBC tissues if blocks, depending on the availability of blocks from 2006+ or 2007+. • The Contractor shall review pathology records for all CBC cases diagnosed within the existing breast cancer cohort (diagnosed in 2006+ or 2007+, depending on availability). This will allow tissue blocks of interest to be identified. Once blocks have been identified, the Contractor shall transfer tissue blocks for processing to NCI [or alternative lab identified by NCI]. The tissue blocks to be identified and retrieved include, paired tumor tissue from the primary and CBC surgery, normal tissue and lymph node tissue blocks obtained from the primary surgery. • Using the surgical pathology reports, the Contractors investigators shall select suitable blocks for pathology studies. Rules for selection of blocks shall be provided by the NCI. Four blocks shall be selected for each woman where possible: • Primary breast cancer tumor block - obtained from surgery of the primary breast cancer • Benign adjacent normal tissue block - obtained from surgery of the primary breast cancer • Lymph node tissue block - obtained from surgery of the primary breast cancer - only selected when the woman is negative for lymph node metastatic disease • Contralateral breast cancer tumor block - obtained from surgery of the second primary breast cancer • Contralateral breast cancer adjacent normal block - obtained from surgery of the second primary breast cancer • Ascertainment of Cause of Death for the Breast Cancer Cohort Time Frame: 8/1/2018-7/31/2019 • The Contractor shall obtain cause of death from the National Death Index for all patients in the KP-CO cohort with breast cancer patients diagnosed from 1994 to 2014 and followed through 2015, who are known to have died but who do not have a valid cause of death on the current cohort file (N=100-200, invalid defined as cause of death =0, 777, 999, and missing). • For those patients who were known to be alive at the end of the Breast Cancer study (12/31/2015) or end of Kaiser enrollment as recorded on most recent cohort file, whichever comes first, the Contractor shall link with NDI to identify vital status (alive or dead) only for those calendar years after the last known alive date up through 2015. (i.e. customized searches). For those who have died, the Contractor shall obtain the cause of death. The estimated number of linkages are about 1,000 (including multiple linkages for individual patients). • The Contractor shall prepare a summary tracking log (i.e. an Excel spreadsheet including IDs submitted to NDI, NDI match (y/n), NDI ICD codes for the underlying cause of death, NDI type of cause of death (Immediate/primary, contributory, underlying and others), NDI coding (ICD-9 or ICD-10), KP Confidence in accuracy of death, and source of the cause of death record). Patients for whom cause of death information were not available shall be also included in the tracking log file. For the option period one, if exercised by the Government, the Contractor shall perform the following tasks: • Ascertainment of cardiovascular disease events and clinical cardiovascular risk factors. Period of Performance: 8/1/2019-7/31/2020 • Prevalence and incidence of cardiovascular disease (CVD) and other cardiac outcomes: • For the entire cohort of women with breast cancer who were diagnosed 1994-2014 with follow-up through 2015, the Contractor shall identify from their electronic files, using inpatient and outpatient procedure and diagnosis codes, occurrences of selected cardiac outcomes (NCI to provide list of cardiac outcomes of interest), from one year prior to the initial first primary invasive breast cancer to the end of follow-up. A summary tracking log (i.e. an Excel spreadsheet including IDs, cardiac outcome (s), diagnosis codes, date(s) of event, shall be prepared by the Contractor. • Clinical cardiovascular risk factors: For the entire cohort of women with breast cancer who were diagnosed 1994-2014 with follow-up through 2015, the Contractor shall capture data on clinical cardiovascular risk factors (including diabetes, hypertension and dyslipidemia) from electronic files, from one year prior to the breast cancer diagnosis to the end of follow-up. A summary tracking log (i.e. an Excel spreadsheet including IDs, disease outcome(s), diagnosis code(s), date(s) of event, shall be prepared by the Contractor. PLACE OF PERFORMANCE At the Contractor's facility. REPORT(S)/DELIVERABLES AND DELIVERY SCHEDULE Technical Progress Reports: The Contractor shall submit Quarterly Progress Reports describing the general progress of the work, as well as any problems encountered. The first quarterly report shall cover the first full three months of the contract, in addition to any fractional part of the initial month. Thereafter, reports shall be submitted on a quarterly basis. Reports shall be due thirty (30) calendar days after the end of the reporting period. A fourth quarterly report will not be required for the period when an annual report or final report is due. The Contractor shall provide study datasets that include data listed above, with data identified only by unique study identification number (ID). All data shall be delivered to Information Management Services, NCI's programming support group, via the Breast Cancer Survivors secure web site - https://portals.dceg.cancer.gov/kaiserbcsc/ and to NCI using the study secure, password-protected file transfer service listed above. All resultant reports will be based on aggregate data that contain no personal identifiers. The Contractor shall provide specific analytic coding schema, programs and supporting information, to accompany the data files. The Contractor shall be required to review progress/performance on the contract with regularly scheduled conference calls, and by providing quarterly progress (as described above) and quarterly financial reports (invoices described below), including costs incurred in the quarter. Radiation Epidemiology Branch previously contracted with Kaiser Permanente Colorado (KP-CO) to develop a retrospective cohort of breast cancer survivors (diagnosed 1994-2014, followed through 2015), using electronic medical records to study the late effects of radiation, hormonal and chemotherapy, particularly the risk of second cancers. The previous KP-CO contract collected data on diagnosis details, tumor characteristics, treatment, and other covariate information from electronic sources and collected details on radiotherapy treatment from the KP-CO hard copy treatment summary reports that are not available in the electronic records. Thus, the KP-CO group is the only known group that can fulfill the current requirement. It was determined that this data source, with the existing breast cancer cohorts utilized in the previous Kaiser CO study, uniquely provide the data, along with level of expertise and familiarity that are not available elsewhere, thus it was determined that no other service provider is able to meet NCI needs. 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 5:00 PM EST, on May 7, 2018. All responses and questions can be emailed to Kimesha Leake, Contracting Officer via electronic mail at kimesha.leake@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. 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: N02CP82559-24 on all correspondence
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