Pre-solicitation_4232280.doc

General Information

Short Title: Data collection services on treatment-related second cancers after breast cancer.

Document Type:

Presolicitation Notice

Solicitation Number:

N02CO62688-78

Posted Date: 08/29/2016 Response Date: 09/01/2016 12:00 PM ET Classification Code: R499

NAICS Code: 541990

Contracting Office Address

Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E136, Rockville, MD 20850, UNITED STATES.

Description

National Cancer Institute (NCI), Division of Cancer Epidemiology and Genetics (DCEG), plans to procure on a sole source, data services on treatment-related second cancers after breast cancer from Kaiser Foundation Research Institute, 1800 Harrison St., 16th floor, Oakland, CA 94612-3416.

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 541990 and the business size standard is $15 million.

The period of performance is 12 months from date of award.

It has been determined there are no opportunities to acquire green products or services for this procurement.

Project Objectives: 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 and death, other second cancers.

Unique qualifications of the Contractor: The NCI previously contracted with Kaiser Foundation Research Institute (Kaiser) to develop a retrospective cohort of 3,643 breast cancer survivors (diagnosed 1994-2008, followed through 2011), using electronic medical records to study the late effects of hormonal and chemotherapy, particularly the risk of second cancers. This earlier contract collected data on diagnosis details, tumor characteristics, treatment, and other covariate information from electronic sources. The aim of the current procurement is to expand the scope and follow-up of this cohort to examine the relationship between radiotherapy techniques and risk of second cancers and to collect details on radiotherapy treatment from the Kaiser hard copy treatment summary reports that are not available in the electronic records. Thus the Kaiser group is the only group that can fulfill the current requirements. It was determined that this data source, with the existing breast cancer cohorts utilized in the previous Kaiser 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.

A managed care health plan is an excellent setting to study the questions in this procurement as they possess high quality treatment data (mostly stored electronically) for large numbers of women and these data can be linked to tumor registries for outcome information. The high quality medical record data available through Kaiser provides access to a unique and substantial cohort of women who are breast cancer survivors. The original electronic treatment records, combined with the detailed radiotherapy records provide a unique cohort in which to evaluate the relationship between radiotherapy dose and risk of second cancers, accounting for confounding by other treatments and some lifestyle factors such as obesity, hormonal (estrogen) use, and smoking history that are available in the medical records. The study design is significantly more efficient than the methods used in the previous case-control studies described above as a large proportion of the treatment data are available electronically and the physical medical record abstraction is from a central location rather than multiple clinics and hospitals.

Contractor Requirements:

The Contractor shall:

1. Secure local IRB clearance for this project and obtain all necessary HIPAA clearances.

2. Collaborate with NCI investigators to implement the study data collection tools and algorithms to successfully identify all data that are eligible for inclusion in this study.

3. Formation of breast cancer cohort using electronic records:

Conduct a search of the necessary databases to identify all primary female invasive breast cancer patients, with no prior invasive or in-situ cancer diagnoses, who were diagnosed at ages 18+ years with breast cancer between 1994 and 2014, inclusive, who survived at least one year following breast cancer diagnosis, age 18+ at breast cancer diagnosis, and who were members of KP-CO for at least 12 consecutive months during the study period (1994-2015, inclusive).

The Contractor shall update follow-up in existing cohort of female breast cancer survivors in women diagnosed between 1994 and 2008 with a first primary invasive breast cancer (age 18+ at breast cancer diagnosis, first primary of any site excluding non-melanoma skin cancers), who survived at least one year following initial diagnosis, and currently followed for outcomes through 2011 (outcomes in the existing cohort included breast cancer recurrence, all second and later order invasive or in-situ cancers, vital status and cause of death, and enrollment periods). The Contractor should extend this follow up through to 2015. In addition, the Contractor shall add to the current cohort additional patients who survived one year or more following a first primary invasive breast cancer diagnosed at ages 18+ years during from 2009 to 2014 with follow-up for all outcomes through December 31st, 2015. Women with a prior in-situ breast cancer and women with bilateral breast cancer at initial diagnosis shall be excluded.

Collect the following data, updated through December 31, 2015, when available in electronic databases:

3a. Tumor registry and demographics:

3a-i. Date of birth

3a-ii. Other information: race and race description, ethnicity

3a-iii. Tumor registry and demographic data for the study cohort

3a-iv. Breast cancer: date of diagnosis, method of diagnostic confirmation, histologic type, grade, laterality, stage (AJCC stage, Revision of AJCC stage (editions 1, 2, 3, 4)), summary stage, SEER staging, clinical and pathologic staging), ER status, PR status and HER2-neu status, tumor size, lymph node status, laterality, date of surgery, type of surgery, date of last tumor registry follow-up, and status at last tumor registry follow-up for all primary breast cancers.

3b. Enrollment

All entry and exit dates into the KP-CO system, allowing for a 60-day gap in membership.

3c. Cause of death

Date of death and cause of death.

3d. Other cancer outcomes

3d-i. All cancers recorded in the KP-CO Tumor Registry that occurred after the initial breast cancer diagnosis

3d-ii.Other cancer outcomes, including second, third and all subsequent cancers developing in the cohort: date of diagnosis, primary cancer site, histologic type, behavior code, grade, stage (AJCC stage, Revision of AJCC stage (editions 1, 2, 3, 4), summary stage, and SEER staging, clinical and pathologic staging), hormone receptor status for subsequent breast cancers (ER, PR, HER-2-neu status), status at end of follow-up.

3d- iii. Breast cancer recurrence and death: date of recurrence, type of recurrence/location of recurrence, date of death, status at end of follow-up

3e. Mammograms:

Date and type (screening or diagnostic) of all mammograms shall be sent for all women diagnosed through the end of the study (12/31/2015).

3f. Chemotherapy and Immunotherapy:

3f-i. Prescriptions for chemotherapy and immunotherapy, including dates of prescriptions, brand and generic name of drug, generic product identifier, days supplied, route of chemotherapy, strength/dose of drug, procedure code of drug, reason for drug prescription (in particular, if methotrexate is given for arthritis). These will be identified from the pharmacy database and procedure codes and includes all prescriptions for chemotherapy after breast cancer diagnosis including chemotherapy for recurrent/metastatic breast cancer during the study period until Dec 31, 2015.

3f-ii. Pharmacy drug administration

Hormonal therapy treatments: dates of all prescriptions of hormonal therapy dispensed, including formulation, product name, generic name, duration/number of days, quantity dispensed, and pharmacy codes during the study period until Dec 31, 2015.

3f-iii. Goserelin/leuprolin use, estrogen and progesterone use: dates of all prescriptions dispensed, including product name, generic name, duration/number of days and pharmacy codes during the study period.

3f-iv. Selective serotonin reuptake inhibitors (SSRIs): dates of all prescriptions of SSRIs dispensed, including product name, generic name, duration/number of days and pharmacy codes during the study period until Dec 31, 2015.

3f-v. Other potential tamoxifen inhibitors: dates of all prescriptions of other tamoxifen inhibitors dispensed, including product name, generic name, duration/number of days and pharmacy codes during the study period. List of specific drugs will be provided by NCI investigators.

3g. Radiology

Radiotherapy treatment: dates of treatment, identified from the tumor registry.

3h. Smoking status

All dates where smoking status was recorded in data sources. Smoking status shall be captured for 1 year prior to breast cancer diagnosis through the end of study.

3i. Vitals

Height and weight data and date of measure for any measure on electronic database, both prior to breast cancer diagnosis and subsequent to breast cancer diagnosis.

3j. History of all surgeries for removal of the ovaries (oophorectomy) and/or removal of the uterus (hysterectomy) from electronic databases, including the period of enrollment both before and subsequent to the first invasive breast cancer diagnosis until the end of follow-up or Dec. 31, 2015

3k. Other additional variables agreed by the Contractor and the NCI investigators.

4. Radiotherapy summaries for cohort and case-control study:

4a Cohort: The Contractor shall retrieve radiotherapy summaries for women treated with radiotherapy, n=2254, among the existing cohort of breast cancer patients diagnosed 1994-2008 and followed through 2011. 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 will 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. [This procurement will not capture radiotherapy summaries for breast cancer patients diagnosed 2009-2014, except as specified below for the CBC.]

4b. CBC Case-control study: For breast cancer patients diagnosed 2009-2014 (followed through 2015) in the study extension who develop a CBC 5 or more years after their initial breast cancer diagnosis and for 5 year survivors in the original cohort (1994-2008) who developed a CBC during 2012 -2015, and for matched controls, this Contractor will also provide scanned radiotherapy summaries (an estimated 40 cases and 120 control patients (3 per case)).

NCI will provide the Contractor will a file containing the patients by ID only for whom radiotherapy summaries are to be obtained.

5. Conduct the necessary and sufficient quality control/quality assurance examinations to confirm the completeness and accuracy of the data. This may include detailed review of archive medical records, but any such review would be limited in size and scope and would include only a small percentage of all breast cancer patients who are eligible to be included in the cohort. Data quality checks will be conducted by year to identify possible quality issues in data, especially prior to 2000.

6. Assemble study datasets that include data listed above, with all data identified only by unique study identification number. All data shall be delivered to Information Management Services (Rockville, MD).

7. Provide specific analytic coding schema, programs and supporting information.

B. Contractor Qualifications The Contractor shall be required to have access to the Kaiser Permanente Colorado electronic data files, including tumor registry files, prescription drug files, files of procedures performed while enrolled in the Kaiser plan, and other KP-CO medical and data files as described above in this procurement and to radiotherapy summary reports, as needed to meet the requirements of this Statement of Work.

C. Reporting Requirements and Deliverables Technical Progress Reports: Quarterly Progress Reports shall describe 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 (Rockville, MD) and to NCI using a secure, password-protected file transfer service maintained by Kaiser Permanente. 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 provide the scanned radiotherapy summary reports described above in batches, together with an excel file detailing the contents (ID, date of breast cancer diagnosis) of each batch.

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 the NCI to determine if the party can perform the requirement. Responses must be received in the contracting office by 12 PM ET, on September 1, 2016. All responses and questions must be via email to Francisco Mendoza, Contracting Specialist at francisco.mendoza@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 through SAM.GOV and have Representations and Certifications filled out. Reference: N02CO62688-78 on all correspondence.