SOW_DRAFT 01.15.25.pdf

Statement of Work Draft

A. INTRODUCTION/BACKGROUND:

The Laboratory of Human Carcinogenesis (LHC), a laboratory with a record of assays that are designed for clinical application, uses integrative biology and translational research strategies to investigate the molecular epidemiology of human cancer.

B. SCOPE AND TASKS:

As a resource provider to address scientific questions concerning the initiation of cancer in humans, the contractor shall be responsible for: 1) identifying and recruiting cancer cases and population‐based controls and obtaining signed informed consent from potential participants, 2) collecting, storing, processing, and deidentifying biological specimens to the LHC, 3) collecting, storing, processing, and de‐ identifying participant interview data, and 4) obtaining and maintaining ethical and legal approvals, including but not limited to local Institutional Review Board (IRB) approvals. Please see References #1‐ #3 listed on the References Section of this Statement of Work for further information on the current project.

Personnel that interact with patients must be trained in phlebotomy, laboratory safety with an emphasis on Biohazard training, Protected health information (PHI) training and Health Insurance Portability and Accountability Act of 1996 (HIPAA) training.

Independently and not as an agent of the Government, the contractor shall supply all labor, materials, facilities, equipment, and supplies to perform the following tasks:

1. Patient Accrual:

The Contractor shall:

1.a. Accrue a goal of up to 100 lung cancer cases per year. Provide a completed questionnaire administered to each cooperative enrollee including all relevant information available in the individual medical records. Collect malignant tissue specimen and adjacent, uninvolved normal tissues from each enrolled patient that goes to surgery. Collect whole blood, plasma, serum, buffy coat (a cheek swab may be collected if a blood draw is not possible), nasal swab and urine specimen from all cancer patients.

1.b. Accrue a goal of up to 40 benign lung nodules from surgery cases per year. Provide a completed questionnaire administered to each cooperative enrollee including all relevant information available in the individual medical records. Collect affected tissue specimen and adjacent, uninvolved normal tissues from each enrolled patient that goes to surgery. Collect whole blood, plasma, serum, buffy coat (a cheek swab may be collected if a blood draw is not possible), nasal swab and urine specimen from all surgical patients.

1.c. Accrue a goal of up to 200 low‐dose computed tomography (LDCT) screened candidates per year.

Any patient with a Lung‐RADS score of between 0 and 5 attending a nodule clinic will be eligible to enroll in the study. Collect, blood, urine and nasal swabs at the time of enrollment and ask patients to complete a detailed questionnaire (as in the case control study). Follow patients that are sent for further diagnostic work‐up and collect tissue where possible. Collect additional blood, urine and nasal swab biospecimens when patients re‐present for screening and administer a follow‐up questionnaire to assess current smoking status and weight.

1.d. Accrue a goal of up to 100 primary hepatocellular liver carcinomas (HCC) cases per year. Provide a completed questionnaire administered to each cooperative enrollee including all relevant information available in the patients’ medical records. Abstract enrollee’s medical records on an annual basis until they are deceased. Collect malignant tissue specimens and adjacent, uninvolved normal tissue from each enrolled cancer patient that goes to surgery. Collect whole blood, plasma, serum, buffy coat, cheek swab (if blood draw is not possible), and a urine specimen from each enrolled subject.

1.e. Accrue a goal of up to 150 chronic liver disease (CLD) cases per year. Provide a completed questionnaire administered to each cooperative enrollee including all relevant information available in the patients’ medical records. Abstract enrollee’s medical records on an annual basis until a cancer diagnosis. Collect whole blood, plasma, serum, buffy coat, cheek swab (if blood draw is not possible), and a urine specimen from each enrolled subject. Collect malignant tissue specimens and adjacent, uninvolved normal tissue from each enrolled participant that subsequently develops cancer and goes to surgery. Follow patients that are sent for further diagnostic work‐up and collect tissue where possible.

Collect additional blood, urine and nasal swab biospecimens when patients re‐present for screening and administer a follow‐up questionnaire.

1.f. Accrue a goal of up to 100 primary pancreatic ductal adenocarcinoma cases per year. Provide a completed questionnaire administered to each cooperative enrollee including all relevant information available in the individual medical records. Collect malignant tissue specimens and adjacent, uninvolved normal tissue from each enrolled cancer patient that goes to surgery. Collect whole blood, plasma, serum, buffy coat, cheek swab (if blood draw is not possible), and a urine specimen from each enrolled subject.

1.g. Accrue a goal of up to 50 chronic pancreatitis cases per year. Provide a completed questionnaire administered to each cooperative enrollee including all relevant information available in the individual medical records. Collect inflamed tissue specimens and adjacent, uninvolved normal tissue from each enrolled patient that goes to surgery. Collect whole blood, plasma, serum, buffy coat, cheek swab (if blood draw is not possible), and a urine specimen from each enrolled subject.

1.h. Accrue a goal of up to 40 breast cancer patients scheduled for surgery per year. Collect blood at the time the patient consents to participate. Collect malignant tissue specimens and adjacent, uninvolved normal tissue if the patient goes to surgery. Administer a short survey at a follow‐up clinic visit post‐ surgery and collect a second blood sample. Alternatively, visit the patients at their home for the interview and blood collection.

1.i. Accrue a goal of up to 225 normal population control subjects per year (non‐cancerous, healthy population) recruited for these studies who are US citizens, as dictated by the characteristics required to match them with cancer patients recruited as participants into the various studies. Collect whole blood, plasma, serum, buffy coat (a cheek swab may be collected if a blood draw is not possible), nasal swab and urine specimen from each participant. Maintain and use these records for matching to the case‐ control participants by age/gender/race/zip code.

file://nciis-p401.nci.nih.gov/group02/Rcb/ETSBPUB/ETSB%20Rukshani%20Levy/Acquisitions/FY-2020/UMD%20Recomp/TAB%20B%20-%20PRE-SOLICITATION/2_ACQUISITION%20PLAN/Attachment%201%20-%20SOW/)(Refernece

1.j. Accrue cancer patients willing to participate in research but who do not qualify for specific aforementioned studies. Patients may also have a cancer originating in a site other than that collected in the case‐control studies (e g., esophagus, colon, stomach, etc.). Use the questionnaire administered for lung cancer cases to interview these cancer cases that do not fall specifically into a case‐control study. Collect Surgical tissue as well as plasma, serum, buffy coats, cheek swabs, nasal swabs, and urine from patients.

2. Biological Sample Collection:

The Contractor Shall:

Administer an NCI‐developed interview to each participant for the collection of basic demographic information, smoking history, family history of cancer, medications, occupational history, for use in epidemiological studies (see 3. Data Requirements). At the time of interview, the Contractor shall:

Collect and store all specimens (tissues, blood products, urine, nasal swabs, cheek swabs, etc.) from either cases or controls in plastic vials of appropriate size.

Collect, when possible, from each case, non‐adjacent normal and tumor tissues. Prepare paraffin embedded tissues for tumor and non‐involved tissue from all cancer cases.

Collect and process two vacutainers for serum and up to four vacutainers for plasma and lymphocyte preparation from all participants (including population‐based controls) at the time of interview.

Collect and process an oral mouthwash rinse for cheek cells if a blood‐draw is not possible.

Collect up to 50 ml of urine from each participant.

Deliver fresh tissues on wet ice within 3 hours after receiving the specimen from the pathologist to be sent to the NCI/LHC and/or cryo‐preserved at ‐80°C.

Deliver frozen biological specimens that have been stored at ‐80°C to NCI/LHC as a batch bimonthly. Human samples containing or suspected of containing infectious substance shall be packaged and handled in accordance with applicable government regulations (Reference #4).

Characterize and histologically classify both cancerous and non‐cancerous solid tissues delivered to the NCI. Provide the diagnosis, stage, grade, and tumor, node, metastasis status from pathology reports generated by the physician and the pathologist for individual cases as well as other pertinent classifications (i.e. ER status, viral load) where indicated or as specified by the COR. When requested by the COR, provide stained and/or unstained histological sections from paraffin embedded tissues from cancer cases from the project. There will be a request for approximately 3,400 histology slides per year.

Ensure that the Information delivered to Government personnel is void of any personally identifiable health information on the cases or the controls (Reference #5)

3. Data Requirements:

The Contractor shall:

Provide an epidemiology profile from an NCI‐developed questionnaire, administered by trained interviewers via informed consent from each participant. Conduct Interviews in the field using government provided electronic tablets as a collection tool.

Store and maintain the computerized profiles of the participants (without personal identifiers) in a tissue‐ donor epidemiology database, secured according to the Privacy Act requirements. Privacy Act Statement of Record Number (SORN) 09‐25‐0200 is applicable to the requirements of this Statement of Work (Reference #6).

Provide secure storage of completed questionnaires and up‐to‐date security for all electronic data, especially of those data containing personal identifiers in the contractor's facility. Databases must be covered under a Federal Information Security Management Act Authority to Operate (FISMA ATO) Letter.

Provide data abstracted from Medical Records of participants as requested by the COR.

Prepare, request, and store data for selected cases in the study for survival searches per the National Death Index (Reference #7) as required by the LHC investigators and requested by the COR. Merge and appropriately clean Individual patient questionnaire data before transfer (without PHI) to the LHC.

Report all recruitment and essential contract activities to the managing NCI/LHC investigators in written form, in preparation for and to be discussed verbally during regularly scheduled Conference Calls established by the COR. The contractor's Principal Investigator and the NCI/LHC Principal Investigators may attend the calls as determined by the COR.

Document as requested, both the number of patients targeted as potential participants in the patient accrual and specimen collection efforts for case‐control studies of cancers of the lung, liver, breast and pancreas as well as the number of patients admitted to the studies.

4. Transition Activities:

Phase-In (for non-incumbent Contractor only):

The draft Phase‐In plan submitted with the proposal shall be revised, if necessary, and shall become the final Phase‐In Plan upon approval of the COR.

The Phase‐In plan shall describe the steps to ensure that:

a. Staff are oriented, trained and available to assume all tasks described in the SOW.

IRB approval is provided from the Host institution.

b. Documentation for FISMA ATO approval is provided.

c. Archived tissue blocks, patient questionnaires, and medical record abstracts (without PII) from the incumbent are received.

d. Standard Operating Procedures (SOPs) will be provided to the COR for review and approval.

Phase-Out:

The Phase‐Out plan shall facilitate the accomplishment of a seamless transition from the incumbent to the successor contractor or Government personnel prior to the end of the contract. The work shall include transfer of all data and specimens to the successor contractor or Government personnel.

The Contractor shall develop and submit a draft Phase‐Out plan, which shall describe the contractor strategy for transferring work from this contract to a successor contract. The draft plan will be revised as needed and shall become the final Phase‐Out plan upon approval of the COR prior to contract expiration. The plan shall include a system for transfer of policies and procedures; transfer of relevant files, records, materials, specimens and data;

transition of all activities, as appropriate.

The Contractor shall provide the successor Contractor or Government personnel with detailed briefings regarding the policies and procedures for managing all aspects of the project. As part of these detailed briefings, the Contractor shall provide the successor Contractor or Government personnel with all documentation of processes and products, which shall include, but not be limited to, SOPs, materials, training materials, presentations on activities and samples.

5. Ethical and Legal Approvals:

The Contractor shall:

Maintain approvals for the accrual of subjects and operation of the project in accordance with the local Internal Review Board (IRB), Privacy Act, HIPAA regulations, Good Clinical Practices (GCP), FISMA, phlebotomy training, and laboratory safety with an emphasis on biohazard training. More details can be found by using the links provided in Reference #8.

6. Section 508 Accessibility Requirements

Section 508 of the Rehabilitation Act, as amended by the Workforce Investment Act of 1998 (P.L.

105‐ 220) requires that when Federal agencies develop, procure, maintain, or use information and communication technology (ICT), it shall be accessible to people with disabilities. Federal employees and members of the public who have disabilities must have access to, and use of, information and data that is comparable to people without disabilities.

Products, platforms and services delivered as part of this SOW that are ICT, or contain ICT, must conform to the Revised 508 Standards, which are located at 36 C.F.R. § 1194.1 & Appendices A, C and D, and available at https://www.access‐board.gov/ict/ .

All deliverable products provided shall be in compliance with Section 508 requirements. The references provided under Reference #9 for Guidelines for preparation of compliant products and HHS checklists shall be used to ensure that deliverable products are in compliance with these guidelines.

https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-ict-refresh/final-rule/text-of-the-standards-and-guidelines https://app.buyaccessible.gov/ict-accessibility#e301_1 http://app.buyaccessible.gov/ict-accessibility#e205_1_general https://app.buyaccessible.gov/ict-accessibility#e302_1 https://app.buyaccessible.gov/ict-accessibility#e302_1 https://app.buyaccessible.gov/ict-accessibility#e302_1 https://app.buyaccessible.gov/ict-accessibility#e302_1 https://app.buyaccessible.gov/ict-accessibility#e302_1 https://www.access-board.gov/ict/

REFERENCES:

1. The initial publication describing the lung cancer studies, including inclusion and exclusion criteria, matching criteria, etc.:

Zheng YL, Loffredo CA, Yu Z, Jones RT, Krasna MJ, Alberg AJ, Yung R, Perlmutter D, Enewold L, Harris CC, Shields PG. Bleomycin-induced chromosome breaks as a risk marker for lung cancer: a case-control study with population and hospital controls. Carcinogenesis. 2003 Feb; 24(2):269‐74.

2. An overview of the project design:

https://ccr.cancer.gov/laboratory‐of‐human‐ carcinogenesis

3. Descriptions of the clinical aspects of the lung and liver components:

a. https://clinicaltrials.gov/ct2/show/NCT00339859

b. https://www.clinicaltrials.gov/ct2/show/NCT00913757

4. Regulations for shipping human samples on dry ice:

https://www.iata.org/whatwedo/cargo/dgr/Documents/packing‐instruction‐650‐DGR56‐en.pdf

5. Description of HIPAA guidelines: https://www.hhs.gov/hipaa/for‐professionals/index.html

6. System of Records Number 09‐25‐0200:

https://www.federalregister.gov/documents/2002/09/26/02‐23965/privacy‐act‐of‐1974‐ annual‐publication‐of‐systems‐of‐records.

7. National Death Index:

https://www.cdc.gov/nchs/ndi/?CDC_AA ref_Val=https://www.cdc.gov/nchs/ndi/i ndex.htm

8. Information concerning Ethical and Legal Approvals:

a. https://www.hhs.gov/ohrp/regulations‐and‐policy/requests‐for‐comments/guidance‐for‐ institutions‐and‐irbs/index.html

b. https://www.justice.gov/opcl/privacy‐act‐1974

c. https://ichgcp.net/

d. https://csrc.nist.gov/publications

9. Section 508 Accessibility Requirements:

a. https://www.access‐board.gov/ict/

b. https://www.hhs.gov/web/section‐508/accessibility‐checklists/index.html https://ccr.cancer.gov/laboratory-of-human-carcinogenesis https://ccr.cancer.gov/laboratory-of-human-carcinogenesis https://clinicaltrials.gov/ct2/show/NCT00339859 https://www.clinicaltrials.gov/ct2/show/NCT00913757 https://www.iata.org/whatwedo/cargo/dgr/Documents/packing-instruction-650-DGR56-en.pdf https://www.hhs.gov/hipaa/for-professionals/index.html https://www.federalregister.gov/documents/2002/09/26/02-23965/privacy-act-of-1974-annual-publication-of-systems-of-records https://www.federalregister.gov/documents/2002/09/26/02-23965/privacy-act-of-1974-annual-publication-of-systems-of-records https://www.cdc.gov/nchs/ndi/?CDC_AAref_Val=https://www.cdc.gov/nchs/ndi/index.htm https://www.cdc.gov/nchs/ndi/?CDC_AAref_Val=https://www.cdc.gov/nchs/ndi/index.htm https://www.cdc.gov/nchs/ndi/?CDC_AAref_Val=https://www.cdc.gov/nchs/ndi/index.htm https://www.hhs.gov/ohrp/regulations-and-policy/requests-for-comments/guidance-for-institutions-and-irbs/index.html https://www.hhs.gov/ohrp/regulations-and-policy/requests-for-comments/guidance-for-institutions-and-irbs/index.html https://www.justice.gov/opcl/privacy-act-1974 https://ichgcp.net/ https://csrc.nist.gov/publications https://www.access-board.gov/ict/ https://www.hhs.gov/web/section-508/accessibility-checklists/index.html

REFERENCES: