Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E136, Bethesda, MD 20892, UNITED STATES

Description
The National Cancer Institute (NCI), Division of Cancer Epidemiology (DCEG), Metabolic Epidemiology Branch (MEB) plans to procure on a sole source basis, services to enroll 180 cases and 180 controls in the ongoing THINKER Case-Control Study of esophageal squamous cell carcinoma (ESCC). These activities are coordinated by the Contractor World Gospel Hospital; 3783 E State Road 18, Marion, IN, 46952-8768.

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.

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

BACKGROUND

Esophageal squamous cell carcinoma (ESCC) is common in the developing world, and it is a leading cancer diagnosis in Western Kenya. Tenwek Hospital is a 300-bed mission hospital located in Bomet, Kenya, approximately 200 miles northwest of Nairobi. Tenwek serves as a primary health care facility for approximately 400,000 people within a 50 km radius of the hospital, and it has become a referral center for a broader population. ESCC is the most common malignancy seen at Tenwek Hospital, and the patients show a very unusual age distribution, with about 8% of cases diagnosed at ≤ 30 years of age.

The NCI's long-term goal is to understand the risk factors and pathogenesis of ESCC in Western Kenya, and to establish effective screening and prevention programs there. To accomplish these objectives, the NCI has designed and begun recruitment for a case-control study at Tenwek Hospital in Bomet, Kenya, where all research activities are coordinated by the Contractor. This case-control study, called the THINKER Study, is designed to recruit a total of 300 ESCC cases presenting to the hospital and 300 hospital in-patients who do not have ESCC as controls. Currently, 120 cases and 120 controls have been recruited and enrolled, funded by another mechanism, so the current procurement will pay for the recruitment of the remaining 180 cases and 180 controls. All subjects recruited will complete a risk factor questionnaire and provide saliva, blood, and urine samples. In addition, the 180 ESCC cases will undergo an endoscopy examination and biopsies of their esophagus. The final results of this study will describe risk factors for ESCC in this population, providing, for the first time, clues as to the etiology of ESCC in this population.

On completion of the case-control study, an additional 180 ESCC cases will be invited to contribute a saliva sample and complete a brief (one page) questionnaire. These additional samples will contribute additional statistical power to a genome wide association study (GWAS) of ESCC in Africa.

OBJECTIVE

The objective of this procurement is to complete case and control enrollment in the THINKER Case-Control Study of ESCC at Tenwek Hospital in Bomet, Kenya (where research activities are coordinated by the Contractor). An additional 180 ESCC patients will also be invited to contribute a saliva sample and complete a brief (one page) questionnaire to contribute additional power to a GWAS study of ESCC in Africa.

SCOPE

The field team at Tenwek Hospital will enroll 180 ESCC cases and 180 controls using an mHealth platform which uploads enrollment and questionnaire data in real time. All participants will complete questionnaires about their demographics, usual diet, occupation, home and habits. In addition, both cases and controls will be asked to provide saliva, urine and blood samples, and cases will also provide a tumor biopsy and a biopsy of endoscopically normal-appearing mucosa. The samples will be processed, frozen onsite, and shipped to the NCI biorepository at the end of the study. An additional 180 ESCC patients will be invited to contribute a saliva sample and complete a brief (one page) questionnaire in order to contribute additional power to a genome wide association study of ESCC in Africa.

CONTRACT REQUIREMENTS

The Contractor shall:

1.1 Provide questionnaire information on 180 ESCC cases and 180 controls, recorded and uploaded in real time using the mHealth platform previously developed by the NCI and the Contractor;

1.2 Collect saliva, urine and blood samples from 180 ESCC cases and 180 controls, and tumor and normal tissue samples from 180 ESCC cases. The Contractor will process the samples immediately and freeze them on site, for delivery to the NCI biorepository at the end of the study;

1.3 Deliver a brief protocol outlining the plan and Standard Operating Procedures (SOPs) for the Case-Control study; and

1.4 Provide brief questionnaire information and a saliva sample from an additional 180 ESCC cases.

TYPE OF ORDER

This is a nonseverable Firm Fixed Price Purchase Order.

The services specified in each contract line item (CLIN) have been determined to be nonseverable services - a specific undertaking or entire job with a defined end product of value to the Government.

PERIOD OF PERFORMANCE

The period of performance shall be 12 months from the purchase order award date.

PLACE OF PERFORMANCE

The place of performance will be Tenwek Hospital, Bomet, Kenya, whose research activities are coordinated and managed by the Contractor.

REPORT(S)/DELIVERABLES AND DELIVERY SCHEDULE

DELIVERABLE DELIVERABLE DESCRIPTION / FORMAT REQUIREMENTS DUE DATE
#1 Protocol plan in Word or PDF format sent to NCI TPC 30 days after award
#2 Complete questionnaire data as delivered via the mHealth platform previously developed by the NCI and the Contractor. 30 days after the enrollment of final case/control
#3 360 saliva samples
360 urine samples
360 blood samples
180 esophageal tumor samples
180 normal esophageal tissue samples 30 days after the enrollment of final case/control
#4 Brief questionnaire data from an additional 180 ESCC cases 30 days after the enrollment of final case
#5 180 saliva samples from additional ESCC cases 30 days after the enrollment of final case

Tenwek Hospital and the proposed Contractor World Gospel Mission, which coordinates and manages all research activities at Tenwek Hospital are uniquely qualified to undertake the completion of this case-control study of esophageal cancer, because they have already enrolled the first 120 cases and 120 controls of this study (funded through a previous subcontract), and the remaining 180 cases and 180 controls need to be enrolled using the same methods in the same population. Tenwek Hospital is situated within a high incidence region of esophageal squamous cell cancer and sees approximately 6 ESCC cases each week. Tenwek Hospital and the Contractor, the World Gospel Mission has built a highly trained research team who can consent, enroll, and interview patients, and take, process and store biospecimens. World Gospel Mission and Tenwek Hospital has worked with NCI to develop the mHealth platform that is used in this study, which allows real-time access (by NCI) to the study data. Based on the information above, World Gospel Mission is the only known Contractor to perform the services outlined in the Statement of Work.

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 July 24, 2019. All responses and questions can be emailed to Kimesha Leake, Contracting Officer via electronic mail at [email protected]. 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: 75N91019Q00097 on all correspondence.