Association of sex steroid hormones and gallbladder cancer in Women

Contracting Office Address

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

1.0    DESCRIPTION
 
The Division of Cancer Epidemiology and Genetics (DCEG) plans to procure services, on a sole source basis, from Universite Laval, Pavillon Des Sciences De L'EDUCATION, Room 1434, 2320 Rue Des Bibliotheques, Quebec, Qc G1V 0A6, Canada.
2.0    BACKGROUND

Gallbladder cancer (GBC) has a female predominance with a worldwide female‐to‐male incidence rate ratio of 2:1. This sex disparity suggests that sex hormones may be involved in carcinogenesis. Several studies have shown that reproductive factors (proxies for endogenous hormone levels) among premenopausal women are associated with an increased risk of GBC. Estradiol is a primary sex steroid hormone that regulates diverse biological processes and is critical for reproduction and hepato-biliary secretion. In postmenopausal women the main source of estrogen in circulation is from conversion of androgens to estrogens in adipose tissue due to aromatase. The lithogenic effect of estradiol is dose-dependent and acts by upregulating the expression of estrogen receptor-α (ERα). Estradiol increases hepatic output of newly synthesized cholesterol, resulting in increased transfer of cholesterol to bile, increasing the risk of in chronic inflammatory gallbladder disease. Chronic inflammation of the gallbladder causes epithelial regeneration with metaplasia to subsequent development of dysplasia, carcinoma in situ, and invasive carcinoma. The progression from metaplasia to dysplasia may be sex hormone dependent. The overexpression of progesterone and estrogen receptors has been observed in studies of GBC. Progesterone receptor expression was seen in a higher proportion of cases with metaplasia compared to those without metaplasia and higher ER expression was seen in malignant lesions compare to benign lesions. However, no previous study has examined the role of pre-diagnostic circulating sex steroid hormones and the development of GBC. The sex-steroid hormone assay includes the following metabolites: estradiol, estrone, progesterone, testosterone, dehydroepiandrosterone, androstenedione, and dihydrotestosterone. This assay will allow the Division of Cancer Epidemiology and Genetics (DCEG) to examine the association between sex hormones and GBC. 

2.1    OBJECTIVE

The NCI requires the use of the sex-steroid hormone assay. The NCI proposes to test 695 samples. Total number of test samples will be performed across the base and option years.

3.0    SCOPE

The NCI proposes to test 695 samples using the sex-steroid hormone assay at Université Laval. 

4.0    CONTRACT REQUIREMENTS/ AND PERSONNEL QUALIFICATIONS 

The Contractor shall perform the following:

4.1    Tasks

4.1.1    Run the sex steroid hormone assay on biospecimens
4.1.2    Deliver the test results to the NCI in an electronic encrypted file
4.1.3    Return residual samples to NCI
NCI will arrange shipment of these samples to and from the Contractor.  

5.0    TYPE OF ORDER

This is a firm fixed-price purchase order.

6.0    NON-SEVERABLE SERVICES

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

7.0    PERIOD OF PERFORMANCE

The anticipated period of performance is: 

Base year: August 7, 2023 – August 6, 2025

8.0    PLACE OF PERFORMANCE

The services executed under this contract shall be performed at the Contractor’s facility

9.0    REPORT(S)/DELIVERABLES AND DELIVERY SCHEDULE

All written deliverables shall be sent electronically to the NCI Technical Point of Contact (TPOC), TBD at award, in appropriate formats (including but not limited BAM, CRAM, VCF, Excel, DOC, CSV, PDF, PNG, etc.) unless approved by the TPOC in accordance with the deliverable schedule below. The TPOC shall review the contents of all draft deliverables. If no comments or requests for revisions are provided to the Contractor within 30 business days, the deliverables shall be considered acceptable. If revisions are required, NCI shall respond to the Contractor within five (5) business days of receiving the deliverable, specifying the required changes/revisions. Final copies of approved drafts shall be delivered to the NCI TPOC within five (5) business days after receipt of the Government’s comments.

The TPOC for this order is:

(TBD)

DELIVERABLE     DELIVERABLE DESCRIPTION / FORMAT REQUIREMENTS    DUE DATE
4.1.1    Sex steroid hormone assay    6 months from the date that NCI samples are received Université Laval laboratory
4.1.2    Test results in an electronic encrypted file     6 months from the date that NCI samples are received Université Laval laboratory
4.1.3    Return of residual samples    6 months from the date that Task 4.1.2 is delivered

10.0    INSPECTION AND ACCEPTANCE CRITERIA

Pursuant to FAR clause 52.212-4, all work described in the SOW to be delivered under this contract is subject to final inspection and acceptance by an authorized representative of the Government. The authorized representative of the Government is the NCI TPOC, TBD, who is responsible for inspection and acceptance of all services, materials, or supplies to be provided by the Contractor.
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. Remediation of any materials that do not comply with the applicable Section 508 requirements as set forth below, shall be the responsibility of the Contractor.
Products, platforms and services delivered as part of this work statement that are ICT, or contain ICT, must conform to the Revised 508 Standards, which are located at 36 C.F.R. § 1194.1 & Apps. A, C & D, and available at https://www.access-board.gov/guidelines-and- standards/communications-and-it/about-the-ict-refresh/final-rule/text-of-the-standards- and- guidelines.
Per Section 508 and as mandated under HHS Policy for Section 508 Compliance and Accessibility of Information and Communications Technology (ICT) (07/2020) all documents or electronic files provided to the NIH NCI under contract must be conformant with Section 508 standards and accessible to persons with disabilities. Conformance shall be confirmed by use of material provided at HHS OS Factsheets & Reference Guides and verified through the use of the HHS Checklist Documents (WCAG 2.0 Refresh); in addition, contractors and vendors are encouraged to make use of the instructional materials and checklists at GSA Section 508.gov’s Create Accessible Digital Products.

11.0    UNIQUE QUALIFICATIONS OF THE CONTRACTOR

The Université Laval is the only laboratory that has the sex steroid hormone assay needed to complete the project. This lab been used by DCEG for other projects examining sex hormones and cancer. This laboratory is the only source capable of meeting our scientific requirements. It is critical to use the same laboratory, equipment, sample handling approach, quality control approach, and data processing to ensure the scientific comparability of the new data with the previous studies conducted by researchers within DCEG (e.g., studies by Brinton et al. 2015 [PMC4461805], Petrick et al. 2018 [PMC5771564], and Petrick et al. 2020 [PMC7391790. Any deviation from the proposed acquisition strategy would result in the NCI being unable to compare these results to previous results. Other testing services offer hormones or require a larger sample volume for the same hormone panel. Thus, the continued use of Université Laval is needed to meet the needs of NCI at this time.

12.0    SUBMISSION INSTRUCTIONS

This notice is not a request for competitive quotations. However, if any interested party believes it can meet the above requirements, 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 NCI to determine if the party can perform the requirement.  All responses and questions must be sent via email to the Contract Specialist, Dana Summons, at dana.summons@nih.gov by no later than 3:00 PM EST on August 2, 2023, (8/2/23). 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. Reference: 75N91023Q00137 on all correspondence.