Identification of Biomarkers of Radiation Exposure in Radon Cohorts

Solicitation Number: 1000210157

1. The Purpose and Explanation of an ACAN

An Advance Contract Award Notice (ACAN) allows Health Canada to post a notice for no less than fifteen (15) calendar days, indicating to the supplier community that a goods, services or construction contract will be awarded to a pre-identified contractor. If no other supplier submits, on or before the closing date, a Statement of Capabilities that meets the minimum requirements identified in the ACAN, the Contracting Authority may then proceed to award a contract to the pre-identified contractor.

2. Rights of Suppliers

Suppliers who consider themselves fully qualified and available to provide the services or goods described in this ACAN may submit a Statement of Capabilities demonstrating how they meet the advertised requirement. This Statement of Capabilities must be provided via e-mail only to the contact person identified in Section 12 of the Notice on or before the closing date and time of the Notice. If the Bidder can clearly demonstrate they possess the required capabilities, the requirement will be opened to electronic or traditional bidding processes.

3. Proposed Contractor

CARTaGENE, CHU Sainte-Justine, Université de Montréal, 3175 chemin de la Cote-Sainte-Catherine, Montréal, QC H3T 1C5

4. Definition of Requirements or Expected Results

The National Radon Program under the Radiation Health Assessment Division has a mandate to provide Canadians with evidence-based guidance to support the optimal application of radiation protection practices.The objective of this HC Research Ethics Board approved project (HC REB 2017-0026) will be to conduct a pilot study investigating the biological effects in high radon exposed individuals that would provide insights into the mechanistic pathways that cause radon induced lung cancer.CARTaGENE is part of the Canadian Partnership for Tomorrow's Project ( CPTP) which is the largest longitudinal study of its kind ever undertaken in Canada following the health of 300,000 people for 30 years in the Provinces of British Columbia, Alberta, Ontario, Quebec, and in Atlantic Canada. This national study is investigating how genetics, the environment, lifestyle, and behavior contribute to the development of chronic disease.

CARTaGENE is a public research platform of the Centre hospitalier universitaire Sainte-Justine created to accelerate health research under the CPTP. CARTaGENE consists of both biological samples and health data from 43,000 Québec residents aged between 40 to 69 years from six metropolitan areas where 70% of Quebecers reside. Participants include residents from Montreal, Quebec , Sherbrooke, Saguenay, Gatineau and Trois Rivieres which presents a good opportunity for greater geographic coverage representative of the target population to find radon potential areas to support the pilot study . Since this cohort has a more detailed questionnaire that collects information about the residential and occupational exposures to various environmental parameters, it will be an added benefit to the study design. In addition, there is provision to collect fresh blood instead of stored blood which has a significant advantage from a biological assessment standpoint.Hence, there are many advantages for selecting the Quebec cohort of the CPTP for the pilot phase of this research study.CARTaGENE has established a platform for researchers to access their bio-banked samples; now and decades into the future to better treat and prevent cancer and chronic disease. By collecting health data and information through online questionnaires, physical measures and blood samples, CARTaGENE provides researchers with a rich resource to investigate the complex interplay between genetics, lifestyle, environment and health. This study will be the first of its kind undertaken where a series of biological endpoints will be examined in individuals exposed to indoor residential radon levels. Data generated from this work will provide new knowledge on chronic low dose exposure to radon and radon progeny that will be shared with the scientific community, as well as providing the foundation for expanding to other CPTP cohorts.

The objective of this contract is to conduct a pilot radon biomarker identification study with CARTaGENE under the HC-REB-2017-0026 approved study protocol. The purpose of the pilot project will be to gauge the potential for new and existing technologies to identify biomarkers of chronic exposure to indoor radon levels.

Health Canada needs the services of the Contractor (CARTaGENE) to fulfill the following research objectives:

1. Engage and contact 3400 participants from the CARTaGENE cohort to seek interest for recruitment in the radon biomarker study.
2. Provide access to health data from baseline and follow-up questionnaires to identify study participants within a pre-determined age group, without confounding traits/habits in order to meet the inclusion/exclusion criteria.
3. Provide access to fresh or stored blood samples for participants that meet the inclusion/exclusion criteria (n=252).

   This pilot study will provide the opportunity to test new “omics” technology along with various statistical modelling approaches to identify valid biomarkers that will help in generating new knowledge about the biological effects from radon exposure. The information generated from the study will contribute to the body of evidence under consideration by the scientific organizations that are responsible for the international radiation protection framework.

   Radon is the second leading cause of lung cancer after smoking and 16% of annual lung cancer deaths are attributable to residential radon exposure in Canada.The National Radon Program has a research focus aimed at investigating early predictors from residential radon exposure This HC REB approved project will aim to fulfill the research objectives by launching a pilot study with the CARTaGENE and Atlantic PATH cohorts which will generate new knowledge about the biological signatures for radon exposure and lead to further expansion into a full scale study involving other cohorts within the CPTP in subsequent years.

   We have included participants from the CARTaGENE that have a high probability of indoor radon levels above the national radon guideline of 200Bq/m3, which will strengthen the overall design for the pilot study. The biological samples, questionnaire data and physical measures that participants from the CARTaGENE cohort have shared are being accessed by many researchers to fulfill various research pursuits. Health Canada is seeking the opportunity to tap into this longitudinal study cohort as it is a valuable resource for conducting a well-designed study that will provide us new insights on the mechanistic responses to residential radon exposure. The information generated from the study will help contribute to the existing knowledge of mechanisms leading to radon induced lung cancer.

   5. Minimum Requirements

   Any interested supplier must demonstrate by way of a Statement of Capabilities that it meets the following minimum requirements:

1. Supplier must have custody of an active, longitudinal study cohort of at least 2000 participants, with the following characteristics:
   1. Cohort participants have given written consent for personal information and biological samples to be shared for research purposes, in accordance with the supplier’s data sharing and privacy policies;
   2. Cohort participants must be between the ages of 40 and 69 years;
   3. Cohort participants must live in an area with high radon potential “i.e., either more than 10% of indoor radon measurements collected in the area exceed 200 Bq/m3, or the area is characterized with surficial uranium concentrations greater than 1.5 eU.”
   4. Cohort participants must have already provided the supplier with information on their health status, lifestyle, and habits, and this information must be available to researchers, in accordance with the suppliers data sharing and privacy policies
   5. Cohort participants must have agreed in writing to be followed for at least 30 years
   6. Cohort participants must have agreed in writing to be re-contacted for follow-up and ancillary studies.
2. Supplier must have at least 10 years of experience in managing/hosting this longitudinal health study cohort.
3. Supplier must have the capacity to re-contact participants identified in item 1, recruit them for Health Canada’s study, and coordinate any additional data collection.
4. Supplier must maintain a bank of biological samples from the cohort participants identified in item 1 and/or be able to collect fresh samples from study participants, and must be able to grant access to these samples to Health Canada researchers, in accordance with the supplier’s data sharing and privacy policies.

   6. Reason for Non-Competitive Award

   Section 6 of the Government Contracts Regulations contains four exceptions that permit the contracting authority to set aside the requirement to solicit bids. For the proposed procurement, the following exception applies:

   (d) Only One Person or Firm is capable of performing the contract.

   7. Applicable trade Agreements and Justification for Limited Tendering or the Procurement Strategy for Aboriginal Business

This requirement is subject to the North American Free Trade Agreement (NAFTA), and the Canadian Free Trade Agreement (CFTA). The requirement is being directed to the proposed supplier as permitted under the following sections of the above trade agreements:

• Article 513 b) of the Canadian Free Trade Agreement (CFTA)
• Article 1016, 2(b) of the North American Free Trade Agreement (NAFTA

8. Ownership of Intellectual Property

Contractor will own the IP.

9. Period of the Proposed Contract

The contract period shall be from date of contract award until March 31^st, 2021.

10. Estimated Value of the Proposed Contract

The estimated value of the proposed contract is $118,763.00

11. Closing Date and Time

The Closing Date and Time for accepting Statements of Capabilities is April 9^th, 2019, 2PM EST.

12. Contact Person

All enquiries must be addressed by e-mail to:

Name: Cathy Jones
E-Mail: cathy.jones@canada.ca