INTRODUCTION

WHAT IS THE PATH STUDY BIOSPECIMEN ACCESS PROGRAM?

The Population Assessment of Tobacco and Health (PATH) Study is an ongoing national cohort study designed to generate longitudinal epidemiologic data on tobacco use behaviors including patterns of use, attitudes, beliefs, exposures, and related health conditions. The Wave 1 (baseline) cohort is a household-based, nationally representative sample of approximately 46,000 participants. These include youth (12 to 17 years) and adult (18 years and older) current users of a wide array of tobacco products, former tobacco product users, and nonusers. Both biospecimens (urine and blood) and questionnaire data are collected from PATH Study participants in four annual waves. In addition, biospecimens from subsets of participants in each wave are analyzed for biomarkers of tobacco exposure and potential harm.

The PATH Study Biospecimen Access Program provides the research community with access to urine, serum, plasma and DNA collected from PATH Study participants. Investigators proposing meritorious and feasible studies consistent with PATH Study objectives and/or research priorities for tobacco regulatory science will be given highest priority for access to these biospecimens. Proposals addressing other objectives that advance the knowledge of tobacco use and/or tobacco-related health outcomes will also be considered. Investigators wishing access to these biospecimens must follow the procedures under "How to Apply for Biospecimens".

The PATH Study also provides investigators with access to other resources including questionnaire and biomarker data. Investigators who wish to access these data for use with PATH Study biospecimens must do so through a separate application process, as indicated under "Available Resources" below. If approved for access to both PATH Study biospecimens and associated questionnaire/biomarker data, investigators will be able to merge the results of their laboratory analysis of PATH Study biospecimens to associated questionnaire/biomarker data.

Additional information on the PATH Study Biospecimen Access Program is provided in the PATH Study Biospecimen Access - Policies and Procedures for Investigators

AVAILABLE RESOURCES

Biospecimens that are currently available to researchers through the PATH Study Biospecimen Access Program include urine, serum, plasma, and DNA collected from adults in Wave 1 (see Table 1). More information on PATH Study biospecimens, including the collection, processing and storage protocols, can be found on the PATH Study Biomarker Restricted-Use Files (RUF) page and in the PATH Study Biomarker RUF User Guide.

Table 1. Available Biospecimens from Adults in Wave 1
Biospecimens Wave 1
Urine 21,801
Serum 14,520
Plasma 14,520
DNA 6,597

Questionnaire data on behaviors, attitudes, and health conditions for ~32,000 adults in Wave 1 are available in public-use (PUF) and restricted-use (RUF) files. Investigators may download PUF data directly from the PATH Study PUF page. Investigators who wish to access RUF data must complete an on-line application, which may be accessed on the PATH Study RUF page.

Biomarker results for subsamples of PATH Study participants are available in the biomarker RUF. Participants were sampled to include tobacco product nonusers and a diverse mix of tobacco product users (based on self-reported data available in the questionnaire PUF). Table 2 displays the numbers of Wave 1 adults in each tobacco product user group with available biospecimens and the subsets of these participants with available biomarker data. Investigators who wish to access biomarker RUF data must complete an on-line application, which may be accessed on the PATH Study Biomarker RUF page.

Table 2. Wave 1 Adults with Biospecimens and Biomarker Data
Tobacco product Participants with Biospecimens Participants with Biomarker Data
Urine
(21,801)
Serum, Plasma
(14,520)
DNA
(6,597)
Urine
(11,522)
Serum, Plasma
(7,159)
DNA
(6,545)
Poly Exclusive Poly Exclusive Poly Exclusive Poly Exclusive Poly Exclusive Poly Exclusive
Cigarette 8,246 4,241 5,727 2,969 3,666 1,559 6,126 2,572 3,955 1,687 3,656 1,555
E-Cigarette 1,181 211 833 146 674 115 1,090 198 730 132 672 115
Traditional Cigar 645 74 421 52 328 39 597 68 362 41 327 38
Cigarillo 953 90 640 60 497 43 880 84 549 50 497 43
Filtered Cigar 437 14 296 12 237 10 399 13 255 9 236 9
Pipe Tobacco 228 19 154 12 129 10 220 17 136 10 128 10
Hookah 792 207 493 107 378 82 724 189 413 88 378 82
Smokeless Tobacco 1,129 452 725 286 567 214 1,058 418 636 248 565 213
Snus Pouches 199 13 147 7 113 6 181 13 122 7 112 6
Nonusers — never users 2,736 1,677 906 1,700 987 902
Nonusers — former users 6,181 4,196 304 473 301 275

Note: Poly users are participants who use more than one type of tobacco product. Exclusive users are participants who use only one type of tobacco product.


The information in Tables 1 and 2 will be updated as data from additional waves become available.

For additional information about PATH Study questionnaire and biomarker data, see:

Contact Us

For inquiries regarding the PATH Study biospecimen resource and procedures for access, contact the PATH Study team at PATHStudyBiospecimens@westat.com.

To link directly to the PATH Study Biospecimen Access Program page via shortened URL, use http://bit.ly/2wBFOtc