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. At Wave 1, all adults were asked to provide biospecimens (urine and blood). In each follow-up wave, two categories of people were asked to provide biospecimens: those who provided specimens at a previous wave (e.g. the Wave 1 Biomarker Core, see BRUF User Guide for more detail), and those who turned 18 and completed their first adult interview at the given wave (aged-up adults). For those who provided a specimen at a previous wave, only urine was requested at subsequent waves. For aged-up adults, urine and blood were requested.

The PATH Study Biospecimen Access Program provides the research community with access to urine, serum, plasma and genomic DNA (gDNA) 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 and blood collected from adults in Waves 1 and 2 (including serial samples from the same participant over time), 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 Waves 1 and 2
Biospecimens Wave 1 Wave 2
Urine 19,237 11,961
Serum 13,834 805
Plasma 13,841 842
gDNA 6,597 N/A

Questionnaire data on behaviors, attitudes, and health conditions for PATH Study respondents 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 data 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 RUF and 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. Currently, biomarker data from urine, serum, and plasma are available (no genetic data has been analyzed as part of the PATH Study). 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 RUF Data1
Urine
(19,237)
Serum, Plasma
(13,841)
gDNA
(6,597)
Urine
(10,790)
Serum, Plasma
(6,992)
gDNA
(6,566)
Poly2 Exclusive3 Poly Exclusive Poly Exclusive Poly Exclusive Poly Exclusive Poly Exclusive
Cigarette 3,904 4,337 2,796 3,269 2,244 1,791 3,719 2,772 2,373 1,906 2,243 1,791
E-Cigarette 2,056 151 1,483 210 1,214 155 1,964 119 1,267 171 1,213 155
Traditional Cigar 1,342 277 922 187 730 102 1,248 189 785 109 730 102
Cigarillo 1,943 169 1,332 118 1,066 80 1,808 138 1,137 87 1,066 80
Filtered Cigar 877 21 634 18 513 14 835 18 543 13 513 14
Pipe Tobacco 438 25 311 16 252 14 416 23 270 13 252 14
Hookah 1,492 516 988 305 779 192 1,395 397 833 207 779 192
Smokeless Tobacco 753 448 492 283 417 223 730 435 443 249 417 223
Snus Pouches 314 20 230 13 182 9 298 17 197 10 182 9
Nonusers — never users 2,263 1,579 906 1,490 959 906
Nonusers — former users 5,605 4,040 309 470 300 280


Table 3 displays the numbers of Wave 2 adults in each tobacco product user group with available biospecimens and the subsets of these participants with available biomarker data.

Table 3. Wave 2 Adults with Biospecimens and Biomarker Data
Tobacco product Participants with Biospecimens Participants with Biomarker Data1
Urine
(11,961)
Serum, Plasma
(842)
Urine
(8,426)
Poly2 Exclusive3 Poly Exclusive Poly Exclusive
Cigarette 2,647 3,581 104 40 2,194 2,634
E-Cigarette 1,821 396 100 42 1,457 303
Traditional Cigar 711 168 38 0 591 113
Cigarillo 861 56 49 5* 707 38
Filtered Cigar 510 15 19 424 11
Pipe Tobacco 243 15 11 207 12
Hookah 844 172 92 28 632 104
Smokeless Tobacco 528 330 31 5 447 312
Snus Pouches 183 6 13 0 152 4
Nonusers — never users 2,091 325 1,140
Nonusers — former users 1,740 203 1,060


Table 4 displays the number of adults in each tobacco product user group with serial urine samples from Waves 1 and 2.

Table 4. Wave 1 Tobacco Product Use for Adults with Serial Urine Samples from Waves 1 and 2
Tobacco product Participants with Biomarker Data1
Urine
(7,902)
Poly2 Exclusive3
Cigarette 2,108 2,480
E-Cigarette 1,392 216
Traditional Cigar 578 112
Cigarillo 687 38
Filtered Cigar 407 9
Pipe Tobacco 204 12
Hookah 616 102
Smokeless Tobacco 439 308
Snus Pouches 151 4
Nonusers — never users 1,003
Nonusers — former users 1,018

Note: 1Participants with biomarker data are from the Wave 1 Biomarker Core. The Wave 1 Biomarker Core is a subsample of those who provided specimens and was selected to represent a diverse mix of tobacco users and non-users. See section 3.1.1 in the Biomarker Restricted Use Files user guide for more details. 2Poly users are participants who use more than one type of tobacco product. 3Exclusive users are participants who use only one type of tobacco product. *Due to small sample sizes, this cell represents any cigar product use.

The information in these tables 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

Last updated: 9/16/2019