PATH Study Biospecimen Access Program Overview

On April 24, 2025, NIH requested that the following language be added to this website: “**UPDATE TO THE PATH STUDY BIOSPECIMEN ACCESS PROGRAM (BAP): As of 4/24/2025, the BAP will be on hiatus and will not accept any new concept statements or applications. We appreciate your interest in the BAP and will provide any updates here.**”

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 PATH Study Biospecimen Access Program provides the research community with access to urine, serum, plasma, buffy coat, red blood cells, PAXgene RNA tubes (PAXgene), genomic DNA (gDNA), and buccal cells collected from PATH Study participants. Investigators proposing meritorious and feasible studies, including exploratory or pilot studies, consistent with  “How to Apply for Biospecimens”.

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 adults (18 years and older) who currently use a wide array of tobacco products, people who formally used tobacco products, and people who do not use tobacco. At Wave 1, all adults were asked to provide biospecimens (urine, blood, and buccal cells). In Waves 2-5 and 7, urine was collected from adult participants who provided urine in a previous wave as well as a subset of additional adult participants. In Waves 2-5, urine and blood was collected from youth who provided urine in a previous wave as well as a subset of additional youth participants. No biospecimens were collected from any participants during Wave 6 because of the COVID 19 pandemic.

Urine and blood samples from participants selected for a Biomarker Core (i.e., Wave 1 Biomarker Core, Wave 4 Biomarker Core) were sent for laboratory analysis and biomarker data is available for those participants. See chapter 1 in the Biomarker Restricted Use File (BRUF) User Guide for background of each biomarker core’s selection and analysis.

The PATH Study also provides investigators with access to other resources including questionnaire and biomarker data, flagging those with available biospecimens. 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 participants in Waves 1 through 7 (including serial urine samples from the same participant over time), DNA and buccal cells collected from adults in Wave 1 (see Tables 1-3 below). There are no serial blood specimens at this time. More information on PATH Study biospecimens, including the collection, processing and storage protocols, can be found on the PATH Study BRUF page and in the BRUF User Guide.

Table 1. Number of Participants with Cross-Sectional Biospecimens Available in Waves 1 through 7
Biospecimens
Urine
Serum
Plasma
Buffy Coat
Red Blood Cells
PAXgene
gDNA
Buccal Cells

Adults Wave 1 Total

19,511

13,829

13,910

12,021

13,346

13,643

6,597

11,179

Adults Wave 1 with Biomarker Data1

12,497

7,983

7,880

6,623

7,565

7,649

6,571

Adults Wave 2 Total

11,958

807

854

800

828

842

N/A

N/A

Adults Wave 2 with Biomarker Data

8,424

N/A

N/A

N/A

N/A

N/A

Adults Wave 3 Total

13,067

781

799

759

786

789

N/A

N/A

Adults Wave 3 with Biomarker Data

8,116

N/A

N/A

N/A

N/A

N/A

Adults Wave 4 Total

19,188

3,147

3,495

3,351

3,377

3,368

N/A

N/A

Adults Wave 4 with Biomarker Data

7,868

N/A

N/A

N/A

N/A

N/A

Youth Wave 4 Total

11,720

N/A

N/A

N/A

N/A

N/A

N/A

N/A

Youth Wave 4 with Biomarker Data

3,332

Adults Wave 5 Total

11,761

1,954

1,990

1,904

1,942

1,937

N/A

N/A

Adults Wave 5 with Biomarker Data2

9,021

N/A

N/A

N/A

N/A

N/A

N/A

N/A

Youth Wave 5 Total

10,240

N/A

N/A

N/A

N/A

N/A

N/A

N/A

Youth Wave 5 with Biomarker Data

2,061

Adults Wave 7 Total

11,119

N/A

N/A

N/A

N/A

N/A

N/A

N/A

Adults Wave 7 with Biomarker Data

7,016

Youth Wave 7 Total

467

N/A

N/A

N/A

N/A

N/A

N/A

N/A

Youth Wave 5 with Biomarker Data

467

Table 2. Wave 1 Biomarker Core Participants with Serial Urine Available
Waves
Number

Waves 1 and 2

8,821

Waves 1, 2, and 33

6,712

Waves 1, 2, 3, and 43

5,616

Waves 1, 2, 3, 4, and 53

4,858

Waves 1, 2, 3, 4, 5 and 73

3,180

Table 3. Wave 4 Biomarker Core Participants with Serial Urine Available
Waves
Number

Waves 4 and 5

2,733

Waves 4, 5 and 73

1,162

Notes

Table 1-3 Notes: 1Urine samples have urine biomarker data (i.e., urinary nicotine metabolites, tobacco specific nitrosamines, volatile organic compound metabolites, metals, etc.) and blood component samples have blood biomarker data (i.e., serum cotinine, hsCRP, IL-6, sICAM, and fibrinogen). 2This row combines participants with data from any Biomarker Core. 3Serial samples are also available for subsets of these waves, (i.e., Waves 2-3, Waves 3-5, etc.). Serial specimens from the Wave 4 Biomarker Core could also be requested with serial specimens from the Wave 1 Biomarker Core. The information in these tables will be updated to reflect the most recent availability information as well as when data from additional waves become available.

Questionnaire data on tobacco use behaviors, attitudes, and health conditions for PATH Study respondents are available to link to specimens in public-use (PUF) and restricted-use (RUF) files. Tobacco use data on cigarette, traditional cigar, cigarillos, filtered cigars, hookah, pipe (adults only), smokeless tobacco, and snus are collected from respondents. Measures of current use (every day or some days), past-30 day use, past-3 day, and daily use are all available. 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 the Biomarker Cores are available in the BRUF. Participants were sampled to include those who do not use tobacco and those who use a diverse mix of tobacco products (based on self-reported data available in the questionnaire RUF and PUF). Two separate subsamples were selected, first adults at Wave 1, and then youth at Wave 4. These subsamples constitute the Wave 1 Biomarker Core and the Wave 4 Biomarker Core, and urine is requested from them at each primary wave, except Wave 6. Table 1 indicates the subsets of participants with available biospecimens and biomarker data at each wave cross-sectionally (this combines the Wave 1 and Wave 4 Biomarker Cores).

Tables 2-3 show the number of serial urine specimens available for the Wave 1 Biomarker Core and Wave 4 Biomarker Core, respectively. Currently, only biomarker data from urine (Waves 1-7), serum (Wave 1 only), and plasma (Wave 1 only) are available. No genetic data have been analyzed as part of the PATH Study. The BRUF also contains data from Nicotine Exposure Questions (NEQs) in Urine or Blood collection data files that correspond to recent tobacco or medication exposure prior to specimen collection. Biomarker Restricted-Use File: Initial Release Information provides a rough timeline for when biomarker data is expected to be released and PATH Study Biomarkers by Wave provides a complete list of biomarkers measured in each wave. Investigators who wish to access biomarker RUF data must complete an online application, which may be accessed on the PATH Study Biomarker RUF page.

Master Linkage File (available in both RUF and PUF) contains indicator variables for respondents who have at least one available aliquot for the Biospecimen Access Program. These variables, when linked with the questionnaire and/or biomarker data, allow researchers to explore specimen availability for their subgroups of interest while completing their concept statement. These variables are available for Wave 1 through Wave 7 (e.g., WAVE1_BAP_URINE; WAVE1_BAP_PLASMA; etc.). See FAQ page for more details.

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: 02/26/2024