Defense and Veterans Center for Integrative Pain Manageme... | NCT04004286

Studies
Defense and Veterans Center for Integrative Pain Management (DVCIPM) Pain Registry Biobank

NCT04004286

Sponsor

Defense and Veterans Center for Integrative Pain Management

Status

Recruiting

Last Update Posted

Jan 28, 2026Actual

Enrollment

300Estimated

Phase

Not provided

Conditions

Pain

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2019Actual

Primary Completion Date

Feb 2050Estimated

Completion Date

Feb 2050Estimated

First Submitted Date

Jun 13, 2019

First Submission Date that Met QC Criteria

Jul 1, 2019

First Posted Date

Jul 2, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 26, 2026

Last Update Posted Date

Jan 28, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This Pain Registry Biobank is a prospective cohort design study whereby data (PASTOR survey, blood and saliva specimens, clinical data) is collected from participants in a longitudinal fashion with continual enrollment.

Detailed Description

The Defense and Veterans Center for Integrative Pain Management (DVCIPM) established a clinical data registry and tissue biobank (pain registry/biobank) for the advancement of pain-related research. This Pain Registry Biobank will address the complexity of pain by utilizing the Pain Assessment Screening Tool & Outcomes Registry (PASTOR), a thorough biopsychosocial assessment that extends beyond a single-item pain rating scale. PASTOR is an assessment battery that includes several Patient Reported Outcomes Measurement Information System (PROMIS) scales developed by the National Institutes of Health (NIH) and other important scales that span physical, psychological, social, and behavioral aspects of pain and pain-related treatments. As a uniform assessment system, PASTOR also mitigates a significant challenge in pain-related research, the lack of standardized, cross-study outcomes. Additionally, the richness of PASTOR data matched with biological samples allows future researchers to address significant research gaps and enhance health care for service members, veterans, and civilians.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

300Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain Registry: PASTOR survey	a thorough biopsychosocial assessment computer adaptive screening tool that extends beyond a single-item pain rating scale. PASTOR is an assessment battery that includes several Patient Reported Outcomes Measurement Information System (PROMIS) scales developed by the National Institutes of Health (NIH) and other important scales that span physical, psychological, social, and behavioral aspects of pain and pain-related treatments.	Up to 30 years
Pain Registry: Blood specimens	43 ml of blood collected and processed for storage from EDTA, BDP 100, PAXgene RNA, and DNA blood collection tubes	Up to 30 years
Pain Registry: Saliva	up to 10ml of saliva, collected in 2ml cryovials.	Up to 30 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Eligibile for care within the Military Healthcare System
Able and willing to provide written consent

Exclusion Criteria:

Cannot understand English

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Male and female military health care beneficiaries age 18 years and older presenting for an appointment care at WRNMMC

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mary E McDuffie, RN,BSN	Contact	301/400/4242		mary.mcduffie.ctr@usuhs.edu

Overall Officials

Name	Affiliation	Role
Harold J Gelfand, MD	Defense and Veterans Center for Integrative Pain Management	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Naval Medical Center San Diego	Recruiting	San Diego	California	92134	United States

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
ICF	No	No	Yes	Informed Consent Form	Feb 1, 2020	Jun 25, 2020	ICF_000.pdf

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided