NCT01089153

Completed

Obtaining and Storing Human Blood, Urine, and Fecal Samples ...

Southwest Regional Wound Care Center Source

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Other study identifiers

Sponsor study identifier

56-RW-015

Study Type

observational

Actual enrollment (reported)

35

Locations

0 countries

Sites

N/A

Timeline

Study Start

February 2010

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

December 2010

Actual (reported)

Study Completion

December 2010

Actual (reported)

Brief Summary

Current spirochaete infection identification and diagnostic strategies have important limitations. Recent development may allow for an improvement in diagnostic, screening and survey capabilities. The goal of this study is to evaluate blood, urine and fecal samples from a variety of sources and generate information on the occurrence and epidemiology of spirochetes in the general and at risk populations.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 35 participants
Study completion date: December 2010
Actual (reported)
Listed locations: 0 countries · 0 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
February 2010
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
March 16, 2010
Actual (reported)
First Posted
March 18, 2010
Actual (reported)
Primary Completion
December 2010
Actual (reported)
Study Completion
December 2010
Actual (reported)

Last Updated: September 7, 2011
Status Verified: September 2011
Last Update Submitted: September 6, 2011

Conditions

The Samples Will be Studied in Order to Attempt to Better Understand the Occurrence of Blood, Feces and Urine Borne Spirochaetes

Keywords

human blood, urine and fecal samples

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Blood, feces and urine samples may be collected from subjects with known or suspected spirochetal disease or from subjects not suspected to be infected with spirochetes

You may qualify if:

The subject must be able to be fully consented to the study.
The subject must be 18 years of age or older.
The subject must be mentally competent as determined by the Investigator.

You may not qualify if:

The subject must not be currently incarcerated or pregnant.

Sponsors & Collaborators

Southwest Regional Wound Care Center
Otherlead

Biospecimen

Retention: SAMPLES WITH DNA

human blood, urine and fecal samples

Study Officials

Randall Wolcott, MD
Southwest Regional Wound Care Center
PRINCIPAL INVESTIGATOR

Enrollment

35 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: CASE ONLY
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Prinicipal Investigator

Study Record Dates

First Submitted

March 16, 2010

First Posted

March 18, 2010

Study Start

February 2010

Date type not reported

This date has not been verified as actual or estimated.

The subject must not weigh less than 110lbs.

If the subject will be contributing more that 60 ml of blood during an 8 (eight) week period, then the subject must not have donated red blood cells within the last 8 (eight) weeks.

If the Subject's health would be compromised by contributing up to 30ml of peripheral blood.

If in the opinion of the Investigator, the subject has any clinically significant medical diagnosis/conditions which would prevent participation.

Contact the study team to confirm eligibility.

Primary Completion

December 2010

Actual (reported)

Study Completion

December 2010

Actual (reported)

Last Updated

September 7, 2011

Record last verified: 2011-09

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT01089153
Data provider: ClinicalTrials.gov
Source updated: 2011-09-07
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:34:14 UTC

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Biospecimen

Study Officials

Enrollment

Study Design

Study Record Dates

Source record