Multi-center Evaluation of the VERSANT® CT/GC DNA 1.0 Assay (kPCR)in Detecting C. Trachomatis and N. Gonorrhoeae
The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by Siemens Healthcare Diagnostics Inc.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Siemens Healthcare Diagnostics Inc
Information provided by:
Siemens Healthcare Diagnostics Inc
ClinicalTrials.gov Identifier:
NCT01167777
First received: July 21, 2010
Last updated: August 28, 2010
Last verified: August 2010
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Purpose
Multicenter clinical study to test a new qualitative in vitro nucleic acid amplification assay based on kPCR technology. The assay is intended for the diagnosis of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC).
| Condition |
|---|
|
Chlamydia Gonorrhea |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Multi-center Evaluation of the VERSANT® CT/GC DNA 1.0 Assay (kPCR)in Detecting C. Trachomatis and N. Gonorrhoeae |
Resource links provided by NLM:
Further study details as provided by Siemens Healthcare Diagnostics Inc:
| Estimated Enrollment: | 3000 |
| Study Start Date: | August 2010 |
| Groups/Cohorts |
|---|
|
male/female
Symtomatic and asymptomatic males and females attending STD, family planning, public health and women's health clinics, or other applicable centers, who are being screened for CT or GC.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Symptomatic and asymptomatic male and female patients attending STD, family planning, public health and women's health clinics, or other applicable centers, who are being screened for CT or GC
Criteria
Inclusion Criteria:
- Subject is 18 years of age or older.
- Subject signed an IRB approved informed consent form.
- Subject is able to follow verbal and written instructions.
Exclusion Criteria:
- Subject has been on antibiotic therapy within 21 days prior to study enrollment.
- Subject urinated within one hour prior to sample collection.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01167777
Please refer to this study by its ClinicalTrials.gov identifier: NCT01167777
Contacts
| Contact: VALERIE NGUYEN, MS | 510.982.4123 | valerie.nguyen@siemens.com | |
| Contact: NORMAND DESPRES, PhD | 914.524.2680 | normand.despres@siemens.com |
Locations
| United States, Alabama | |
| University of Alabama At Birmingham | Not yet recruiting |
| Birmingham, Alabama, United States, 35294 | |
| Contact: CONNIE LENDERMAN, MBA, MT(ASCP) clende@uab.edu | |
| Principal Investigator: EDWARD W HOOK III, MD | |
| United States, California | |
| Los Angeles County Department of Public Health | Not yet recruiting |
| Los Angeles, California, United States, 90007 | |
| Contact: APURVA UNIYAL auniyal@ph.lacounty.gov | |
| Principal Investigator: PETER KERNDT, MD, MPH | |
| San Francisco Dept of Public Health | Not yet recruiting |
| San Francisco, California, United States, 94103 | |
| Contact: Hanna Hjord, MPH Hanna.Hjord@sfdph.org | |
| Principal Investigator: SUSAN PHILIP, MD, MPH | |
| San Joaquin County Public Health Services | Recruiting |
| Stockton, California, United States, 95205 | |
| Contact: DIANE SCHULTZ dschultz@sjcphs.org | |
| Principal Investigator: STEPHEN A WILLIS | |
| United States, Indiana | |
| Indiana University | Not yet recruiting |
| Indianapolis, Indiana, United States, 46202 | |
| Contact: DEANNA FULLER, MS, MT(ASCP) dfuller@iupui.edu | |
| Principal Investigator: THOMAS E DAVIS, MD PhD | |
| United States, Maryland | |
| Johns Hopkins University | Not yet recruiting |
| Baltimore, Maryland, United States, 21205 | |
| Contact: MATHILDA BARNES mbarnes2@jhmi.edu | |
| Principal Investigator: CHARLOTTE GAYDOS, DrPH | |
| United States, Minnesota | |
| Hennepin County Medical Center | Not yet recruiting |
| Minneapolis, Minnesota, United States, 55415 | |
| Contact: KEVAN HANSEN kevan.hanson@hcmed.org | |
| Principal Investigator: GLEN HANSEN, PhD | |
Sponsors and Collaborators
Siemens Healthcare Diagnostics Inc
More Information
No publications provided
| Responsible Party: | Valerie Nguyen, Senior Manager, Clinical Affairs, Siemens Healthcare Diagnostics Inc. |
| ClinicalTrials.gov Identifier: | NCT01167777 History of Changes |
| Other Study ID Numbers: | MCSA-VkPCRCTGC-200810-PRO |
| Study First Received: | July 21, 2010 |
| Last Updated: | August 28, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Siemens Healthcare Diagnostics Inc:
|
CT GC NG chlamydia gonorrhoeae |
Additional relevant MeSH terms:
|
Gonorrhea Bacterial Infections Genital Diseases, Female Genital Diseases, Male Gram-Negative Bacterial Infections |
Infection Neisseriaceae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Bacterial |
ClinicalTrials.gov processed this record on March 03, 2015