Status:
COMPLETED
Specimen Collection Study for Development and Validation of Laboratory Procedures
Lead Sponsor:
University of Pittsburgh
Conditions:
Laboratory Procedure Development and Validation
Eligibility:
FEMALE
18+ years
Brief Summary
Biologic samples are necessary for development and validation of laboratory procedures (e.g. novel biological and analytical assays, explant tissue models, validation of specimen collection and transp...
Eligibility Criteria
Inclusion
- Control Group (post-menopausal) Inclusion:
- Females, age greater than 50 years
- Non-pregnant
- Post-menopausal defined as no menses or vaginal bleeding for at least 1 year
- Agree to have HIV testing or have documentation of a negative HIV test result within the past 6 months.
- Free from participant report and clinician observed abnormal discharge or other vaginal symptoms (with the exception of vaginal dryness) on the day of genital sample collection.
- Willing and able to provide written informed consent.
- Willing to provide contact information for receipt of laboratory results, as applicable.
- Reproductive-aged Group
- Females, 18-45 years of age
- Non-pregnant
- Agree to have HIV testing or have documentation of a negative HIV test result within the past 6 months.
- Free from participant reports and clinician observed abnormal vaginal discharge or other current vaginal symptoms on the day of genital sample collection.
- Willing and able to provide written informed consent.
- Willing to provide contact information for receipt of laboratory results, as applicable.
- Participant meets requirements of specific laboratory study needs (e.g. birth control method and length of use)
Exclusion
- Control Group (post-menopausal)
Key Trial Info
Start Date :
November 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 17 2020
Estimated Enrollment :
245 Patients enrolled
Trial Details
Trial ID
NCT01236027
Start Date
November 1 2010
End Date
March 17 2020
Last Update
November 12 2020
Active Locations (1)
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1
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, United States, 15213