Clinical trial NCT01236027: Specimen Collection Study for Development and Validation of Laboratory Procedures
Official title: Collection of Biological Specimens for Development and Validation of Laboratory Procedures to Support Future Clinical Research Studies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Laboratory Procedure Development and Validation
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2010-11-07
Enrollment: 245
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV-negative women

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 transport) to support future infectious disease clinical studies. In this research study, the investigators will collect blood samples, vaginal swabs, cervical swabs, mucus/vaginal discharge, cervicovaginal lavages, vaginal and cervical biopsies, as necessary, to use in the development of laboratory processes. The investigators will obtain the sample(s) from healthy HIV negative women. Samples will be collected and sent to Magee-Womens Research Institute as laboratory specimens are needed.


Eligibility criteria: Inclusion Criteria:

Control Group (post-menopausal) Inclusion:

1. Females, age greater than 50 years
2. Non-pregnant
3. Post-menopausal defined as no menses or vaginal bleeding for at least 1 year
4. Agree to have HIV testing or have documentation of a negative HIV test result within the past 6 months.
5. 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.
6. Willing and able to provide written informed consent.
7. Willing to provide contact information for receipt of laboratory results, as applicable.

Reproductive-aged Group Inclusion Criteria:

1. Females, 18-45 years of age
2. Non-pregnant
3. Agree to have HIV testing or have documentation of a negative HIV test result within the past 6 months.
4. Free from participant reports and clinician observed abnormal vaginal discharge or other current vaginal symptoms on the day of genital sample collection.
5. Willing and able to provide written informed consent.
6. Willing to provide contact information for receipt of laboratory results, as applicable.
7. Participant meets requirements of specific laboratory study needs (e.g. birth control method and length of use)

Exclusion Criteria:

Control Group (post-menopausal) Exclusion Criteria:

1. Use of hormone replacement therapy, including oral, vaginal and transdermal.
2. Hysterectomy.
3. An active urogenital infection within the past 14 days, including:

   1. Vaginal infections (symptomatic candidiasis, trichomonas vaginalis, and bacterial vaginosis).
   2. Cervical infections (Gonorrhea (GC), Chlamydia (CT) or mucopurulent cervicitis (MPC)).
   3. Syphilis
   4. HSV/Genital Warts
   5. Urinary Tract Infection
   6. Recent exposure to a partner with GC, CT, trichomonas, syphilis, non-gonococcal urethritis, or HIV.
4. Use of systemic or vaginal antibiotics or antifungals 14 days prior to genital sample collection.
5. Participation in a microbicide or other vaginal product study within one month of genital sample collection.
6. Use of a spermicide or spermicidally lubricated condom within one week prior to genital sample collection.
7. Use of an internal vaginal device or product with the exception of tampons within one week of genital sample collection.
8. Any other condition in the opinion of the site investigator would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of study outcome data or otherwise interfere with achieving study objectives.

Reproductive-aged Group Exclusion Criteria:

1. Menopausal (including natural menopause defined as lack of menses for 12 consecutive months, in the absence of pregnancy, and surgical menopause defined as a woman who has had both ovaries removed).
2. Currently pregnant (or has been pregnant within the past 90 days) or breastfeeding
3. Hysterectomy.
4. Use of a diaphragm or NuvaRing for contraception or use of spermicide for primary contraception.
5. An active urogenital infection within the past 14 days, including:

   1. Vaginal infections (symptomatic candidiasis, Trichomonas vaginalis and bacterial vaginosis).
   2. Cervical infections (Gonorrhea (GC), Chlamydia (CT) or Mucopurulent cervicitis (MPC).
   3. Syphilis
   4. HSV/Genital Warts
   5. Urinary Tract Infection
   6. Recent exposure to a partner with GC, CT, Trichomonas, syphilis, Non-gonococcal urethritis or HIV.
6. Use of systemic or vaginal antibiotics or antifungals 14 days prior to genital sample collection.
7. Participation in a microbicide and/or contraceptive study within one month of genital sample collection.
8. Use of a spermicide or spermicidally lubricated condom within one week prior to genital sample collection.
9. Use of an internal vaginal device or product with the exception of tampons within one week of genital sample collection.
10. Any other condition in the opinion of the site investigator would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of study outcome data or otherwise interfere with achieving the study objectives.

Primary outcomes:
measure: Validation of Laboratory Procedures
timeFrame: up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Magee-Womens Hospital of UPMC
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Sharon L Hillier, PhD
role: PRINCIPAL_INVESTIGATOR
References: