Laboratory Procedure Development and ValidationNCT01236027
Specimen Collection Study for Development and Validation of Laboratory Procedures
An observational study of Laboratory Procedure Development and Validation, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Laboratory Procedure Development and Validation
- How many people
- 245 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to 17 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: HIV-negative women
Who may be able to join
- 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.
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- Willing and able to provide written informed consent.
- Willing to provide contact information for receipt of laboratory results, as applicable.
- Reproductive-aged Group Inclusion Criteria:
- 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)
Who cannot join
- Control Group (post-menopausal) Exclusion Criteria:
- Use of hormone replacement therapy, including oral, vaginal and transdermal.
- Hysterectomy.
- An active urogenital infection within the past 14 days, including:
- Vaginal infections (symptomatic candidiasis, trichomonas vaginalis, and bacterial vaginosis).
- Cervical infections (Gonorrhea (GC), Chlamydia (CT) or mucopurulent cervicitis (MPC)).
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- Syphilis
- HSV/Genital Warts
- Urinary Tract Infection
- Recent exposure to a partner with GC, CT, trichomonas, syphilis, non-gonococcal urethritis, or HIV.
- Use of systemic or vaginal antibiotics or antifungals 14 days prior to genital sample collection.
- Participation in a microbicide or other vaginal product study within one month of genital sample collection.
- Use of a spermicide or spermicidally lubricated condom within one week prior to genital sample collection.
- Use of an internal vaginal device or product with the exception of tampons within one week of genital sample collection.
- 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:
- 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).
- Currently pregnant (or has been pregnant within the past 90 days) or breastfeeding
- Hysterectomy.
- Use of a diaphragm or NuvaRing for contraception or use of spermicide for primary contraception.
- An active urogenital infection within the past 14 days, including:
- Vaginal infections (symptomatic candidiasis, Trichomonas vaginalis and bacterial vaginosis).
- Cervical infections (Gonorrhea (GC), Chlamydia (CT) or Mucopurulent cervicitis (MPC).
- Syphilis
- HSV/Genital Warts
- Urinary Tract Infection
- Recent exposure to a partner with GC, CT, Trichomonas, syphilis, Non-gonococcal urethritis or HIV.
- Use of systemic or vaginal antibiotics or antifungals 14 days prior to genital sample collection.
- Participation in a microbicide and/or contraceptive study within one month of genital sample collection.
- Use of a spermicide or spermicidally lubricated condom within one week prior to genital sample collection.
- Use of an internal vaginal device or product with the exception of tampons within one week of genital sample collection.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Collection of Biological Specimens for Development and Validation of Laboratory Procedures to Support Future Clinical Research Studies
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.
- Being tested
- no intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
not applicable-no intervention
| Study group | Role | What they receive |
|---|---|---|
| HIV-negative women | HIV-negative women who agree to have specimens collected for validation of laboratory procedures Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of Laboratory Procedures
The primary aim of this study is to collect an adequate number of biological samples, as needed by investigators, to support development and validation of laboratory procedures necessary for upcoming topical microbicide and infectious disease research clinical trials.
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2010 (estimated)
- Study startNov 2010
- Primary completion17 Mar 2020
- Study completion17 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laboratory Procedure Development and ValidationStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 245 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katherine Bunge, University of Pittsburgh
- Investigators
- Sharon L Hillier, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01236027
- Sponsor's protocol ID
- PRO10080337
- Status last verified
- Nov 2020
- First submitted
- 4 Nov 2010
- Last updated
- 12 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection of Biological Specimens for Development and Validation of Laboratory Procedures to Support Future Clinical Research Studies
- ClinicalTrials.gov ID
- NCT01236027
- Acronym / sponsor ID
- PRO10080337
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 245 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- 17 Mar 2020 (actual)
- Study completion
- 17 Mar 2020 (actual)
- First posted
- 8 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIV-negative women | – | Other: no interventionHIV-negative women who agree to have specimens collected for validation of laboratory procedures |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- HIV-negative women
Key inclusion criteria (16 listed)
- 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.
Key exclusion criteria (32 listed)
- Use of hormone replacement therapy, including oral, vaginal and transdermal.
- Hysterectomy.
- An active urogenital infection within the past 14 days, including:
- Use of systemic or vaginal antibiotics or antifungals 14 days prior to genital sample collection.
- Participation in a microbicide or other vaginal product study within one month of genital sample collection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionnot applicable-no intervention | Other | HIV-negative women |
Primary outcome
Validation of Laboratory Procedures
Time frame: up to 5 years
The primary aim of this study is to collect an adequate number of biological samples, as needed by investigators, to support development and validation of laboratory procedures necessary for upcoming topical microbicide and infectious disease research clinical trials.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sharon L Hillier, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Laboratory Procedure Development and Validation, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation of Laboratory Procedures (time frame: up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2020.