Ignite Creation Date:
2024-05-06 @ 3:56 AM
Last Modification Date:
2024-10-26 @ 11:41 AM
Study NCT ID:
NCT02416154
Status:
COMPLETED
Last Update Posted:
2021-12-27
First Post:
2015-04-09
Brief Title:
Expression of IFN-epsilon in the Female Reproductive Tract
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
IFN-epsilon and Hormonal Contraceptive Modulation of the Risk of HIV Acquisition Part 1 Expression in the Female Reproductive Tract
Status:
COMPLETED
Status Verified Date:
2021-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Epsilon
Brief Summary:
The proposed study aims to determine the expression of Interferon-ε IFNε in the female genital tract which has never been mapped before in humans High expression in other mammalian female reproductive tract FRT has been suggested to be important in anti-sexually transmitted infection STIHIV immunity and its expression decreases with progestogen treatment Future studies are planned to understand if hormonal contraceptives affect the presence of interferon in the healthy female genital tract potentially changing the risk of for STI and HIV
Detailed Description:
Objectives
1 To optimize measurement protocols for IFNε and related biomarkers in samples from the female reproductive tract
2 To quantify and characterize IFNε expression in the upper and lower genital tract and blood in normally cycling women during the follicular and luteal phases of the menstrual cycle
Study design This is a single site parallel cross-sectional study
Specific Aims
The aim of this study is to determine which IFNε -related assays can be performed on different types of FRT samples The possible IFNε-related assays are
IFNε messenger ribonucleic acid mRNA levels by quantitative reverse transcriptase polymerase chain reaction qRT PCR requiring frozen tissue processed for RNA
IFN Regulated Gene expression by qRT PCR microarray or targeted gene set using Fluidigm platform frozen tissue
PR and ER gene expression as above
IFNε tissue protein levels by immunoassay and progesterone and estrogen receptors PRER by Western blotting frozen tissue
IFNε and Neopterin a well characterized compound whose production can be stimulated by IFNs and whose specificity in this setting needs validation or other IFNε-biomarkers by immunoassay in cervicovaginal lavage CVL fluids
Immunohistochemistry of IFNε PRER other eg cells cytokines fixed tissue
Studies of FRT samples from wild type and IFNε-- mice would be used to first validate Neopterin as a biomarker of IFNε activity in the FRT and microarray analyses may reveal other secreted proteins that may be used as biomarkers of IFNε activity
1 To optimize measurement protocols for IFNε and related biomarkers in samples from the female reproductive tract
2 To quantify and characterize IFNε expression in the upper and lower genital tract and blood in normally cycling women during the follicular and luteal phases of the menstrual cycle
Study design This is a single site parallel cross-sectional study
Specific Aims
The aim of this study is to determine which IFNε -related assays can be performed on different types of FRT samples The possible IFNε-related assays are
IFNε messenger ribonucleic acid mRNA levels by quantitative reverse transcriptase polymerase chain reaction qRT PCR requiring frozen tissue processed for RNA
IFN Regulated Gene expression by qRT PCR microarray or targeted gene set using Fluidigm platform frozen tissue
PR and ER gene expression as above
IFNε tissue protein levels by immunoassay and progesterone and estrogen receptors PRER by Western blotting frozen tissue
IFNε and Neopterin a well characterized compound whose production can be stimulated by IFNs and whose specificity in this setting needs validation or other IFNε-biomarkers by immunoassay in cervicovaginal lavage CVL fluids
Immunohistochemistry of IFNε PRER other eg cells cytokines fixed tissue
Studies of FRT samples from wild type and IFNε-- mice would be used to first validate Neopterin as a biomarker of IFNε activity in the FRT and microarray analyses may reveal other secreted proteins that may be used as biomarkers of IFNε activity
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None