NCT01366742

Brief Summary

The natural history of human papillomavirus (HPV) is most likely influenced by both innate and adaptive mucosal immunity. More specifically, we hypothesize that Toll like receptors (TLR) play an important role in cervical innate immunity to HPV through secretions of proinflammatory, chemotactic and anti-viral cytokines. Up-regulated TLR expression will also result in activation of dendritic cells and T cells that in turn will promote a T helper (Th) l like response through secretion of several cytokines and consequently, the induction of a successful cell mediated immune (CMI) response.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
900

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 1987

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 1987

Completed
23.5 years until next milestone

First Submitted

Initial submission to the registry

June 2, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 6, 2011

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

May 17, 2016

Status Verified

May 1, 2016

Enrollment Period

28.4 years

First QC Date

June 2, 2011

Last Update Submit

May 13, 2016

Conditions

Human PapillomavirusCIN 2CIN 3

Outcome Measures

Primary Outcomes (1)

  • Cervical Intraepithelial neoplasia (CIN) 2/3

    Observational study of women with HPV

    1990 to current

Secondary Outcomes (1)

  • HPV persistence

    1990 to present

Study Arms (1)

HPV Cohort

Sexually active young women aged 12 to 22 years of age without a previous history of CIN. Women are not eligible for entry if pregnant or known immunosuppression.

Eligibility Criteria

Age13 Years - 22 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Community

You may qualify if:

  • Age 12 to 22 years
  • Sexually active less than 6 years
  • Received one dose of the HPV vaccine

You may not qualify if:

  • Planning on moving in 3 years
  • Prior history of treatment for CIN
  • Immunocompromised (ie transplant patient, HIV)
  • Pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

SFSU Student Health Center

San Francisco, California, 94132, United States

Location

HPV Study - San Leandro Office

San Leandro, California, 94577, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Rbc, WBC vaginal lavages ,cytology,saliva ,anal samples

Study Officials

  • Anna-Barbara Moscicki, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2011

First Posted

June 6, 2011

Study Start

December 1, 1987

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

May 17, 2016

Record last verified: 2016-05

Locations

US(2)