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Natural History of HPV From Infection to Neoplasia in Adolescents and Young Women

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01366742
First received: June 2, 2011
Last updated: October 21, 2013
Last verified: October 2013
  Purpose

The natural history of HPV is most likely influenced by both innate and adaptive mucosal immunity. More specifically, we hypothesize that Toll like receptors (TLRs) 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 Thl like response through secretion of several cytokines and consequently, the induction of a successful cell mediated immune (CMI) response.


Condition Intervention
Human Papillomavirus
CIN 2
CIN 3
Other: No intervention; observational study

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Natural History of Human Papillomavirus From Infection to Neoplasia in Adolescents and Young Women - Effect of Tobacco on Cervical Neoplasia in Young Women

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • CIN 2/3 [ Time Frame: 1990 to current ] [ Designated as safety issue: Yes ]
    Observational study of women with HPV


Secondary Outcome Measures:
  • HPV persistence [ Time Frame: 1990 to present ] [ Designated as safety issue: Yes ]
    observational study of women with HPV


Biospecimen Retention:   Samples With DNA

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


Enrollment: 900
Study Start Date: December 1987
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Other: No intervention; observational study
No intervention; observational study
Other Name: No intervention; observational study

Detailed Description:

The natural history of HPV is most likely influenced by both innate and adaptive mucosal immunity. More specifically, we hypothesize that Toll like receptors (TLRs) 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 Thl like response through secretion of several cytokines and consequently, the induction of a successful cell mediated immune (CMI) response.

We propose to: 1) examine, in cervical cell samples, the association among TRL expression, TRL-associated cytokines that mediate innate immunity and clearance of incident HPV infection; 2) examine, in cervical cell samples, the association among TRL expression, TRL-associated cytokines that induce and mediate adaptive immunity and HPV clearance; and 3) examine the association among TLR induced Th-1 responses measured in cervical cell samples, HPV specific CMI responses detected in peripheral blood (PB) and HPV clearance. Adolescent and young women who were a) entered into the cohort during the initial 1990-1995 period and have continued to be followed and b) entered into the cohort during the last recruitment wave (2000-2005) will be asked to continue followup for an additional five years (2005-2010). These women will have been well characterized at the time of the initiation of this study with HPV at their entry visit and 4-month interval sampling for HPV DNA, cytology, bacterial vaginosis, colpophotographs (assessment of cervical maturation), C. trachomatis and N. gonorrhea testing, cervical cell cytokines by RT-PCR and PB CMI for HPV 16 positive women. Women will be continued to be characterized for the above at the same intervals through-out the follow-up. Measures of innate and adaptive immunity by RT PCR using cervical cells and by Luminex technology have been added to the same 4 month interval testing as HPV DNA, cytology and other cervical cytokines described. Women positive for HPV 16 will get additional blood for CMI using IFN-y EliSpot technique for detection of anti-E6 and E7 responses. We also examine the natural history of anal HPV in these women. We acknowledge that this design simplifies the pleiotropic nature of cytokines. However, we feel that this model reflects plausible mechanisms involved in HPV control and is feasible to test in our cohort. Information garnered from this type of study will be critical in developing vaccine strategies and therapies as well as illuminating immune responses developed in the mucosal epithelium.

  Eligibility

Ages Eligible for Study:   13 Years to 22 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Community

Criteria

Inclusion:

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

Exclusion:

  • Planning on moving in 3 years
  • Prior history of treatment for CIN
  • Immunocompromised (ie transplant patient, HIV)
  • Pregnant
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01366742

Locations
United States, California
SFSU Student Health Center
San Francisco, California, United States, 94132
HPV Study - San Leandro Office
San Leandro, California, United States, 94577
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Anna-Barbara Moscicki, MD University of California, San Francisco
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01366742     History of Changes
Other Study ID Numbers: 11-05580, R37CA051323
Study First Received: June 2, 2011
Last Updated: October 21, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on November 20, 2014