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Natural History of Human Papillomavirus From Infection to Neoplasia in Adolescents and Young Women - Effect of Tobacco on Cervical Neoplasia in Young Women


N/A
13 Years
22 Years
Open (Enrolling)
Female
Human Papillomavirus, CIN 2, CIN 3

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Trial Information

Natural History of Human Papillomavirus From Infection to Neoplasia in Adolescents and Young Women - Effect of Tobacco on Cervical Neoplasia in Young Women


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. gonorrohea 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.

Inclusion 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

- Immunocomprimised (ie transplant patient, HIV)

- Pregnant

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Principal Investigator

Anna-Barbara Moscicki, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, San Francisco

Authority:

United States: Institutional Review Board

Study ID:

11-05580

NCT ID:

NCT01366742

Start Date:

December 1987

Completion Date:

June 2015

Related Keywords:

  • Human Papillomavirus
  • CIN 2
  • CIN 3
  • Neoplasms

Name

Location

SFSU Student Health CenterSan Francisco, California  94132
HPV Study - San Leandro OfficeSan Leandro, California  94577