Community Awareness, Resources and Education (CARE II): Project 3

NCT01299714 | Completed DMC

• 2 other identifiers: OSU-10096P50CA105632
• Study Type: observational
• Target: 191
• Locations: 1 country
• Sites: 4

Brief Summary

Researchers at The Ohio State University and the University of Michigan are working together to understand cancer of the cervix. One of the areas they are studying is how stress you may experience in your life effects the way you respond to GARDASIL®. GARDASIL® is a vaccine approved by the Food and Drug Administration (FDA) to prevent some types of Human Papillomavirus (HPV) infection which can cause cancer of the cervix. Participants are being recruited from the Appalachian region of Ohio.

Conditions

Uterine Cervical Cancer

Keywords

Human Papilloma Virus; vaccine; stress; cervical cancer; GARDASIL

Outcome Measures

Primary Outcomes (1)

• serum antibody levels for HPV 6,11,16 and 18

  12 months

Secondary Outcomes (3)

• serum antibody levels for Epstein-Barr Virus (EBV)

  baseline

• Center for Epidemiological Studies - Depression (CES-D) Scale Score

  12 months

• perceived stress

  12-months

Eligibility Criteria

• Age: 18 Years - 26 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be female, aged 18 - 26 years, residing in an Appalachian region, with no history of HPV vaccination.

You may qualify if:

• Female
• years of age
• Resident of an Appalachian county
• Intact cervix
• Able to read and understand English
• Cognitively able to provide informed consent
• Willing to come for four clinic visits

You may not qualify if:

• Prior history of cervical cancer
• Prior history of a cervical lesion treated with cryotherapy or any form of surgical removal of a portion of the cervix to treat CIN
• No cervix
• Pregnant or planning to become pregnant in the next year
• History of immune disorder: auto-immune, primary immune or acquired
• Any contra-indications for the GARDASIL® vaccine series
• Taking immune suppressive medications
• Any prior exposure to an HPV vaccine of any type
• Planning to move out of the immediate area in the next year

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator
• University of Michigan: collaborator
• Merck Sharp & Dohme LLC: collaborator

Study Sites (4)

Unknown Facility

Athens, Ohio, 45701, United States

Location

Unknown Facility

Gallipolis, Ohio, 45631, United States

Location

Unknown Facility

Logan, Ohio, 43138, United States

Location

Unknown Facility

Pomeroy, Ohio, 45769, United States

Location

Related Links

• CARE: Project 3 Study

Biospecimen

Retention: SAMPLES WITH DNA

serum, Pap specimen, cervical specimen for HPV analysis, oral rinse specimen, saliva specimen

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Mack T Ruffin, IV, MD, MPH

  University of Michigan

  PRINCIPAL INVESTIGATOR

• Electra D Paskett, PhD

  Ohio State University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Marion N. Rowley Professor of Cancer Research and Director-Division of Cancer Prevention and Control

Study Record Dates

• First Submitted: February 15, 2011
• First Posted: February 18, 2011
• Study Start: February 1, 2011
• Primary Completion: November 1, 2014
• Study Completion: April 1, 2015
• Last Updated: April 25, 2018

Record last verified: 2018-04

Locations

US (4)