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Community Awareness, Resources and Education (CARE II) Project: Project 1

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ClinicalTrials.gov Identifier: NCT02797600
Recruitment Status : Completed
First Posted : June 13, 2016
Last Update Posted : June 13, 2016
Sponsor:
Information provided by (Responsible Party):
Christopher Weghorst, Ohio State University Comprehensive Cancer Center

Tracking Information
First Submitted Date June 8, 2015
First Posted Date June 13, 2016
Last Update Posted Date June 13, 2016
Study Start Date June 2011
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 7, 2016)
Genetic variations in TGFβ ligand and receptor genes and other cancer-associated genes. [ Time Frame: Day 1 ]
The number of participants with genetic variations in TGFβ ligand and receptor genes and other cancer-associated genes with known single nucleotide polymorphisms as determined by direct sequencing and SNP PCR analyses
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: June 7, 2016)
Environmental, behavioral and socioeconomic risk factors. [ Time Frame: Day 1 ]
The number of participants with various environmental, behavioral and socioeconomic risk factors as assessed by survey data.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Community Awareness, Resources and Education (CARE II) Project: Project 1
Official Title Community Awareness, Resources and Education (CARE II) Project: Project 1
Brief Summary The study hypothesis is that the increased incidence of cervical cancer observed in Appalachian women over their non-Appalachian counterparts is due in part to inherited and somatic alterations of key components of the Transforming Growth Factor β (TGFβ) signaling pathway.
Detailed Description This project is a case control study that is designed to determine prevalence of inherited polymorphic and somatically acquired variants of key TGF-ß pathway components in a large cohort of Appalachian invasive cervical cancer (ICC) patients compared to healthy Appalachian women. It will be determined whether these genetic alterations contribute individually or in combination with other known environmental (Human Papillomavirus, Epstein-Barr Virus), behavioral (smoking), and social (stress, social networks) risk factors, to the increased susceptibility of Appalachian women to ICC development. Women will be recruited from several clinics and physician practices in West Virginia, Charleston and Appalachia Ohio and Kentucky. Participants will be women residing in these area who are 18 years and older, not pregnant, speak English, not cognitively impaired and able to provide informed consent. There will be three distinct types of women recruited into the study; 1. ARM 1 - previously treated for invasive cervical cancer; 2. ARM 2 - newly diagnosed with invasive cervical cancer; and 3. healthy controls - without a diagnosis of cervical cancer.
Study Type Observational
Study Design Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Plasma, serum, saliva samples, buccal scrapes, oral rinse, tissue.
Sampling Method Non-Probability Sample
Study Population Participants for this study will be women residing in Appalachian counties (West Virginia and Appalachia Ohio and Kentucky). There will be three distinct types of women recruited into the study; 1) prevalent invasive cervical cancer cases; 2) newly diagnosed invasive cervical cancer cases; and 3) healthy controls (women without a diagnosis of any type of cancer). Women will be recruited from several clinics and physician practices in Appalachian counties.
Condition Cervical Cancer
Intervention
  • Behavioral: Questionnaires
    Questionnaires will be used to obtain self-reported demographic, behavioral, social, family and medical history, and quality of life data. The questions are standardized and taken from either nationally recognized surveys, CARE I surveys, or represent validated survey items.
  • Other: Biological Samples
    All biological samples will be collected at the time of the clinical Pap smear for the controls, and will be collected for the Arm 2 (newly diagnosed) during a scheduled clinic visit. For those individuals in Arm 1, biological samples will be collected during a scheduled visit with the research staff.
    Other Name: specimen collection
Study Groups/Cohorts
  • ARM I
    Woman residing in Appalachian counties who have prevalent invasive cervical cancer. Invasive cervical cancer cases participants will include women previously and currently treated for ICC during the past 10 years. Questionnaires will be used to obtain self-reported demographic, behavioral, social, family and medical history, and quality of life data. Biological samples will be collected during a scheduled visit with the research staff.
    Interventions:
    • Behavioral: Questionnaires
    • Other: Biological Samples
  • ARM II
    Woman residing in Appalachian counties who are newly diagnosed with invasive cervical cancer(ICC). Newly diagnosed with ICC, and currently being treated for ICC. Questionnaires will be used to obtain Questionnaires will be used to obtain self-reported demographic, behavioral, social, family and medical history, and quality of life data. All biological samples will be collected during a scheduled clinic visit.
    Interventions:
    • Behavioral: Questionnaires
    • Other: Biological Samples
  • ARM III
    Healthy controls (women without a diagnosis of any type of cancer. Healthy controls will be women who are coming into one of the participating clinic or physician practice for a routine Pap test. Questionnaires will be used to obtain Questionnaires will be used to obtain self-reported demographic, behavioral, social, family and medical history, and quality of life data. All biological samples will be collected at the time of the clinical Pap smear.
    Interventions:
    • Behavioral: Questionnaires
    • Other: Biological Samples
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 7, 2016)
285
Original Actual Enrollment Same as current
Actual Study Completion Date April 2015
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 18 years and older
  • Patients previously or newly diagnosed with invasive cervical cancer
  • healthy women without a diagnosis of any type of cancer
  • English speaking
  • Able to provide informed consent, biological and questionnaire data.

Exclusion Criteria:

  • Pregnant women
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02797600
Other Study ID Numbers OSU-10095
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Christopher Weghorst, Ohio State University Comprehensive Cancer Center
Study Sponsor Ohio State University Comprehensive Cancer Center
Collaborators Not Provided
Investigators
Principal Investigator: Christopher Weghorst, PhD Ohio State University
PRS Account Ohio State University Comprehensive Cancer Center
Verification Date June 2016