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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

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.

Condition or disease Intervention/treatment
Cervical Cancer Behavioral: Questionnaires Other: Biological Samples

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.

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Study Type : Observational
Actual Enrollment : 285 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Community Awareness, Resources and Education (CARE II) Project: Project 1
Study Start Date : June 2011
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Group/Cohort Intervention/treatment
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.
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

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.
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

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.
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples With DNA
Plasma, serum, saliva samples, buccal scrapes, oral rinse, tissue.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02797600


Locations
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United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Investigators
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Principal Investigator: Christopher Weghorst, PhD Ohio State University

Additional Information:
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Responsible Party: Christopher Weghorst, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02797600     History of Changes
Other Study ID Numbers: OSU-10095
First Posted: June 13, 2016    Key Record Dates
Last Update Posted: June 13, 2016
Last Verified: June 2016

Keywords provided by Christopher Weghorst, Ohio State University Comprehensive Cancer Center:
Appalachia

Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female