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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cervical Cancer

Intervention / Treatment
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* Behavioral: Questionnaires
* Other: Biological Samples


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ARM I<br>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<br>* 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.<br>Other: Biological Samples<br>* 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.<br>* Other names: specimen collection;|
| ARM II<br>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<br>* 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.<br>Other: Biological Samples<br>* 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.<br>* Other names: specimen collection;|
| ARM III<br>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<br>* 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.<br>Other: Biological Samples<br>* 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.<br>* Other names: specimen collection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Genetic variations in TGFβ ligand and receptor genes and other cancer-associated genes. | 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 | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Environmental, behavioral and socioeconomic risk factors. | The number of participants with various environmental, behavioral and socioeconomic risk factors as assessed by survey data. | Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Appalachia