Cervical Cancer
Conditions
Keywords
Appalachia
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.
Interventions
BEHAVIORALQuestionnaires
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.
OTHERBiological 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.
Sponsors
Ohio State University Comprehensive Cancer Center
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Genetic variations in TGFβ ligand and receptor genes and other cancer-associated genes. | 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
| Measure | Time frame | Description |
|---|---|---|
| Environmental, behavioral and socioeconomic risk factors. | Day 1 | The number of participants with various environmental, behavioral and socioeconomic risk factors as assessed by survey data. |
Countries
United States
Outcome results
None listed