Clinical trial NCT02797600: Community Awareness, Resources and Education (CARE II) Project: Project 1
Official title: Community Awareness, Resources and Education (CARE II) Project: Project 1
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Cancer
Keywords: Appalachia
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2016-06-13
Enrollment: 285
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Genetic variations in TGFβ ligand and receptor genes and other cancer-associated genes.
timeFrame: Day 1
Secondary outcomes:
measure: Environmental, behavioral and socioeconomic risk factors.
timeFrame: Day 1
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: Electra Paskett, PhD
role: PRINCIPAL_INVESTIGATOR
References: