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

NCT02797600 | Completed

• 1 other identifier: OSU-10095
• Study Type: observational
• Target: 285
• Locations: 1 country
• Sites: 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.

Conditions

Cervical Cancer

Keywords

Appalachia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Environmental, behavioral and socioeconomic risk factors.

  Day 1

Study Arms (3)

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; 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.

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.

Behavioral: Questionnaires; Other: Biological Samples

Interventions

Questionnaires BEHAVIORAL

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.

ARM I; ARM II; ARM III

Biological Samples OTHER

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.

Also known as: specimen collection

ARM I; ARM II; ARM III

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Pregnant women

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Related Links

• The Jamesline

Biospecimen

Retention: SAMPLES WITH DNA

Plasma, serum, saliva samples, buccal scrapes, oral rinse, tissue.

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Surveys and Questionnaires; Specimen Handling

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Electra Paskett, PhD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 8, 2015
• First Posted: June 13, 2016
• Study Start: June 1, 2011
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: April 2, 2024

Record last verified: 2024-04

Locations

US (1)