NCT02406391

Brief Summary

In the United States, the highest incidence of cervical cancer occurs in inner city urban centers, rural areas, the deep South, Appalachia and the U.S.-Mexico border. The goal of this study is to study predictors of adherence among patients seeking care at an inner city medical center in New York City and the U.S. Mexico border for cervical cancer prevention, namely, Pap smears and colposcopy exams.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2015

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 16, 2015

Completed
16 days until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 2, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

April 10, 2015

Status Verified

April 1, 2015

Enrollment Period

1.7 years

First QC Date

March 16, 2015

Last Update Submit

April 9, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Adherence to screening, colposcopy and follow-up treatment

    A survey will be administered to patients who present for a routine Pap smear exam, a follow-up colposcopy exam. Medical records will be reviewed to document adherence to treatments post-colposcopy

    1-2 hour interview during clinic visit and review of patients' medical records during surveillance period (up to 2 years)

Eligibility Criteria

Age21 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Eligible patients who present to the gynecology clinic for a Pap smear exam or a colposcopy exam following an abnormal Pap smear.

You may qualify if:

  • women who are at least 21 years old
  • are seeking care for a Pap smear exam
  • are seeking care for a colposcopy exam for the first time
  • are not pregnant by self-report
  • are able to provide informed consent

You may not qualify if:

  • women who do not meet the above eligibility criteria
  • women who have no prior history of a hysterectomy
  • women who have previously participated in this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Brookdale University Hospital and Medical Center

Brooklyn, New York, 11212, United States

Location

University of Texas at El Paso

El Paso, Texas, 79902, United States

Location

Texas Tech University Health Science Center

El Paso, Texas, 79905, United States

Location

MeSH Terms

Conditions

Uterine Cervical NeoplasmsUterine Cervical Dysplasia

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesPrecancerous Conditions

Study Officials

  • Michele Follen, MD, PhD

    Brookdale University Hospital and Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Leonid Fradkin, PhD

CONTACT

Thelma Carrillo

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair of Department of Obstetrics and Gynecology

Study Record Dates

First Submitted

March 16, 2015

First Posted

April 2, 2015

Study Start

April 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2017

Last Updated

April 10, 2015

Record last verified: 2015-04

Locations