NCT00511641

Brief Summary

The goal of this research study is to learn more about how women feel about an ovarian cancer screening program that involves getting a blood test to measure CA 125 levels. This includes finding out about women's quality of life and whether they are concerned or worried about their risk of developing cancer. This study also seeks to find out whether elevated CA 125 levels affect participants in terms of cancer worries or concerns.

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
1,342

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2002

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

February 12, 2002

Completed
5.5 years until next milestone

First Submitted

Initial submission to the registry

August 3, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 6, 2007

Completed
12.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
Last Updated

June 24, 2019

Status Verified

June 1, 2019

Enrollment Period

18 years

First QC Date

August 3, 2007

Last Update Submit

June 20, 2019

Conditions

Ovarian Cancer

Keywords

Ovarian CancerCancer ScreeningQuality of LifeQuestionnaireScreeningSurvey

Outcome Measures

Primary Outcomes (1)

  • Mean Scores on Each Quality of Life Instrument (Surveys)

    Descriptive, written, self-report, quality of life instruments used.

    Baseline quality of life data collected, and if/when return to clinic due to abnormal test results.

Secondary Outcomes (1)

  • To find out whether elevated CA 125 levels affect participants in terms of cancer worries or concerns.

    8 Years

Study Arms (1)

Low Risk OVCA

Patient that is participating in an ovarian cancer (OVCA) screening program.

Behavioral: Questionnaire

Interventions

QuestionnaireBEHAVIORAL

Questionnaires lasting up to 30 minutes.

Also known as: Survey
Low Risk OVCA

Eligibility Criteria

Age50 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Female UT MDACC Patients, over 50 years of age, participating in an ovarian cancer screening program.

You may qualify if:

  • Women enrolled on protocol ID01-022
  • Women \> 50 years of age
  • Postmenopausal (\> 12 months amenorrhea)
  • Willingness to return to clinic for annual blood tests, or earlier if indicated
  • Willingness to undergo transvaginal ultrasound if indicated
  • Women who speak and read English

You may not qualify if:

  • Women ineligible to be enrolled on protocol ID01-022
  • Prior removal of both ovaries
  • Active non-ovarian malignancy
  • Women who have a history of non-ovarian malignancy will be eligible if they have no persistent or recurrent disease and have not received treatment for \> 12 months. They will not be excluded if they are on tamoxifen.
  • High-risk for ovarian cancer due to familial predisposition as defined by the following:
  • Known mutation in BRCA1 or BRCA2
  • Two first or second degree relatives with either ovarian cancer or pre-menopausal breast cancer
  • Ashkenazi Jewish ethnicity with one first degree or two second degree relatives with pre-menopausal breast or ovarian cancer, or if patient herself has had breast cancer.
  • Women who do not speak or read English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Diane C. Bodurka, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2007

First Posted

August 6, 2007

Study Start

February 12, 2002

Primary Completion

February 1, 2020

Study Completion

February 1, 2021

Last Updated

June 24, 2019

Record last verified: 2019-06

Locations

US(1)