Clinical trial · Observational
Quality of Life Associated With a Low-Risk Screening Program for Ovarian Cancer
NCT00511641CI-TRIAL-00039177unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Questionnaire | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Low Risk OVCA
- description
- Patient that is participating in an ovarian cancer (OVCA) screening program.
- interventionNames
- Behavioral: Questionnaire
Primary outcomes (1)
- measure
- Mean Scores on Each Quality of Life Instrument (Surveys)
- timeFrame
- Baseline quality of life data collected, and if/when return to clinic due to abnormal test results.
- description
- Descriptive, written, self-report, quality of life instruments used.
Secondary outcomes (1)
- measure
- To find out whether elevated CA 125 levels affect participants in terms of cancer worries or concerns.
- timeFrame
- 8 Years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria:
1. 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
2. Women who speak and read English
Exclusion Criteria:
1. 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.
2. Women who do not speak or read EnglishReferences
Publications (0)
Data not yet available
No reference posted for this study.