NCT01292733

Brief Summary

The main purpose of this program is to see whether periodically measuring CA-125 (tumor marker) levels in the blood and undergoing transvaginal ultrasounds over time will be effective in the early detection of ovarian cancer.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
534

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Aug 2009

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
terminated

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

August 1, 2009

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 30, 2010

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 9, 2011

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

January 20, 2016

Status Verified

January 1, 2016

Enrollment Period

6.3 years

First QC Date

November 30, 2010

Last Update Submit

January 15, 2016

Conditions

Ovarian DiseasesOvarian Neoplasms

Keywords

Women with increased risk for developing ovarian cancerWomen diagnosed with reproductive cancerWomen with relatives who have had ovarian or breast cancer

Outcome Measures

Primary Outcomes (1)

  • Measuring for elevated levels of tumor marker CA-125 in the blood over time.

    Average expected time of 1 year

Secondary Outcomes (2)

  • Performing transvaginal ultrasounds to look for any abnormalities over time.

    Average expected time of 1 year

  • Performing health status questionnaires over time

    Average expected time of 1 year

Study Arms (1)

Ovarian Cancer Screening

EXPERIMENTAL

CA125 tumor marker, Transvaginal Ultrasound, Health Status Questionnaires

Other: Laboratory Tumor Marker AnalysisOther: Transvaginal UltrasoundOther: Health Status Questionnaire

Interventions

Laboratory Tumor Marker AnalysisOTHER

Performed every 6 months, these blood samples will be drawn to measure the concentration of CA125 tumor marker. Remaining samples will be stored in a specimen repository for use in future research for ovarian and breast cancer tumor markers.

Ovarian Cancer Screening
Transvaginal UltrasoundOTHER

Performed annually, these pelvic ultrasounds will be used used to look for 1) enlargement of one or both ovaries or 2) suspicious or indeterminate morphometric parameters, determined by the presence of intracystic papillations, and/or mural nodularity.

Ovarian Cancer Screening
Health Status QuestionnaireOTHER

Performed every 6 months, these questionnaires will ask about your health and medical history, environmental exposures, and family history.

Ovarian Cancer Screening

Eligibility Criteria

Age30 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Must meet one of the following:
  • The family contains at least two ovarian or breast cancers in the subject or first or second degree relatives of the subject.
  • The subject is of Ashkenazi Jewish ethnicity with one first degree or two second-degree relatives with breast or ovarian cancer, or subject is of Ashkenazi ancestry and has had breast cancer.
  • The subject has a male relative with breast cancer diagnosed at any age.
  • Probability of carrying a BRCA1/2 mutation given family pedigree of breast and ovarian cancers exceeds 20% (as determined by BRCAPRO 95% posterior probability interval).

You may not qualify if:

  • Prior ovarian cancer or peritoneal carcinomatosis
  • A first or second degree relative with a BRCA1/2 mutation and has tested negative for exactly the same mutation.
  • The subject has no ovaries.
  • Less than 30 years of age, unless 25-30 with BRCA I or II mutation confirmed
  • Currently pregnant
  • Currently receiving adjuvant chemotherapy or radiation therapy for cancer (excluding tamoxifen). Patients who are being treated for local disease may enroll 3 months after completion of last treatment (excluding tamoxifen).
  • Treatment (excluding tamoxifen) for prior metastatic malignancy within the past five years.
  • Intraperitoneal surgery within the last 3 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marsha Rivkin Center for Ovarian Cancer Research

Seattle, Washington, 98122, United States

Location

MeSH Terms

Conditions

Ovarian DiseasesOvarian NeoplasmsBreast Neoplasms

Condition Hierarchy (Ancestors)

Adnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System DiseasesEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Pamela Paley, MD

    Swedish Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2010

First Posted

February 9, 2011

Study Start

August 1, 2009

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

January 20, 2016

Record last verified: 2016-01

Locations

US(1)