NCT00757952

Brief Summary

RATIONALE: Studying samples of exhaled breath from patients with ovarian epithelial cancer, polycystic ovarian syndrome, or endometriosis and from healthy participants in the laboratory may help doctors identify and learn more about biomarkers related to cancer. It may also help doctors find and diagnose ovarian epithelial cancer sooner, when it may be easier to treat. PURPOSE: This clinical trial is studying exhaled breath biomarkers to see how well they find ovarian epithelial cancer in patients with newly diagnosed ovarian epithelial cancer, polycystic ovarian syndrome, or endometriosis and in healthy participants.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
109

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2007

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

Status
completed

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

November 1, 2007

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 22, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 23, 2008

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

March 30, 2016

Status Verified

March 1, 2016

Enrollment Period

5.1 years

First QC Date

September 22, 2008

Last Update Submit

March 28, 2016

Conditions

Ovarian Cancer

Keywords

ovarian epithelial cancer

Outcome Measures

Primary Outcomes (3)

  • Identification of patterns of exhaled compounds in breath samples using gas chromatography Fourier transform ion cyclotron resonance mass spectrometry (GC/FT-ICR MS)

    2009-2012

  • Diagnostic accuracy of GC/FT-ICR MS in distinguishing between exhaled breath samples from patients with ovarian epithelial cancer, patients with polycystic ovarian syndrome or endometriosis, and healthy volunteers

    2009-2012

  • Diagnostic accuracy of canine scent detection in distinguishing between exhaled breath samples from patients with ovarian epithelial cancer and healthy volunteers

    2009-2012

Interventions

Fourier transform ion cyclotron resonance mass spectrometryOTHER
chromatographyOTHER
diagnostic laboratory biomarker analysisOTHER
questionnaire administrationOTHER

Eligibility Criteria

Age21 Years - 120 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

1. Histologically confirmed ovarian epithelial cancer. 2. Polycystic Ovarian Syndrome or Endometriosis 3. Healthy Controls

DISEASE CHARACTERISTICS: * Meets one of the following criteria: * Histologically confirmed ovarian epithelial cancer * Newly diagnosed disease * Diagnosis of polycystic ovarian syndrome or endometriosis * Healthy volunteer meeting all of the following criteria: * No prior ovarian cancer (including invasive ovarian epithelial cancer, fallopian tube cancer, or primary papillary serous carcinoma of the peritoneum) * No prior breast cancer (including ductal carcinoma in situ \[DCIS\]) * No prior ovarian or breast cancer (including DCIS) in any first- or second-degree relative * BRCA1 or BRCA2 mutation negative (if known) OR no first- or second-degree relative with a BRCA1 or BRCA2 mutation (if known) * No prior diagnosis of cancer PATIENT CHARACTERISTICS: * Lives in California and close to the study sampling centers * Reads and writes English, Spanish, or Chinese * Non-smoker * Willing to provide breath samples * No alcohol intake within the past 3 days PRIOR CONCURRENT THERAPY: * At least 3 days since prior Cox-2 inhibitors, vitamin E, omega-3 fatty acids, antioxidants, bromelain, coenzyme Q10, curcumin, or vitamin A

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (4)

Pine Street Foundation

San Anselmo, California, 94960-2674, United States

Location

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

California Pacific Medical Center - California Campus

San Francisco, California, 94118, United States

Location

University of Maine

Orono, Maine, 04469, United States

Location

MeSH Terms

Conditions

Ovarian NeoplasmsCarcinoma, Ovarian Epithelial

Interventions

Chromatography

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 DisordersCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Chemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Michael McCulloch, MPH, PhD

    Pine Street Foundation

    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

September 22, 2008

First Posted

September 23, 2008

Study Start

November 1, 2007

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

March 30, 2016

Record last verified: 2016-03

Locations

US(4)