Early Detection of Ovarian Cancer: GC/FT-ICR Mass Spectrometry and Canine Olfaction

• ClinicalTrials.gov Identifier: NCT00757952
• Recruitment Status: Completed
• First Posted: September 23, 2008
• Last Update Posted: March 30, 2016
• Sponsor: Pine Street Foundation
• Information provided by (Responsible Party): Michael McCulloch, Pine Street Foundation

Tracking Information

• First Submitted Date: September 22, 2008
• First Posted Date: September 23, 2008
• Last Update Posted Date: March 30, 2016
• Study Start Date: November 2007
• Actual Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 28, 2016)

• Identification of patterns of exhaled compounds in breath samples using gas chromatography Fourier transform ion cyclotron resonance mass spectrometry (GC/FT-ICR MS) [ Time Frame: 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 [ Time Frame: 2009-2012 ]
• Diagnostic accuracy of canine scent detection in distinguishing between exhaled breath samples from patients with ovarian epithelial cancer and healthy volunteers [ Time Frame: 2009-2012 ]

Original Primary Outcome Measures (submitted: September 22, 2008)

• Identification of patterns of exhaled compounds in breath samples using gas chromatography Fourier transform ion cyclotron resonance mass spectrometry (GC/FT-ICR MS)
• 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
• Diagnostic accuracy of canine scent detection in distinguishing between exhaled breath samples from patients with ovarian epithelial cancer and healthy volunteers

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Early Detection of Ovarian Cancer: GC/FT-ICR Mass Spectrometry and Canine Olfaction
• Official Title: Early Detection of Epithelial Ovarian Cancer Using Exhaled Breath Markers: GC/FT-ICR Mass Spectrometry and Canine Olfaction.

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.

Detailed Description

OBJECTIVES:

• Identify patterns of exhaled compounds in breath samples from patients with newly diagnosed ovarian epithelial cancer that are significantly and reproducibility different from those of healthy volunteers using gas chromatography Fourier transform ion cyclotron resonance mass spectrometry (GC/FT-ICR MS).
• Train five canines to discriminate between exhaled breath samples from patients with newly diagnosed ovarian epithelial cancer and healthy volunteers.
• Use both canine olfaction and GC/FT-ICR MS to distinguish between exhaled breath samples from patients with newly diagnosed ovarian epithelial cancer and patients with polycystic ovarian syndrome or endometriosis.
• Repeat breath sampling in patients with newly diagnosed ovarian epithelial cancer throughout the course of diagnosis and therapy.

OUTLINE: Exhaled breath samples are collected from patients and healthy volunteers. The samples are analyzed by gas chromatography Fourier transform ion cyclotron resonance mass spectrometry (GC/FT-ICR MS) to determine chemical compositions, identities, and predictive patterns of biomarkers in exhaled breath condensate. GC/FT-ICR MS and trained canine olfaction are used to distinguish between exhaled breath samples from patients with ovarian epithelial cancer, patients with polycystic ovarian syndrome or endometriosis, and healthy volunteers.

Patients and healthy volunteers complete questionnaires about BRCA 1 and BRCA 2 status (if known), alcohol use, smoking (including duration and type of cigarettes), physical activity (duration and type), socioeconomic status, education, county of residence, age at menopause (if applicable), age at menarche, presence of first- and second-degree family history of breast cancer or ovarian epithelial cancer, body mass index (height and weight), and co-morbidities.

• Study Type: Observational
• Study Design: Observational Model: Case-Control; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample

Study Population

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

• Condition: Ovarian Cancer

Intervention

• Other: Fourier transform ion cyclotron resonance mass spectrometry
• Other: chromatography
• Other: diagnostic laboratory biomarker analysis
• Other: questionnaire administration

• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 28, 2016): 109
• Original Estimated Enrollment (submitted: September 22, 2008): 120
• Actual Study Completion Date: December 2012
• Actual Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 21 Years to 120 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00757952
• Other Study ID Numbers: PINE-A-14183; CDR0000614811 ( Registry Identifier: PDQ (Physician Data Query) ); UCSF-H105-31440-01
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Michael McCulloch, Pine Street Foundation
• Study Sponsor: Pine Street Foundation
• Collaborators: Not Provided

Investigators

• Principal Investigator: Michael McCulloch, MPH, PhD; Pine Street Foundation

• PRS Account: Pine Street Foundation
• Verification Date: March 2016