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

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00757952
• Other study ID #: PINE-A-14183
• Secondary ID: CDR0000614811UCS
• Status: Completed
• Phase: N/A
• First received: September 22, 2008
• Last updated: March 28, 2016
• Start date: November 2007
• Est. completion date: December 2012

Study information

• Verified date: March 2016
• Source: Pine Street Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board: Ethical and Independent Review Services, 100 Tamal Plaza # 158, Corte Madera, CA 94925
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 120 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Other:
• Fourier transform ion cyclotron resonance mass spectrometry

• chromatography

• diagnostic laboratory biomarker analysis

• questionnaire administration

Locations

Country	Name	City	State
United States	University of Maine	Orono	Maine
United States	Pine Street Foundation	San Anselmo	California
United States	California Pacific Medical Center - California Campus	San Francisco	California
United States	UCSF Helen Diller Family Comprehensive Cancer Center	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Pine Street Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	Diagnostic accuracy of canine scent detection in distinguishing between exhaled breath samples from patients with ovarian epithelial cancer and healthy volunteers		2009-2012	No