Ovarian Cancer Clinical Trial

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

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.

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Full 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.

View Eligibility Criteria

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

Study is for people with:

Ovarian Cancer

Estimated Enrollment:

109

Study ID:

NCT00757952

Recruitment Status:

Completed

Sponsor:

Pine Street Foundation

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There are 4 Locations for this study

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Pine Street Foundation
San Anselmo California, 94960, United States
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco California, 94115, United States
California Pacific Medical Center - California Campus
San Francisco California, 94118, United States
University of Maine
Orono Maine, 04469, United States

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Estimated Enrollment:

109

Study ID:

NCT00757952

Recruitment Status:

Completed

Sponsor:


Pine Street Foundation

How clear is this clinincal trial information?

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