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Sponsored by: |
Pine Street Foundation |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00757952 |
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.
Condition | Intervention |
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Ovarian Cancer |
Other: Fourier transform ion cyclotron resonance mass spectrometry Other: chromatography Other: diagnostic laboratory biomarker analysis Other: questionnaire administration |
Study Type: | Interventional |
Study Design: | Diagnostic, Active Control |
Official Title: | Early Detection of Epithelial Ovarian Cancer Using Exhaled Breath Markers: GC/FT-ICR Mass Spectrometry and Canine Olfaction. |
Estimated Enrollment: | 120 |
Study Start Date: | November 2007 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
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.
Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
DISEASE CHARACTERISTICS:
Meets one of the following criteria:
Histologically confirmed ovarian epithelial cancer
Healthy volunteer meeting all of the following criteria:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, California | |
California Pacific Medical Center - California Campus | Recruiting |
San Francisco, California, United States, 94118 | |
Contact: Jenta Shen, MD, PhD 415-668-0900 jentashen@aol.com | |
Pine Street Foundation | Recruiting |
San Anselmo, California, United States, 94960-2674 | |
Contact: Michael McCulloch, MPH, PhD 415-407-1357 | |
UCSF Helen Diller Family Comprehensive Cancer Center | Recruiting |
San Francisco, California, United States, 94115 | |
Contact: Clinical Trials Office - UCSF Helen Diller Family Comprehensi 877-827-3222 | |
United States, Maine | |
University of Maine | Recruiting |
Orono, Maine, United States, 04469 | |
Contact: Touradj Solouki, PhD 415-342-0886 |
Principal Investigator: | Michael McCulloch, MPH, PhD | Pine Street Foundation |
Responsible Party: | Pine Street Foundation ( Michael McCulloch ) |
Study ID Numbers: | CDR0000614811, PINE-A-14183, UCSF-H105-31440-01 |
Study First Received: | September 22, 2008 |
Last Updated: | July 1, 2009 |
ClinicalTrials.gov Identifier: | NCT00757952 History of Changes |
Health Authority: | Unspecified |
ovarian epithelial cancer |
Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases Endometriosis Urogenital Neoplasms Healthy Ovarian Diseases |
Ovarian Epithelial Cancer Polycystic Ovarian Syndrome Genital Diseases, Female Signs and Symptoms Polycystic Ovary Syndrome Ovarian Cancer Endocrinopathy Endocrine Gland Neoplasms |
Genital Diseases, Female Neoplasms Neoplasms by Site Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female |
Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases Adnexal Diseases Endocrine Gland Neoplasms |