Exhaled Breath Biomarkers in Finding Ovarian Epithelial Cancer in Patients With Newly Diagnosed Ovarian Epithelial Cancer, Polycystic Ovarian Syndrome, or Endometriosis and in Healthy Participants
Recruitment status was Recruiting
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Purpose
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 |
|---|---|
|
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: | Primary Purpose: Diagnostic |
| Official Title: | Early Detection of Epithelial Ovarian Cancer Using Exhaled Breath Markers: GC/FT-ICR Mass Spectrometry and Canine Olfaction. |
- Identification of patterns of exhaled compounds in breath samples using gas chromatography Fourier transform ion cyclotron resonance mass spectrometry (GC/FT-ICR MS) [ Designated as safety issue: No ]
- 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 [ Designated as safety issue: No ]
- Diagnostic accuracy of canine scent detection in distinguishing between exhaled breath samples from patients with ovarian epithelial cancer and healthy volunteers [ Designated as safety issue: No ]
| Estimated Enrollment: | 120 |
| Study Start Date: | November 2007 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
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.
Eligibility| 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
- 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
Contacts and Locations| United States, California | |
| Pine Street Foundation | Recruiting |
| San Anselmo, California, United States, 94960-2674 | |
| Contact: Michael McCulloch, MPH, PhD 415-407-1357 | |
| California Pacific Medical Center - California Campus | Recruiting |
| San Francisco, California, United States, 94118 | |
| Contact: Jenta Shen, MD, PhD 415-668-0900 jentashen@aol.com | |
| 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 |
More Information
Additional Information:
No publications provided
| Responsible Party: | Michael McCulloch, Pine Street Foundation |
| ClinicalTrials.gov Identifier: | NCT00757952 History of Changes |
| Other Study ID Numbers: | CDR0000614811, PINE-A-14183, UCSF-H105-31440-01 |
| Study First Received: | September 22, 2008 |
| Last Updated: | July 1, 2009 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
ovarian epithelial cancer |
Additional relevant MeSH terms:
|
Ovarian Neoplasms Neoplasms, Glandular and Epithelial Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Genital Neoplasms, Female Urogenital Neoplasms |
Ovarian Cysts Neoplasms by Histologic Type Polycystic Ovary Syndrome Adnexal Diseases Genital Diseases, Female Endocrine System Diseases Gonadal Disorders Cysts |
ClinicalTrials.gov processed this record on May 23, 2013