Full Text View
Tabular View
No Study Results Posted
Related Studies
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
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), June 2009
First Received: September 22, 2008   Last Updated: July 1, 2009   History of Changes
Sponsored by: Pine Street Foundation
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00757952
  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: Diagnostic, Active Control
Official Title: Early Detection of Epithelial Ovarian Cancer Using Exhaled Breath Markers: GC/FT-ICR Mass Spectrometry and Canine Olfaction.

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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)
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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00757952

Locations
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        
Sponsors and Collaborators
Pine Street Foundation
Investigators
Principal Investigator: Michael McCulloch, MPH, PhD Pine Street Foundation
  More Information

Additional Information:
No publications provided

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

Keywords provided by National Cancer Institute (NCI):
ovarian epithelial cancer

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on September 10, 2009