Trial record 7 of 34 for:    ovarian,cancer,detection | Open 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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00757952
First received: September 22, 2008
Last updated: July 1, 2009
Last verified: June 2009
  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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00757952

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      
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: 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 July 20, 2014