View Clinical Trial (Medical Research Study)
Early Detection of Epithelial Ovarian Cancer Using Exhaled Breath Markers: GC/FT-ICR Mass Spectrometry and Canine Olfaction.
| City: |
|
Orono |
| State: |
|
Maine |
| Zip Code: |
|
04469 |
| Conditions: |
|
Ovarian Cancer |
| 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.
|
| Study Summary: |
|
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.
|
| 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
|
| NCT ID: |
|
NCT00757952 |
| Primary Contact: |
|
Principal Investigator
Michael McCulloch, MPH, PhD
Pine Street Foundation
|
| Backup Contact: |
|
N/A |
| Location Contact: |
|
Orono, Maine 04469
United States
Touradj Solouki, PhD
Phone: 415-342-0886
Site Status: Recruiting |
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
May 21, 2013 |
| Modifications to this listing: |
|
Only selected fields are shown, please use the link
below to view all information about this clinical trial. |
|
Click to view Full Listing
|