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N/A
18 Years
80 Years
Open (Enrolling)
Both
Prostate Cancer, Breast Cancer, Colon Cancer, Lung Cancer

Thank you

Trial Information


Inclusion Criteria:



- potential breast cancer

- patients who have early stages of breast cancer prior to surgery potential prostate
cancer lung cancer colon cancer

Exclusion Criteria:

- 1) Patients will be excluded from enrollment if they have severe liver disease (ALT
three times the upper limit of normal). Patients will also be excluded who have taken
aspirin or COX inhibitors within 48 hours of surgery. 2) Patients will be excluded if
a pathologic diagnosis is already available,from a previous needle biopsy
(coordinator will remain blinded). 3) Patients will be excluded have received
pre-procedure chemotherapy or radiotherapy

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

Estimate predictive values for each type of cancer.

Outcome Description:

The primary outcome for Specific Aim 1 will be the area under the ROC curve and 95% confidence interval for each metabolite.

Outcome Time Frame:

Day 1

Safety Issue:

No

Principal Investigator

Daniel Sessler, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Cleveland Clinic

Authority:

United States: Food and Drug Administration

Study ID:

12-306

NCT ID:

NCT01692951

Start Date:

August 2012

Completion Date:

August 2014

Related Keywords:

  • Prostate Cancer
  • Breast Cancer
  • Colon Cancer
  • Lung Cancer
  • Breast Neoplasms
  • Colonic Neoplasms
  • Lung Neoplasms
  • Prostatic Neoplasms

Name

Location
Cleveland Clinic Cleveland, Ohio  44195