Free Fatty Acid Metabolite Biomarkers for Cancer

Breast Cancer Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01692951
• Other study ID #: 12-306
• Status: Recruiting
• Phase: N/A
• First received: September 21, 2012
• Last updated: May 14, 2014
• Start date: August 2012
• Est. completion date: August 2015

Study information

• Verified date: May 2014
• Source: The Cleveland Clinic
• Contact: Daniel Sessler, M.D.
• Phone: 216-444-4900
• Email: ds[@]or.org
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

Surgical removal of tumor at an early stage remains the primary treatment for most cancers. However, there is currently no reliable screening blood test for detection of lung, colon, or breast cancer. The Specific Aims are to: 1) assess the diagnostic accuracy of six FFA metabolites to detect lung and colon cancer in surgical patients; 2)determine the rate and extent to which FFA metabolites decrease over time after surgery for lung and colon cancer; and, 3)determine the positive and negative predictive values and overall test accuracy for diagnostic prostate and breast biopsies.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1176
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Colon Cancer
• Lung Cancer
• Prostate Cancer

Intervention

Other:
• blood sample
We will obtain daily blood samples from cancer patients enrolled under Specific Aim 1 while they remain hospitalized, and an additional sample one week after surgery.

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estimate predictive values for each type of cancer.	The primary outcome for Specific Aim 1 will be the area under the ROC curve and 95% confidence interval for each metabolite.	Day 1	No
Primary	Determine Biomarker reduction in blood samples	One-week biomarker reduction from the preoperative value for each cancer.	7 days	No
Primary	Evaluate predictive values for each type of cancer.	To determine the area under the receiver operating characteristic curve (i.e., AUC) predicting prostate and breast cancer for each FFA metabolite, as well as the diagnostic test parameters: sensitivity, specificity, positive and negative predictive values.	Day 1	No