Free Fatty Acid Metabolite Biomarkers for Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by The Cleveland Clinic
Sponsor:
Information provided by (Responsible Party):
d sessler, Outcomes Research Consortium
ClinicalTrials.gov Identifier:
NCT01692951
First received: September 21, 2012
Last updated: May 14, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Prostate Cancer
Breast Cancer
Colon Cancer
Lung Cancer
Other: blood sample

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • Estimate predictive values for each type of cancer. [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    The primary outcome for Specific Aim 1 will be the area under the ROC curve and 95% confidence interval for each metabolite.

  • Determine Biomarker reduction in blood samples [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    One-week biomarker reduction from the preoperative value for each cancer.

  • Evaluate predictive values for each type of cancer. [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples Without DNA

Blood will be sampled for FFA metabolites


Estimated Enrollment: 1176
Study Start Date: August 2012
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Breast cancer patients
Breast cancer patients and controls
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.
prostate cancer patients
Prostate cancer patients and controls
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.
lung cancer patients 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.
colon cancer patients 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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Prostate cancer occurs only in men; conversely, breast cancer is almost exclusively a disease of women. The non-cancer control patients for each type of cancer will be of the same sex. We propose to study roughly comparable numbers of prostate and breast cancer patients (and controls). Colon and lung cancers occur at similar rates in men and women. We thus expect that about half of our total enrollment will be female.

Criteria

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
  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: NCT01692951

Contacts
Contact: Daniel Sessler, M.D. 216-444-4900 ds@or.org
Contact: Roberta Johnson 216-444-9950 johnsor13@cf.org

Locations
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Daniel Sessler, M.D. The Cleveland Clinic
  More Information

No publications provided

Responsible Party: d sessler, MD, Outcomes Research Consortium
ClinicalTrials.gov Identifier: NCT01692951     History of Changes
Other Study ID Numbers: 12-306
Study First Received: September 21, 2012
Last Updated: May 14, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Colonic Neoplasms
Lung Neoplasms
Prostatic Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on August 20, 2014