Study of Biomarkers Using Blood and Tissue Samples From Patients With Colorectal Cancer or Colorectal Polyps and From Healthy Volunteers - Full Text View

Sponsors and Collaborators:	Indiana University Melvin and Bren Simon Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00898378

Purpose

RATIONALE: Studying samples of blood and tissue in the laboratory from patients with cancer and from healthy volunteers may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is looking at biomarkers in blood and tissue samples from patients with colorectal cancer or colorectal polyps and from healthy volunteers.

Condition	Intervention
Colorectal Cancer Healthy, no Evidence of Disease Precancerous/Nonmalignant Condition	Genetic: gene expression analysis Genetic: polymerase chain reaction Genetic: polymorphism analysis Genetic: protein expression analysis Genetic: proteomic profiling Other: gas chromatography Other: laboratory biomarker analysis Other: liquid chromatography Other: mass spectrometry Other: questionnaire administration

Study Type:	Observational
Official Title:	Cancer Care Engineering of Colorectal Cancer - OMICs Pilot Study

Resource links provided by NLM:

MedlinePlus related topics: Cancer Colorectal Cancer

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Metabolomic, lipidomic, glycoproteomic, proteomic, and genomic (OMIC) profiling [ Designated as safety issue: No ]
Creation of an OMIC profile to predict the risk of colorectal cancer (CRC) [ Designated as safety issue: No ]

Secondary Outcome Measures:

Creation of an OMIC profile to predict response and toxicity to specific therapies for CRC [ Designated as safety issue: Yes ]
Identification of interactive molecular pathways that underlie the development and progression of CRC [ Designated as safety issue: No ]

Estimated Enrollment:	270
Study Start Date:	January 2009
Estimated Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Primary

Perform metabolomic, lipidomic, glycoproteomic, proteomic, and genomic (OMIC) profiling using blood and tissue samples from patients with colorectal cancer (CRC) or colorectal adenomatous polyps and from healthy volunteers.
Create an OMIC profile to predict the risk of CRC based on differences observed between patients with CRC, patients with colorectal adenomatous polyps, and healthy volunteers.

Secondary

Create an OMIC profile to predict response and toxicity to specific chemotherapies, biological therapies, and radiotherapy for CRC.
Utilize a novel knowledge discovery tool (BioMap) based on literature mining and, in the future, utilize the results of the OMIC analyses to identify interactive molecular pathways that underlie the development and progression of CRC.

OUTLINE: Patients with locally advanced or metastatic colorectal cancer are stratified according to treatment (first-line chemotherapy with fluorouracil [5-FU]/oxaliplatin or 5-FU/irinotecan vs second- or third-line chemotherapy with irinotecan only vs biological therapy with bevacizumab vs biological therapy with cetuximab vs radiotherapy).

Blood and tissue samples are collected periodically for laboratory studies. Samples are analyzed for metabolomics by nuclear magnetic resonance, gas chromatography, liquid chromatography, and mass spectrometry; lipidomics, proteomics, and glycoproteomics by liquid chromatography and mass spectrometry; and genomics (single nucleotide polymorphism biomarkers) by PCR. Vitamin D status is also assessed.

Patients complete diet-history and lifestyle questionnaires at baseline and once a year for 2 years. Healthy volunteers complete these questionnaires only at baseline.

After completion of study, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. Healthy volunteers are not followed after study completion.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

DISEASE CHARACTERISTICS:

Meets 1 of the following criteria:
- Diagnosis of one of the following:
  - Stage I or II colorectal cancer (CRC)*
    - Planning to undergo surgery only
  - Stage III CRC*
    - Planning to undergo surgery followed by adjuvant chemotherapy with or without neoadjuvant chemoradiotherapy
  - Stage IV CRC
    - Planning to undergo chemotherapy and biologic therapy (bevacizumab, cetuximab, or panitumumab)
  - Colorectal adenomatous polyps
    - Planning to undergo colonoscopy
- Healthy volunteer
  - Planning to undergo colonoscopy NOTE: *Patients with previously resected stage II or III CRC are eligible provided they undergo blood sample collection prior to starting chemotherapy

PATIENT CHARACTERISTICS:

Not pregnant
Able to undergo an 8-hour overnight fast prior to metabolomic testing
Able to attend follow-up or treatment visits for up to 24 months for collection of blood samples
No prior or concurrent invasive cancer other than CRC (for patients with CRC)
No prior invasive cancer and no first-degree relative with a known history of CRC (for healthy volunteers and patients with colorectal polyps)

PRIOR CONCURRENT THERAPY:

See Disease Characteristics

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00898378

Locations

United States, Indiana
Indiana University Melvin and Bren Simon Cancer Center	Recruiting
Indianapolis, Indiana, United States, 46202-5289
Contact: Clinical Trials Office - Indiana University Cancer Center 317-274-2552
Methodist Cancer Center at Methodist Hospital	Recruiting
Indianapolis, Indiana, United States, 46206
Contact: Elena G. Chiorean 317-278-6942
Riley's Children Cancer Center at Riley Hospital for Children	Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Elena G. Chiorean 317-278-6942
Spring Mill Medical Center	Recruiting
Indianapolis, Indiana, United States, 46290
Contact: Elena G. Chiorean 317-278-6942
William N. Wishard Memorial Hospital	Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Contact Person 317-639-6671

Sponsors and Collaborators

Indiana University Melvin and Bren Simon Cancer Center

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Elena G. Chiorean, MD

Indiana University Melvin and Bren Simon Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Indiana University Melvin and Bren Simon Cancer Center ( Elena G. Chiorean )
Study ID Numbers:	CDR0000632491, IUMC-IUCRO-0221
Study First Received:	May 9, 2009
Last Updated:	May 9, 2009
ClinicalTrials.gov Identifier:	NCT00898378 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

healthy, no evidence of disease
stage I colon cancer
stage II colon cancer
stage III colon cancer
stage IV colon cancer
stage I rectal cancer

stage II rectal cancer
stage III rectal cancer
stage IV rectal cancer
recurrent rectal cancer
recurrent colon cancer
adenomatous polyp

Study placed in the following topic categories:

Digestive System Neoplasms
Precancerous Conditions
Rectal Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Rectal Neoplasm
Polyps
Healthy
Intestinal Diseases

Rectal Diseases
Recurrence
Intestinal Neoplasms
Rectal Cancer
Digestive System Diseases
Gastrointestinal Neoplasms
Colorectal Neoplasms
Adenomatous Polyps

Additional relevant MeSH terms:

Neoplasms
Digestive System Diseases
Neoplasms by Site
Digestive System Neoplasms
Precancerous Conditions
Gastrointestinal Diseases

Colonic Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Colorectal Neoplasms

ClinicalTrials.gov processed this record on September 11, 2009