Study of Biomarkers in Blood & Tissue Samples From Patients With Colorectal Cancer or Polyps & Patients Without Polyps

Colorectal Cancer Clinical Trial

Official title:

Cancer Care Engineering of Colorectal Cancer - OMICs Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00898378
• Other study ID #: 0808-24; IUCRO-0221
• Secondary ID: P30CA082709IUCRO
• Status: Completed
• Phase: N/A
• First received: May 9, 2009
• Last updated: September 17, 2014
• Start date: January 2009
• Est. completion date: March 2014

Study information

• Verified date: September 2014
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

RATIONALE: Studying samples of blood and tissue in the laboratory from patients with cancer, patients with colorectal polyps and from patients without polyps 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 patients without polyps (healthy volunteers).

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 patients without polyps.

• Create an OMIC profile to predict the risk of CRC based on differences observed between patients with CRC, patients with colorectal adenomatous polyps, and patients without polyps.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 551
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Healthy, no Evidence of Disease
• Precancerous Condition
• Precancerous Conditions

Intervention

Genetic:
• gene expression analysis
gene expression analysis
• polymerase chain reaction
polymerase chain reaction
• polymorphism analysis
polymorphism analysis
• protein expression analysis
protein expression analysis
• proteomic profiling
proteomic profiling

Other:
• gas chromatography
gas chromatography
• laboratory biomarker analysis
laboratory biomarker analysis
• liquid chromatography
liquid chromatography
• mass spectrometry
mass spectrometry
• questionnaire administration
questionnaire administration

Locations

Country	Name	City	State
United States	Indiana University Melvin and Bren Simon Cancer Center	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metabolomic, lipidomic, glycoproteomic, proteomic, and genomic (OMIC) profiling		End of Study	No
Primary	Creation of an OMIC profile to predict the risk of colorectal cancer (CRC)		End of Study	No
Secondary	Creation of an OMIC profile to predict response and toxicity to specific therapies for CRC		End of Study	Yes
Secondary	Identification of interactive molecular pathways that underlie the development and progression of CRC		End of Study	No