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

NCT00898378 | Completed DMC

• 3 other identifiers: 0808-24; IUCRO-0221P30CA082709IUCRO-0221
• Study Type: observational
• Target: 551
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Colorectal Cancer; Healthy, no Evidence of Disease; Precancerous Condition

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Metabolomic, lipidomic, glycoproteomic, proteomic, and genomic (OMIC) profiling

  End of Study

• Creation of an OMIC profile to predict the risk of colorectal cancer (CRC)

  End of Study

Secondary Outcomes (2)

• Creation of an OMIC profile to predict response and toxicity to specific therapies for CRC

  End of Study

• Identification of interactive molecular pathways that underlie the development and progression of CRC

  End of Study

Study Arms (3)

Colorectal Cancer Patients

Patients with stages I/II, III and IV colorectal cancer

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

Colorectal Polyps Patients

Patients with adenomatous polyp(s) after colonoscopy.

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

Healthy Controls

No abnormalities after colonoscopy.

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

Interventions

gene expression analysis GENETIC

gene expression analysis

Colorectal Cancer Patients; Colorectal Polyps Patients; Healthy Controls

polymerase chain reaction GENETIC

polymerase chain reaction

Colorectal Cancer Patients; Colorectal Polyps Patients; Healthy Controls

polymorphism analysis GENETIC

polymorphism analysis

Colorectal Cancer Patients; Colorectal Polyps Patients; Healthy Controls

protein expression analysis GENETIC

protein expression analysis

Colorectal Cancer Patients; Colorectal Polyps Patients; Healthy Controls

proteomic profiling GENETIC

proteomic profiling

Colorectal Cancer Patients; Colorectal Polyps Patients; Healthy Controls

gas chromatography OTHER

gas chromatography

Colorectal Cancer Patients; Colorectal Polyps Patients; Healthy Controls

laboratory biomarker analysis OTHER

laboratory biomarker analysis

Colorectal Cancer Patients; Colorectal Polyps Patients; Healthy Controls

liquid chromatography OTHER

liquid chromatography

Colorectal Cancer Patients; Colorectal Polyps Patients; Healthy Controls

mass spectrometry OTHER

mass spectrometry

Colorectal Cancer Patients; Colorectal Polyps Patients; Healthy Controls

questionnaire administration OTHER

questionnaire administration

Colorectal Cancer Patients; Colorectal Polyps Patients; Healthy Controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects will be recruited via oncology, gastroenterology and surgical oncology clinics at Indiana University Medical Center. Healthy controls will be subjects without any abnormalities after a colonoscopy. Subjects with polyps will be those whose colonoscopy identifies adenomatous polyps (informed consent will be signed first and samples will be collected; after colonoscopy the samples will be identified as "healthy" or "polyps").

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Indiana University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202-5289, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Biospecimens will be analyzed to study metabolimics, lipidomics, genomics, glycoproteomics, global proteomics and Vitamin D status.

MeSH Terms

Conditions

Colorectal Neoplasms; Precancerous Conditions; Colonic Neoplasms; Rectal Neoplasms; Adenomatous Polyps

Interventions

Gene Expression Profiling; Polymerase Chain Reaction; Amplified Fragment Length Polymorphism Analysis; Chromatography, Gas; Chromatography, Liquid; Mass Spectrometry

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Genetic Techniques; Investigative Techniques; Nucleic Acid Amplification Techniques; DNA Fingerprinting; Chromatography; Chemistry Techniques, Analytical

Study Officials

• Patrick J Loehrer, MD

  Indiana University Melvin and Bren Simon Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2009
• First Posted: May 12, 2009
• Study Start: January 1, 2009
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: September 18, 2014

Record last verified: 2014-09

Locations

US (1)