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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA082709 | U.S. NIH Grant/Contract | View source | |
| IUCRO-0221 | Other Identifier | Indiana University Cancer Center |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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).
OBJECTIVES:
Primary
Secondary
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Colorectal Cancer Patients | Patients with stages I/II, III and IV colorectal cancer |
| |
| Colorectal Polyps Patients | Patients with adenomatous polyp(s) after colonoscopy. |
| |
| Healthy Controls | No abnormalities after colonoscopy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gene expression analysis | Genetic | gene expression analysis |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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DISEASE CHARACTERISTICS:
Meets 1 of the following criteria:
Diagnosis of one of the following:
Stage I or II colorectal cancer (CRC)*
Stage III CRC*
Stage IV CRC
Colorectal adenomatous polyps
Healthy volunteer
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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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").
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| Name | Affiliation | Role |
|---|---|---|
| Patrick J Loehrer, MD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Melvin and Bren Simon Cancer Center | Indianapolis | Indiana | 46202-5289 | United States |
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Biospecimens will be analyzed to study metabolimics, lipidomics, genomics, glycoproteomics, global proteomics and Vitamin D status.
| polymerase chain reaction | Genetic | polymerase chain reaction |
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| polymorphism analysis | Genetic | polymorphism analysis |
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| protein expression analysis | Genetic | protein expression analysis |
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| proteomic profiling | Genetic | proteomic profiling |
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| gas chromatography | Other | gas chromatography |
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| laboratory biomarker analysis | Other | laboratory biomarker analysis |
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| liquid chromatography | Other | liquid chromatography |
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| mass spectrometry | Other | mass spectrometry |
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| questionnaire administration | Other | questionnaire administration |
|
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D011230 | Precancerous Conditions |
| D003110 | Colonic Neoplasms |
| D012004 | Rectal Neoplasms |
| D018256 | Adenomatous Polyps |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D020869 | Gene Expression Profiling |
| D016133 | Polymerase Chain Reaction |
| D054458 | Amplified Fragment Length Polymorphism Analysis |
| D002849 | Chromatography, Gas |
| D002853 | Chromatography, Liquid |
| D013058 | Mass Spectrometry |
| ID | Term |
|---|---|
| D005821 | Genetic Techniques |
| D008919 | Investigative Techniques |
| D021141 | Nucleic Acid Amplification Techniques |
| D016172 | DNA Fingerprinting |
| D002845 | Chromatography |
| D002623 | Chemistry Techniques, Analytical |
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