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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA008748 | U.S. NIH Grant/Contract | View source | |
| MSKCC-07114 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
RATIONALE: Diagnostic imaging procedures, such as fludeoxyglucose F 18 PET, may be effective in detecting cancer or recurrence of cancer, or premalignant polyps.
PURPOSE: This clinical trial is studying fludeoxyglucose F 18-PET imaging to see how well it works in determining protein and gene expression signatures in patients with premalignant polyps or colon cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: Part I: Patients receive fludeoxyglucose F 18 (FDG) IV followed 45-60 minutes later by surgery to remove part or all of the colon. Tissue samples of the colon undergo positron emission tomography (PET) imaging.
Part II: Tissue samples are analyzed for glucose transporters proteins (Glut-1, 2, 3, 4, 5, 7) via IHC; presence of K-ras mutation (invariable mutant site on codon 12, 13) via PCR; 18q deletion via fluorescence in situ hybridization (FISH) or DCC IHC; MCT-1, Hex-1, Hex-2, and COX-2 expression levels via quantitative RT-PCR method or western blot; APC mutation via PCR- In Vitro Synthesized-Protein Assay or RT-PCR direct sequencing method; p53 mutation detection via immunochemistry, RT-PCR direct sequence methods, and western blot; methylation alteration of MGMT, CDKN2A, HLTF, MLH1, TIMP3, HIF1, BNIP3, and HRK via methylation detecting microchip; and specific gene methylations via methylation-specific PCR. Some tissue samples may be saved and banked for future studies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| resection of a non-sarcomatous primary colon neoplasm | The surgically removed colon will undergo ex-vivo imaging after examination in pathology. A PET scanner will be used to acquire a scan of the whole specimen. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DNA methylation analysis | Genetic |
| ||
| fluorescence in situ hybridization |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of ex-vivo imaging of colon cancer and colon polyps using fludeoxyglucose F 18 positron emission tomography (FDG PET) | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Differences in molecular and genetic profiles between FDG-positive polyps and FDG-negative polyps to suggest what gene mutations and abnormal mRNA and/or protein expressions may be required for FDG avidity ("signature" for FDG avidity) | 2 years | |
| Differences in molecular and genetic profiles between FDG-positive polyps and FDG-positive cancers to suggest what gene mutations and abnormal mRNA and/or protein expressions may be required for cancer formation ("signature" for cancer) |
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Subject Inclusion Criteria:
Subject Exclusion Criteria:
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MSK clinic
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| Name | Affiliation | Role |
|---|---|---|
| Marc J. Gollub, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Suresh Jhanwar, PhD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10065 | United States |
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tissue
| Genetic |
|
| gene expression analysis | Genetic |
|
| polymerase chain reaction | Genetic |
|
| protein expression analysis | Genetic |
|
| reverse transcriptase-polymerase chain reaction | Genetic |
|
| diagnostic laboratory biomarker analysis | Other |
|
| immunoenzyme technique | Other |
|
| immunohistochemistry staining method | Other |
|
| biopsy | Procedure |
|
| therapeutic conventional surgery | Procedure |
|
| fludeoxyglucose F 18 | Radiation |
|
| 2 years |
| Differences in molecular and genetic profiles between normal colonic mucosa, polyps, and cancer | 2 years |
| Differences and similarities in molecular and genetic profiles between FDG-positive cancers and polyps | 2 years |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D003110 | Colonic Neoplasms |
| 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 |
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| ID | Term |
|---|---|
| D019175 | DNA Methylation |
| D017404 | In Situ Hybridization, Fluorescence |
| D020869 | Gene Expression Profiling |
| D016133 | Polymerase Chain Reaction |
| D020133 | Reverse Transcriptase Polymerase Chain Reaction |
| D007124 | Immunoenzyme Techniques |
| D007150 | Immunohistochemistry |
| D001706 | Biopsy |
| D019788 | Fluorodeoxyglucose F18 |
| ID | Term |
|---|---|
| D008745 | Methylation |
| D000478 | Alkylation |
| D001669 | Biochemical Phenomena |
| D055598 | Chemical Phenomena |
| D008660 | Metabolism |
| D055614 | Genetic Phenomena |
| D017403 | In Situ Hybridization |
| D013194 | Staining and Labeling |
| D016591 | Histocytological Preparation Techniques |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006652 | Histological Techniques |
| D008919 | Investigative Techniques |
| D020732 | Cytogenetic Analysis |
| D005821 | Genetic Techniques |
| D009693 | Nucleic Acid Hybridization |
| D021141 | Nucleic Acid Amplification Techniques |
| D007118 | Immunoassay |
| D007158 | Immunologic Techniques |
| D015336 | Molecular Probe Techniques |
| D006651 | Histocytochemistry |
| D003581 | Cytodiagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D003847 | Deoxyglucose |
| D003837 | Deoxy Sugars |
| D002241 | Carbohydrates |
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