Fludeoxyglucose F 18 PET Imaging in Determining Protein and Gene Expression Signatures in Patients With Premalignant Polyps or Colon Cancer

NCT00550628 | Completed

• 3 other identifiers: 07-114P30CA008748MSKCC-07114
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colorectal Cancer; Neoplasm of Uncertain Malignant Potential

Keywords

neoplasm of uncertain malignant potential; colon cancer

Outcome Measures

Primary Outcomes (1)

• Feasibility of ex-vivo imaging of colon cancer and colon polyps using fludeoxyglucose F 18 positron emission tomography (FDG PET)

  2 years

Secondary Outcomes (4)

• 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)

  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

Study Arms (1)

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.

Genetic: DNA methylation analysis; Genetic: fluorescence in situ hybridization; Genetic: gene expression analysis; Genetic: polymerase chain reaction; Genetic: protein expression analysis; Genetic: reverse transcriptase-polymerase chain reaction; Other: diagnostic laboratory biomarker analysis; Other: immunoenzyme technique; Other: immunohistochemistry staining method; Procedure: biopsy; Procedure: therapeutic conventional surgery; Radiation: fludeoxyglucose F 18

Interventions

DNA methylation analysis GENETIC

resection of a non-sarcomatous primary colon neoplasm

fluorescence in situ hybridization GENETIC

resection of a non-sarcomatous primary colon neoplasm

gene expression analysis GENETIC

resection of a non-sarcomatous primary colon neoplasm

polymerase chain reaction GENETIC

resection of a non-sarcomatous primary colon neoplasm

protein expression analysis GENETIC

resection of a non-sarcomatous primary colon neoplasm

reverse transcriptase-polymerase chain reaction GENETIC

resection of a non-sarcomatous primary colon neoplasm

diagnostic laboratory biomarker analysis OTHER

resection of a non-sarcomatous primary colon neoplasm

immunoenzyme technique OTHER

resection of a non-sarcomatous primary colon neoplasm

immunohistochemistry staining method OTHER

resection of a non-sarcomatous primary colon neoplasm

biopsy PROCEDURE

resection of a non-sarcomatous primary colon neoplasm

therapeutic conventional surgery PROCEDURE

resection of a non-sarcomatous primary colon neoplasm

fludeoxyglucose F 18 RADIATION

resection of a non-sarcomatous primary colon neoplasm

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

MSK clinic

You may qualify if:

• Patients eligible for entry into the study are those:
• Age 15 to 100
• Undergoing resection of a non-sarcomatous primary colon neoplasm who also has 2 or more adenomas each greater than or equal to 7-10mm in size which are anticipated to be removed with the colon specimen.
• It will be known from MSKCC or outside studies (barium enema, endoscopy, PET/CT, or CT colonography) that the patient has at least 2 proven adenomas 7-10 mm or greater and a primary colon neoplasm

You may not qualify if:

• Insulin-dependent diabetics (as established by routine history and presurgical laboratory tests).

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

tissue

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms

Interventions

DNA Methylation; In Situ Hybridization, Fluorescence; Gene Expression Profiling; Polymerase Chain Reaction; Reverse Transcriptase Polymerase Chain Reaction; Immunoenzyme Techniques; Immunohistochemistry; Biopsy; Fluorodeoxyglucose F18

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

Intervention Hierarchy (Ancestors)

Methylation; Alkylation; Biochemical Phenomena; Chemical Phenomena; Metabolism; Genetic Phenomena; In Situ Hybridization; Staining and Labeling; Histocytological Preparation Techniques; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Investigative Techniques; Cytogenetic Analysis; Genetic Techniques; Nucleic Acid Hybridization; Nucleic Acid Amplification Techniques; Immunoassay; Immunologic Techniques; Molecular Probe Techniques; Histocytochemistry; Cytodiagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Deoxyglucose; Deoxy Sugars; Carbohydrates

Study Officials

• Marc J. Gollub, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

• Suresh Jhanwar, PhD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 25, 2007
• First Posted: October 30, 2007
• Study Start: September 1, 2007
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: December 23, 2015

Record last verified: 2015-12

Locations

US (1)