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Rectal Aberrant Crypt Foci and Other Intermediate Biomarkers for Sporadic Colorectal Neoplasia: Cross-Sectional Prevalence and Modulation by Celecoxib Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on Rectal Aberrant Crypt Foci and Other Intermediate Biomarkers for Sporadic Colorectal Neoplasia: Cross-Sectional Prevalence and Modulation by Celecoxib conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Rectal Aberrant Crypt Foci and Other Intermediate Biomarkers for Sporadic Colorectal Neoplasia: Cross-Sectional Prevalence and Modulation by Celecoxib Clinical research trials and Rectal Aberrant Crypt Foci and Other Intermediate Biomarkers for Sporadic Colorectal Neoplasia: Cross-Sectional Prevalence and Modulation by Celecoxib health trials occur in hundreds of cities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Rectal Aberrant Crypt Foci and Other Intermediate Biomarkers for Sporadic Colorectal Neoplasia: Cross-Sectional Prevalence and Modulation by Celecoxib. Rectal Aberrant Crypt Foci and Other Intermediate Biomarkers for Sporadic Colorectal Neoplasia: Cross-Sectional Prevalence and Modulation by Celecoxib Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Rectal Aberrant Crypt Foci and Other Intermediate Biomarkers for Sporadic Colorectal Neoplasia: Cross-Sectional Prevalence and Modulation by Celecoxib clinical trial. Participants oftentimes recieve the most expert healthcare available for their Rectal Aberrant Crypt Foci and Other Intermediate Biomarkers for Sporadic Colorectal Neoplasia: Cross-Sectional Prevalence and Modulation by Celecoxib condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "R" Clinical Trials Conditions > Rectal Aberrant Crypt Foci and Other Intermediate Biomarkers for Sporadic Colorectal Neoplasia: Cross-Sectional Prevalence and Modulation by Celecoxib  Rectal Aberrant Crypt Foci and Other Intermediate Biomarkers for Sporadic Colorectal Neoplasia: Cross-Sectional Prevalence and Modulation by Celecoxib
Rectal Aberrant Crypt Foci and Other Intermediate Biomarkers for Sporadic Colorectal Neoplasia: Cross-Sectional Prevalence and Modulation by Celecoxib
For Condition: Adenoma,Colorectal Neoplasms
Status: Recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: Colorectal cancer is a leading cause of malignant death in the United States. Cancer chemoprevention, defined as the administration of pharmaceutical agents to modulate tumorigenesis, appears to be a promising strategy for delaying, diminishing, or eliminating colorectal neoplasia. Nonsteroidal anti-inflammatory drugs have demonstrated exciting chemopreventive activity against intestinal tumors, presumably due to their cyclooxygenase-blocking properties. A new, more selective cyclooxygenase-2 inhibitor, celecoxib, has been recently approved for clinical use. This compound has an excellent safety profile and appears to also have enhanced chemopreventive efficacy relative to traditional nonsteroidal anti-inflammatory drugs. The primary objective of this study is to investigate the effects of celecoxib on rectal aberrant crypt foci among individuals with above average-risk for developing colorectal tumors. All subjects will be prospectively recruited from among adult colonoscopy patients seen at the National Naval Medical Center. Eligible participants will include patients found to have one adenoma greater than 1 cm in diameter or three adenomas greater than or equal to 5 mm in diameter (if 18-49 years of age) or one adenoma greater than or equal to 5 mm in diameter (if greater than or equal to 50 years of age) and at least 5 rectal aberrant crypt foci. Enrolled subjects (n=40) will be randomly assigned to receive either celecoxib 400 mg by mouth twice per day or placebo. After an intervention period of six months, a follow-up endoscopic (flexible sigmoidoscopy) examination of the distal colorectum will be performed. At the baseline colonoscopy procedure, rectal aberrant crypt foci will be quantitated and ascending and descending colon normal-appearing mucosa will be biopsied to measure proliferation, apoptosis, and gene expression biomarkers. The same will occur on the samples collected during the follow-up flexible sigmoidoscopy with biopsies of normal-appearing mucosa of the descending colon. Efficacy of the chemopreventive agent will be assessed by comparing pre-versus post-intervention changes across treatment arms. Informed consent for the baseline biomarker assessments will be documented prior to the initial colonoscopy. In most cases, the presence or absence of colorectal neoplasia will not be know prior to this procedure. Thus, we plan to obtain ascending and descending,normal,colonic mucosa samples from approximately 40 subjects with no colorectal adenomas and 40 subjects with at least one adenoma. Exact sample sizes will be determined by the subject subgroup distribution at the time of full accrual into the intervention trial. Colorectal neoplasms identified during the baseline colonoscopy will additionally be sampled to allow for biomarker comparisons to be made between normal and dysplastic tissues. As designed, this study will (1) provide novel data regarding the baseline prevalence and effects of celecoxib on rectal aberrant crypt foci among patients with sporadic colorectal adenomas and (2) help to clarify the utility of rectal mucosal biomarkers for ongoing and future chemoprevention research.
Details: Colorectal cancer is a leading cause of malignant death in the United States. Cancer chemoprevention, defined as the administration of pharmaceutical agents to modulate tumorigenesis, appears to be a promising strategy for delaying, diminishing, or eliminating colorectal neoplasia. Nonsteroidal anti-inflammatory drugs have demonstrated exciting chemopreventive activity against intestinal tumors, presumably due to their cyclooxygenase-blocking properties. A new, more selective cyclooxygenase-2 inhibitor, celecoxib, has been recently approved for clinical use. This compound has an excellent safety profile and appears to also have enhanced chemopreventive efficacy relative to traditional nonsteroidal anti-inflammatory drugs. The primary objective of this study is to investigate the effects of celecoxib on rectal aberrant crypt foci among individuals with above average-risk for developing colorectal tumors. All subjects will be prospectively recruited from among adult colonoscopy patients seen at the National Naval Medical Center. Eligible participants will include patients found to have one adenoma greater than 1 cm in diameter or three adenomas greater than or equal to 5 mm in diameter (if 18-49 years of age) or one adenoma greater than or equal to 5 mm in diameter (if greater than or equal to 50 years of age) and at least 5 rectal aberrant crypt foci. Enrolled subjects (n=40) will be randomly assigned to receive either celecoxib 400 mg by mouth twice per day or placebo. After an intervention period of six months, a follow-up endoscopic (flexible sigmoidoscopy) examination of the distal colorectum will be performed. At the baseline colonoscopy procedure, rectal aberrant crypt foci will be quantitated and ascending and descending colon normal-appearing mucosa will be biopsied to measure proliferation, apoptosis, and gene expression biomarkers. The same will occur on the samples collected during the follow-up flexible sigmoidoscopy with biopsies of normal-appearing mucosa of the descending colon. Efficacy of the chemopreventive agent will be assessed by comparing pre-versus post-intervention changes across treatment arms. Informed consent for the baseline biomarker assessments will be documented prior to the initial colonoscopy. In most cases, the presence or absence of colorectal neoplasia will not be known prior to this procedure. Thus, we plan to obtain ascending and descending, normal, colonic mucosa samples from approximately 40 subjects with no colorectal adenomas and 40 subjects with at least one adenoma. Exact sample sizes will be determined by the subject subgroup distribution at the time of full accrual into the intervention trial. Colorectal neoplasms identified during the baseline colonoscopy will additionally be sampled to allow for biomarker comparisons to be made between normal and dysplastic tissues. As designed, this study will (1) provide novel data regarding the baseline prevalence and effects of celecoxib on rectal aberrant crypt foci among patients with sporadic colorectal adenomas and (2) help to clarify the utility of rectal mucosal biomarkers for ongoing and future chemoprevention research.
Eligibility:
Study Type: Interventional, Treatment, Safety/Efficacy
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: Baseline gene expression assessment: Age greater than or equal to 18 years when a medically indicated colonoscopic procedure is pending. DOD beneficiary. Signed informed consent #1. INCLUSION CRITERIA: Intervention trial: Age greater than or equal to 18 years with at least one adenoma greater than or equal to 1 cm or greater than or equal to 3 of any size and at least 5 rectal ACF's OR age greater than or equal to 50 years with at least one adenoma greater than or equal to 5 mm and at least 5 rectal ACF's. Participants greater than 50 years with a history of polyps (at lease one adenoma) within the past 5 years. All female subjects of child bearing potential must be willing to use an acceptable method of birth control (e.g.: intrauterine device, hormonal contraceptive, diaphragm and spermicide). The subject's anticipated use of oral/intravenous corticosteriods must be less than 2 weeks over a six-month period. The subject's anticipated use of orally inhaled steroid must be less than 4 weeks over a 6 month period. If nasally inhaled steroid use is anticipated, the subject should agree to use mometasone (Nasonex) only. Use of mometasone is not restricted (all other nasal steroids are prohibited). Subjects may change to mometasone, but must have discontinued the previous nasal steroid for at least 30 days prior to baseline. The subject must meet laboratory eligibility criteria within 8 weeks of the baseline colonoscopy: a) Hemoglobin greater than 11.5 gm/dl b) WBC greater than 3000/ul c) Platelet count greater than 125,000/ul d) Creatinine less than or equal to 1.5 times upper limit of normal e) AST less than or equal to 1.5 times upper limit of normal f) ALT less than or equal to 1.5 times upper limit of normal g) Total bilirubin less than or equal to 1.5 times upper limit of normal h) Alk Phos. less than or equal to 1.5 times upper limit of normal i) Pregnancy test negative Signed informed consent #2 EXCLUSION CRITERIA: Baseline biomarker assessment: History of germline cancer syndrome. Current colorectal cancer. Inflammatory bowel disease (Crohn's disease or ulcerative colitis) Active gastrointestinal ulcers Regular NSAID or aspirin use at baseline (average of 3 or more doses per week for at least three months), with the exception of low-dose aspirin (81mg QD or QOD) used for cardiovascular disease prophylaxis. History of uncontrolled hypertension History of unstable angina History of congestive heart failure Known allergic reaction to indigo carmine History of bleeding disorder History of pelvic radiation therapy Prior history of colorectal cancer Duke's C or greater or diagnosed less than 6 months ago EXCLUSION CRITERIA: Intervention trial History of hypersensitivity reaction to NSAIDs, aspirin, or sulfa drugs (as determined by subject self-report). Pregnant or lactating women. Medical contraindications to NSAID use (serum creatinine greater than or equal to 1.5 times the upper limit of normal at baseline, history of peptic ulcer disease, asthma, or severe chronic obstructive pulmonary disease). History of chronic or acute renal or hepatic disorder or a significant bleeding disorder The subject has received any investigational medication within the past 30 days or baseline colonoscopy or is scheduled to receive an investigational drug other than celecoxib during the course of the study Current use of fluconazole or lithium The subject participated in the study previously and was withdrawn. Subjects who, in the opinion of the investigator, are unable to comply with the study requirements and will be unable to complete all study procedures as required by the protocol. Subjects with a clinically significant medical condition or clinically significant abnormal laboratory value which could, in the opinion of the investigator, compromise patient safety or preclude treatment with celecoxib. Subjects who have a known allergic reaction to indigo carmine.
Total Enrollment: 100
Location and Contact Information:
National Cancer Institute (NCI) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Clinical Support Center/NCI 1-888-624-1937
Additional Information:
Study ID Numbers: 020194; 02-C-0194
Study Start Date: May 8, 2002
Record last reviewed: March 18, 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00056615
Other Colorectal Neoplasms Studies:
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2. A phase II study of cetuximab in patients who have stage IV colorectal cancer
3. Magnetic-Targeted Doxorubicin in Treating Patients with Cancer Metastatic to the Liver
4. Photodynamic therapy with talaporfin sodium (LS11) in treating patients with refractory colorectal liver metastases
5. Tezacitabine and oxaliplatin for the treatment of patients with metastatic colorectal cancer
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Rectal Aberrant Crypt Foci and Other Intermediate Biomarkers for Sporadic Colorectal Neoplasia: Cross-Sectional Prevalence and Modulation by Celecoxib
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