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Colon Cancer clinical trials

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NCT ID: NCT02746432 Not yet recruiting - Colon Cancer Clinical Trials

Insulin Therapy Reduce Post-Operative Inflammatory Response After Curative Colorectal Cancer Resection: Randomization Controlled Trial

Start date: January 1, 2018
Phase: Phase 4
Study type: Interventional

Research Problem: Surgical stress induces inflammation and postoperative immuno-suppression, which are risk. factors for both post-operative complication and possible disease recurrence. Colorectal cancer is in the top 5 malignancies in the Kingdome and the highest incidence in males. Recurrent disease locally or distally occurs in 35% of patients and is the leading cause of death in these patients. Despite the new era of laparoscopic surgery, still surgical stress is present and equally traumatic to the conventional open colorectal resection, earlier studies showed no major differences in post-operative inflammatory and immunological reactions. The previous studies revealed the anti-inflammatory effects of the hyper-insulinimic euglycemic therapy. Benefits observed in both major liver resection and in cardiac surgery. The anti-inflammatory effect reduced the surgical stress and postoperative inflammation. The hypothesis is "Can intraoperative hyper-insulinimic euglycemic infusion reduce post operative inflammation and immunomodulation in colon cancer patients undergoing a curative surgery?" Research methodology Triple blinded randomized controlled study with estimated sample size of 144 patients of non-metastatic colorectal cancer patients operated at King Saud University Medical city with a confirmed diagnosis of colon adenocarcinoma. Patients Consented will undergo computer randomization to receive intraoperative hyper-insulinimic normoglycemic infusion (experimental) or standardized insulin sliding scale and saline (control). A common preoperative and postoperative pathway with standardized management and pain control in both groups. Outcomes will be measured via a battery of laboratory test consist of routine labs, inflammatory markers and immunological markers to be repeated at fixed timed intervals. All patients will be followed by regularly for 5 years. Research objectives Primary outcomes to examine: - The anti-inflammatory effects of intraoperative hyper-insulinimic euglycemic therapy in patients undergoing colorectal cancer surgery. - The immunomodulatory effect of intraoperative hyper-insulinimic euglycemic infusion Secondary outcomes: - Thirty days post-operative morbidity. - Overall survival rate. - Disease-free survival rate.

NCT ID: NCT02707796 Not yet recruiting - COLON CANCER Clinical Trials

Correlation Between Partial Oxygen Pressure and Oxygen Reserve Index

Start date: May 2016
Phase: N/A
Study type: Interventional

Oxygen reserve index (ORI) measured by multiple wave pulse co-oximeter is a new technological development in medical science. Our aim in this study is to identify the correlation between arterial oxygen pressure (PaO2) and ORI, and to identify the specificity and sensitivity of ORI as a tool to prevent hypoxia and hyperoxia in abdominal surgery patients.

NCT ID: NCT02539888 Not yet recruiting - Colon Cancer Clinical Trials

Use of Goggle Balloon to Improve Cecal Intubation During Colonoscopy

Start date: August 2017
Phase: N/A
Study type: Interventional

This is a randomized trial testing whether a device called the "goggle balloon" can improve cecal intubation in patients with known redundant colons. Because of Dr. Rex's expertise in colonoscopy, he is often referred patients who have had an attempt at colonoscopy by another physician and the physician was unable to reach the beginning of the colon because the colon was elongated or redundant. Dr. Rex has published several reports of his experience in performing colonoscopy in these patients, with a success rate of 96%. The current tools that are used for most such cases are a standard adult size colonoscope and water immersion. Water immersion refers to filling the colon with water rather than air, since water tends to distend the colon and elongate it less than air or other gas. The goggle balloon is a simple device that is passed down through the instrument channel on a catheter. Once it exits the tip of the colonoscope, it is filled with a few ml of water and pulled back on to the colonoscope tip. A cap is placed over the end of colonoscope (Olympus distal attachment) and sticks out approximately 4 mm from the end of the colonoscope. The balloon is centered by this cap. The doctor then looks at the video screen through the water-filled balloon. This device has been shown helpful in keeping the mucosa off the ends of the folds and allows the doctor to identify the luminal direction without distending the colon. It is possible that the goggle balloon would be in addition to the colonoscopy in patients with redundant colons that would further shorten the time taken to intubate the cecum and complete the colonoscopy. Both the goggle balloon and the Olympus distal attachment cap are FDA 510k cleared devices. Dr. Rex has used the distal cap on hundreds of previous colonoscopies, and performed several trials with it. Dr. Rex has also used the goggle balloon for a number of colonoscopies, and has found it easy to use and does not pose any perceivable risk to patients. Once the cecum in intubated, the goggle balloon is typically deflated and withdrawn back through the colonoscope.

NCT ID: NCT02253303 Not yet recruiting - Colon Cancer Clinical Trials

Evaluation of the Extraction-site, - Midline Incision vs Off-midline Incision-

Start date: October 2014
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the midline extraction incision in patients with colon cancer. A prospective randomized controlled trial is conducted to compare midline extraction incision with off-midline extraction incision.

NCT ID: NCT01786200 Not yet recruiting - Colon Cancer Clinical Trials

Physiological Effects of Altering Cancer-related Inflammation

Start date: February 2013
Phase: N/A
Study type: Interventional

This prospective pilot study will examine whether the previously reported effects of NSAIDs on colorectal cancer may be modulated through alterations in tissue gene expression, up regulation of local immune cell infiltrates or down-regulation of the systemic inflammatory response.

NCT ID: NCT01261962 Not yet recruiting - Colon Cancer Clinical Trials

Modulation of Immune Response by Oral Zinc Supplementation in Chemotherapy for Colon Cancer

Start date: February 2011
Phase: N/A
Study type: Interventional

In leukocytes of patients undergoing adjuvant chemotherapy for colon cancer treatment: a)identify genes modulated by oral supplementation of zinc; b) evaluate the effects of oral zinc supplementation on humoral immunity and neutrophil function. The study will be conducted on 30 adult patients aged grater than 18 years, of both genders who have undergone surgical resection of colonic neoplastic lesions without metastatic lesion. Patients will be randomized into two groups, with the first (Group QT Zn, n = 15) receive 70 mg/d of zinc for 16 weeks and the second will receive placebo (QT Placebo Group, n = 15). The study will also include 30 healthy volunteers who receive supplementation of 70 mg/d of Zn (C Zn group, n = 15) or placebo (Group C Placebo, n = 15). Zinc supplementation or placebo for all study groups will start two days before the volunteers received the pneumococcal vaccine, polyvalent 23. Fifteen days after vaccination, patients begin chemotherapy as pre-established criteria by the Oncology Service. Will be monitored the parameters of nutritional status (anthropometry, bioelectrical impedance, food intake, and laboratory tests) adverse effects, according to rules of the CTCAE. In the evaluation of humoral immunity, antibodies opsonization and in the pneumococcal polysaccharide will be measured. Will be evaluated the function of neutrophils by measuring DNA NETs and quantified calprotectin and elastase released in the culture supernatants of activated neutrophils. RT-qPCR will be done of genes differentially expressed(DEGS) on activated leukocytes. In six volunteers from each group will be analyzed global gene expression from RNA extracted from leukocytes by microarray; will be detected and correlated the molecular pathways modulated by zinc by MetaCore software (GeneGo). The DEGS will be validated by RT-qPCR.

NCT ID: NCT01214031 Not yet recruiting - Colon Cancer Clinical Trials

Prospective Study for Evaluating Colon Polyp Histology With in Vivo Probe Based Confocal Laser Endomicroscopy

Start date: September 2012
Phase: N/A
Study type: Interventional

Chromoendoscopy (that involves spraying of dyes over the colonic mucosa) combined with magnification has been utilized for polyp histology identification. Pit patterns on the surface of polyps described by Kudo et al have been shown to have a high diagnostic accuracy in differentiating the polyp types (18, 19). NBI, that is also referred to as "electronic chromoendoscopy" is another technique that has been evaluated for polyp histology identification by highlighting the superficial mucosal and vascular architecture (15, 20, 21). pCLE is another novel addition to the technologies aiming to accomplish in vivo histologic diagnosis with a high degree of accuracy. The pCLE system has three major components (Mauna Kea Technologies, Paris, France). The first is the confocal miniprobe made of approximately thirty thousand optical fibers bundled together and terminated by a distal microsystem. The images obtained have a lateral resolution of 1µm, an axial resolution of 10 µm and a maximum field of view of 240 µm. The depth of observation is from 55 to 65 µm. The miniprobe tip diameter is 2.5 mm and can be passed through the accessory channel of any standard endoscope. The second is the laser scanning unit (excitation wavelength - 488 nm) that combines the functions of laser light illumination and rapid laser scanning, enabling a frame rate up to 12 images per second and signal detection. The third is the control and acquisition software for real time image reconstruction, immediate sequences display and post-procedure analysis and editing tools. Once an area of interest (e.g. a polyp) is identified, 5 ml of 10% fluorescein sodium is injected intravenously; the confocal probe is passed through the accessory channel of the endoscope and placed against the lesion to obtain several high-quality images and video sequences. In a study by Buchner et al from the Mayo Clinic, Jacksonville, (22) this system was used to evaluate confocal images of 37 polyps from 25 patients in a blinded fashion without the knowledge of their histologic diagnosis or endoscopic appearance. The investigators developed the following criteria that were suggestive of neoplastic polyps: villiform pattern, nuclear characteristics - oval/irregular nuclear shape and increased number of nuclei. These features had a sensitivity of 82.6%, specificity of 92.9% and accuracy of 86.5% for the characterization of neoplastic polyps. Similarly, Meining et al (23) have also evaluated criteria for differentiating neoplastic from benign lesions in the colon with encouraging results. The investigators hypothesize that pCLE will have a high rate for accurate characterization of polyp histology real time during colonoscopy

NCT ID: NCT00715325 Not yet recruiting - Colon Cancer Clinical Trials

ProtectiScope CS Intended for Diagnostic and Therapeutic Colonoscopy

Start date: October 2008
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to determine whether the ProtectiScope CS is capable to perform diagnostic and therapeutic colonoscopy.

NCT ID: NCT00555295 Not yet recruiting - Colon Cancer Clinical Trials

Laparoscopic Colorectal Surgery For Cancer- Long Term Survival

Start date: December 2007
Phase: N/A
Study type: Observational

The purpose of this study is to determine the survival after laparoscopic colectomies due to carcinoma.

NCT ID: NCT00533975 Not yet recruiting - Colon Cancer Clinical Trials

A Prospective Study of a New Immunochemical Fecal Occult Blood Test in U.S. Veteran Patients Undergoing Colonoscopy

Start date: September 2007
Phase: N/A
Study type: Observational

The purpose of our study is to evaluate the diagnostic validity of a new immunofecal occult blood test (IFOBT) (Teco Diagnostics) in U.S. veterans and to compare it with the guaiac based FOBT.