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Colonic Neoplasms clinical trials

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NCT ID: NCT01535326 Completed - Pain Clinical Trials

Comparing Water Immersion and Water Exchange Methods During Minimally Sedated Colonoscopy

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

In minimally sedated Asian patients in a community setting the investigators showed that a limited volume of water infusion instead of air insufflation in either the rectal sigmoid colon or the whole colon significantly reduced pain score during colonoscopy. Cecal intubation rate was not compromised. The reduction of pain score ranges from 25% to 32 % in our previous studies.1, 2 In contrast, several US reports described the successful use larger volumes of water infused throughout the entire colon in patients undergoing colonoscopy which result in a greater reduction of the pain score, averaging about 56%.3-5 A recent review suggested that the cause of the difference might lies in the timing of water removal.6 Specifically, the investigators group removed the infused water predominantly during withdrawal phase (water immersion) and the U.S. group removed water during insertion phase (water exchange). This prospective, randomized controlled trial compared water exchange or water immersion with traditional air insufflation in patients undergoing minimally sedated colonoscopy. The investigators test the hypothesis that water exchange can reduce more pain than water immersion in the investigators clinical setting.

NCT ID: NCT01528878 Completed - Colonic Neoplasms Clinical Trials

Safety, Efficacy, and Dosing of Stereotactic Radiosurgery for Hepato-cellular Carc/Colo-rectal Liver Metastases

Start date: April 2009
Phase: N/A
Study type: Interventional

The purpose of this study is to determine a tolerable dose of radiation delivered by the CyberKnife system in two groups of patients with hepatocellular carcinoma (HCC).

NCT ID: NCT01519817 Completed - Neoplasms Clinical Trials

Cancer Vaccine Targeting Brachyury Protein in Tumors

Start date: January 5, 2012
Phase: Phase 1
Study type: Interventional

Background: - Cancer vaccines are being developed to help teach the body's immune system to attack and destroy cancer cells. A new vaccine being tested targets Brachyury protein. This protein is present in some tumor cells, and it can help tumor cells spread to other parts of the body. Researchers want to see whether the new Brachyury protein vaccine can help treat people with advanced carcinomas. Objectives: - To test the safety and effectiveness of a cancer vaccine that targets Brachyury protein in tumor cells. Eligibility: - Individuals at least 18 years of age who have advanced cancers that have not responded or are no longer responding to standard treatments. - Because the vaccine is made with yeast, people with yeast allergies will not be eligible. Design: - Participants will be screened with a medical history and physical exam. Imaging studies will be used to examine the cancer. Heart and thyroid function tests will be conducted. Blood and urine samples will also be collected. - Participants will receive vaccine injections every 2 weeks, for a total of seven visits. After seven visits, if the cancer has shrunk or stopped growing, participants will continue to have the vaccine about once a month. - Treatment will be monitored with frequent blood tests and imaging studies. Other tests will be given as directed by the study doctors. Some participants will have apheresis to collect additional blood cells for study. - Participants will continue to receive the vaccine as long the tumor does not start growing again and there are no serious side effects....

NCT ID: NCT01517152 Completed - Breast Cancer Clinical Trials

Testing a Spanish Version of a Patient Toxicity Questionnaire

Start date: January 4, 2012
Phase:
Study type: Observational

Background: - The Common Terminology Criteria for Adverse Events (CTCAE) is a list of toxicities and side effects that may occur when people are having cancer treatment. Doctors and nurses use this list to describe the side effects patients experience from cancer treatment. We have developed a questionnaire to ask people having cancer treatment directly about common symptoms and side effects and to supply this information to their doctors and nurses. This questionnaire is known as PRO-CTCAE and is completed by a patient. - PRO-CTCAE was originally developed in English. Researchers want to develop a Spanish version of the patient questionnaire. To test whether the questions are well understood and whether it is easy to complete the questionnaire, the researchers will interview individuals whose primary language is Spanish and who are being treated for different types of cancer. Objectives: - To test a Spanish version of the PRO-CTCAE questionnaire. Eligibility: - Latinos at least 18 years of age who are having or have recently finished cancer treatments and whose main language is Spanish Design: - Participants will complete a questionnaire in Spanish with selected questions from the translated PRO-CTCAE. They will discuss their answers and any difficulties they might have had in understanding or answer the questions with an interviewer, who will take notes and record comments and suggestions. - Literacy is not required for this study. Participants may opt to have the questions read aloud to them by an interviewer.

NCT ID: NCT01511653 Completed - Rectal Cancer Clinical Trials

Validation of Colon Biomarkers for the Early Detection of Colorectal Adenocarcinoma

GLNE010
Start date: October 2011
Phase:
Study type: Observational

The investigators are undertaking a multi-center, 13000 subject validation study of several biomarkers for early detection of colon cancer. There are stool based biomarkers and blood based biomarkers being validated in this study. The biomarkers will be compared with colonoscopy and with FIT (fecal immunohistochemistry) tests which are the current standards for colon cancer screening. This is an NCI-early Detection Research Network funded project. The population targeted for this study are those persons undergoing colonoscopy for screening. Prior to colonoscopy or even prepping for colonoscopy, subjects will provide blood and stool samples as well as specific data regarding their GI and general medical history and concomitant medications. If subjects are interested in participating, arrangements will be made to see them. The informed consent process will take place, blood will be obtained, data will be obtained, and the stool kit described and given to the subject to take home. Stool samples will be sent back to the University of Michigan using prepaid mailing labels.

NCT ID: NCT01490996 Completed - Metastasis Clinical Trials

Combining Curcumin With FOLFOX Chemotherapy in Patients With Inoperable Colorectal Cancer

CUFOX
Start date: February 2012
Phase: Phase 1/Phase 2
Study type: Interventional

Oral curcumin (complex C3, Sabinsa Corp, Utah) will be given to patients with inoperable colorectal metastases who will be commencing standard care oxaliplatin-based (FOLFOX) chemotherapy for up to 12 cycles(approximately 6 months) of treatment. Primary measurements focus on safety and tolerability. These will be recorded in real-time and report the number and severity of adverse events. Secondary measurements will include efficacy, (measured by response rate with RECIST and overall survival in months) supported by biomarker analysis.

NCT ID: NCT01479894 Completed - Colon Cancer Clinical Trials

Genetic Analysis to Evaluate the Racial Difference in the Outcome of Patients With Colon Cancer

Start date: November 2011
Phase:
Study type: Observational

This is a retrospective genetic analysis of stored tumor tissue samples to evaluate the distribution of Recurrence Score® and gene groups of stage II colon cancer in African American (AA) and Caucasian individuals. Other covariant factors in the medical chart will be analyzed as well. Three institutions will contribute patients to this study with a total patient number goal of approximately 200 with approximately 100 being AA and approximately 100 being Caucasian. As enrollment in this study proceeds a Caucasian subject will be matched for every African American enrolled.

NCT ID: NCT01477814 Completed - Colorectal Cancer Clinical Trials

Interventions to Improve Colon Cancer Screening in Poor Rural Iowa Counties

Start date: July 2008
Phase: N/A
Study type: Interventional

The goal of the study is to conduct a randomized clinical trial to test several office-based strategies for improving colon cancer screening among individuals who are regular patients at 16 family practice physician offices in the state of Iowa. These offices are members of the Iowa Research Network (IRENE), a rural practice-based research network. The interventions to be tested are increasing in intensity from the usual care provided in the office, to physician chart reminders, mailed educational materials to patients, a fecal immunochemical test with postage-paid return envelope, and a telephone call designed to determine attitudes and barriers to screening, and to motivate subjects to get screened. Our main research questions are: 1)do attitudes toward CRC screening change after providing educational materials about CRC screening? 2)do mailed educational materials and a FIT, with or without a telephone reminder, result in increased rates of CRC testing with the FIT?

NCT ID: NCT01458509 Completed - Rectal Cancer Clinical Trials

Feasibility and Psychometric Properties of Paper vs. Web vs. Automated Telephone Administration of Patient Reported Outcome Surveys

Start date: October 11, 2011
Phase:
Study type: Observational

It can be difficult to obtain the perspective of patients who have had bowel surgery. This study is being done because the investigators are trying to find out whether patient-reported outcomes, (results reported to investigators by the patient), on a regular basis, will help the investigators provide better patient care and symptom management. Therefore, the purpose of this study is to determine if it is possible and if it is useful to their medical care for patients who have had bowel surgery to complete surveys about their symptoms on a regular basis. In this study the surveys are completed from home, by web or by telephone, every month for 6 months. The results of this study will guide the design of large research studies on cancer-related bowel function. The purpose of this study is to develop a bowel function questionnaire for patients with colorectal cancer. The questionnaire will be used in future clinical trials to assess bowel function.

NCT ID: NCT01438645 Completed - Diarrhea Clinical Trials

ScopeGuide-assisted Colonoscopy Versus Conventional Colonoscopy

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

Colonoscopy is an established technology that enables doctors to obtain live video from inside patients' large intestines, which is essential for the diagnosis of numerous intestinal illnesses. It consists of a long, flexible tube fitted with a light-source and small video camera that transmits the images onto a display monitor. The doctor inserts the scope into the anus, moves it into the rectum and then guides it slowly through the entire colon. Because of the various twists and turns that are part of normal bowel anatomy, advancing the scope through the entire colon is not always successful and can become challenging when the scope forms loops inside the abdomen. Unfortunately, there is no way for the doctor to see the shape of the scope inside the body other than what is seen from the video at its front end, and so navigating the colon relies on instinct accumulated with experience and the "feel" of the scope as loops begin to form. This is important because not only can this loop formation cause pain, but it can also increase the likelihood of an incomplete test. Incomplete tests matter because a major reason for performing colonoscopy is colon cancer screening and surveillance; detecting early cancers at treatable stages and looking for polyps that may be pre-cancerous growths. When colonoscopy does not advance through the entire colon, parts are left unexamined where cancer may develop. A new technology called "ScopeGuide" has been developed that uses magnetic coils embedded within the scope to create a 3D image of the shape of the entire scope inside the body that is projected onto the monitor for the doctor to see. This will show if loops are forming and will provide information about how to eliminate loops once they have formed. In this research study, the investigators will compare colonoscopy with the assistance of ScopeGuide to colonoscopy performed in the standard fashion, to see if ScopeGuide results in more successful procedures that are easier for the doctor and more comfortable for patients.