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Colon Cancer clinical trials

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NCT ID: NCT01969292 Terminated - Colon Cancer Clinical Trials

Colometer - A Real Time Quality Improvement Feedback System for Screening Colonoscopy

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

Our team has created an automated, real-time software based image analysis tool called Colometer to improve screening colonoscopy providing real time visual feedback on image quality. There are three components to this study. The first is to validate the bowel assessment preparation using the recorded colonoscopy videos from 50 consented normal risk patients. In the second phase, technological and machine user interface refinements will be identified and completed. Finally, the third phase will be a sham controlled prospective study of Colometer versus standard care in 100 consented average risk patients undergoing screening colonoscopy as performed by 10 consented endoscopists.

NCT ID: NCT01940237 Terminated - Depression Clinical Trials

A Pilot Trial of Interpersonal Psychotherapy for the Treatment of Depression in Patients With Prostate, Colorectal, Lung and Pancreatic Cancer

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

There is now overwhelming evidence documenting the efficacy of psychotherapy in the treatment of depression in the general population. Surprisingly, however, given the high prevalence of depression in cancer patients, there are very few studies on the efficacy of psychotherapy in this population. Published studies of psychotherapy in cancer patients generally include patients with high heterogeneity of psychiatric diagnosis and frequently include patients without a psychiatric diagnosis, with the aim of preventing the appearance of a psychiatric disorder. This heterogeneity complicates the interpretation of the efficacy and specificity of these interventions. Specifically, the efficacy of psychotherapy for major depression in patients with cancer is unknown.

NCT ID: NCT01882660 Terminated - Colon Cancer Clinical Trials

Pre-operative Decitabine in Colon Cancer: a Proof of Principle Study

DECO
Start date: July 2013
Phase: N/A
Study type: Interventional

Background of the study: Colon cancer is the second leading cause of cancer-related death world wide. Although patients presenting with early disease (stage I-III) can be cured, prognosis varies from 90% in stage I to 50-80% in stage II and III. Therefore, prevention of metastases after early disease is of utmost importance. Derepression of Wnt targets may provide a novel target for therapy. Objectives: The primary objective of the study is to assess in patients with primary colon cancer whether short-course pre-operative treatment with decitabine can increase Wnt target gene expression as measured in resected tumors compared to pretreatment biopsies. The secondary objective of the study is to assess in patients with primary colon cancer whether short-course pre-operative treatment with decitabine can revert CpG methylation and induce more favorable tumor characteristics as measured in resected tumors compared to pretreatment biopsies. The tertiary objective is to compare changes in Wnt target gene expression, CpG methylation and tumor characteristics for Wnt methylated and nonmethylated tumors as measured in resected tumors compared to pretreatment biopsies and identify new stratification markers.

NCT ID: NCT01855607 Terminated - Breast Cancer Clinical Trials

Topical Menthol for the Treatment of Chemotherapy Induced Peripheral Neuropathy

Start date: August 2013
Phase: Phase 2
Study type: Interventional

Primary Objective: To assess whether six-week treatment with twice daily topical Menthol application will decrease neuropathic pain as measured by the change in Brief Pain Inventory-Short Form (BPI-SF worst pain score), following or during neoadjuvant/adjuvant chemotherapy with taxane or platinum-based regimens among breast, gastrointestinal or gynecologic cancer patients. Secondary objectives: - To compare change in patient-reported outcomes: overall BPI-SF scales, EORTC-CIPN20, European Organization for Research and Treatment of Cancer Chemotherapy Quality of Life Questionnaire (EORTC QLQ-C30), Patient-Reported Outcomes Measurement Information System (PROMIS-29) scores between study groups. - To compare changes in dose delivery and early treatment discontinuation rates between study groups. - To compare objective sensory and motor functional change from baseline with the use of quantitative neurosensory testing. - To perform an exploratory analysis evaluating the interaction between treatment and chemotherapy type.

NCT ID: NCT01605318 Terminated - Rectal Cancer Clinical Trials

Study of Labetuzumab Govitecan in Participants With Metastatic Colorectal Cancer

Start date: February 12, 2013
Phase: Phase 1/Phase 2
Study type: Interventional

The goal of this clinical study is to determine the dosing and safety of labetuzumab govitecan (formerly known as IMMU-130; hMN-14-SN38, antibody-drug conjugate) in participants with colorectal cancer.

NCT ID: NCT01557881 Terminated - Lung Cancer Clinical Trials

Positron Emission Tomography/Magnetic Resonance Imaging in Patients

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

This clinical trial studies positron emission tomography (PET)/magnetic resonance imaging (MRI) in patients undergoing PET/computed tomography (CT). Diagnostic procedures, such as PET/MRI, may help doctors diagnose cancer or help doctors predict a patient's response to treatment

NCT ID: NCT01505166 Terminated - Colon Cancer Clinical Trials

Randomized Phase II Adjuvant Chemotherapy ± FANG™ in Colorectal Carcinoma With Liver Metastases

FANG-CLM
Start date: March 2012
Phase: Phase 2
Study type: Interventional

Preliminary studies with a variety of vaccines suggest target accessibility (potential immunogenicity) in a variety of solid tumors to immune directed approaches. In an effort to overcome limitations of immunostimulatory cancer vaccines, Gradalis has designed a novel autologous vaccine to address inability to fully identify cancer associated antigens, antigen recognition by the immune system (i.e. antigen-->immunogen), effector potency, and cancer-induced resistance. In an effort to overcome limitations of immunostimulatory cancer vaccines, we designed a novel dual-modulatory autologous whole cell vaccine, Vigil™, incorporating the rhGMCSF transgene and the bifunctional shRNAfurin (to block proprotein conversion to active TGFb1 and b2) to 1) address the inability to fully identify cancer associated antigens, 2) effect antigen recognition by the immune system, 3) enhance effector potency, and 4) subvert endogenous cancer-induced immune resistance. We have also completed the Phase I assessment of Vigil™ vaccine in 30 advanced solid tumor patients (1.0 x 10^7 cells/injection/month for a maximum of 12 vaccinations) who have not experienced any significant adverse effects following 144 vaccinations, including 6 patients with colorectal carcinoma. Plasmid functionality, immune biomarker response, and preliminary evidence of anticancer activity have been observed. This is a two-part Phase II study of the Vigil™ autologous vaccine. Six patients will be enrolled into the Part 1 of the study to receive intradermal autologous Vigil™ cancer vaccine (1.0 x 10^7 cells/injection; maximum of 12 vaccinations). Part 2 of the study will be a randomized Phase II study of sandwich or adjuvant chemotherapy and intradermal autologous Vigil™ cancer vaccine (1.0 x 10^7 cells/injection; maximum of 12 vaccinations) versus sandwich or adjuvant chemotherapy and placebo in patients with colorectal carcinoma with either synchronous or metachronous liver metastases (CLM +/= pulmonary metastases) following resection +/= ablation with curative intent.Sandwich therapy indicates a combination of both pre-operative and postoperative chemotherapy as opposed to neo-adjuvant (all chemotherapy prior to surgery) or adjuvant (all chemotherapy following surgery) therapy. A minimum harvest aliquot to produce 4 monthly injections will be required for entry into the study. Patients in whom insufficient tissue (<4 doses) is collected or whose vaccine fails manufacturing release criteria will not receive vaccine.

NCT ID: NCT01445054 Terminated - Breast Cancer Clinical Trials

111 Indium CHX-A DTPA Trastuzumab (Indium-Herceptin) for Imaging Breast Cancer

Start date: March 1, 2007
Phase: Early Phase 1
Study type: Interventional

Background: - Some breast cancer cells have specific proteins (receptors) on their surface that make the tumor grow faster than normal cells. One of these receptors is called HER2/neu. - An FDA-approved drug called Herceptin attaches to HER2/neu if it is present on the cancer cell. - Indium-Herceptin is an agent in which a tiny amount of radioactivity called Indium has been attached to a tiny amount of Herceptin. Objectives: -To see if Indium-Herceptin provides information about the characteristics of the breast cancer in women whose tumors express HER2/neu and those whose tumors do not. Eligibility: -Women 18 years or older with primary or metastatic breast cancer who have not received treatment with herceptin for at least 6 months before enrollment into the study. Design: - Tissue from the patient s original breast or tumor biopsy is analyzed for HER2/neu status. - Patients have a physical examination and review of medical records. - Patients receive an injection of Indium-Herceptin, followed by scanning with a gamma camera that detects the radioactivity in the Indium-Herceptin. - Patients return to the clinic 1, 2, 3 and 7 days later for repeat imaging to determine the best time to image after injection of Indium-Herceptin. - Blood samples are obtained every day of scanning to monitor the effects, if any, of the Indium-Herceptin and to see how fast the agent leaves the body.

NCT ID: NCT01440127 Terminated - Colon Cancer Clinical Trials

Impact of Pretreatment With Metformin on Colorectal Cancer Stem Cells (CCSC) and Related Pharmacodynamic Markers

Start date: August 2011
Phase: Phase 1
Study type: Interventional

Metformin is drug that is normally used to treat people with diabetes. New research has discovered that metformin may also kill cancer stem cells. These cancer stem cells make up only a small portion of a cancer, but may be responsible for resistance to chemotherapy or for causing recurrence of the cancer. The purpose of this study is to determine the effect of metformin on colorectal cancer tumors. The study is designed to develop the methods to test tumors for cancer stem cells and then to determine the difference between treating with metformin and not treating with metformin with regard to the cancer stem cells. This research is investigational because the effect of metformin on cancer stem cells is not known in humans. Also, in patients who are not diabetic, metformin would normally not be given prior to surgery.

NCT ID: NCT01347645 Terminated - Rectal Cancer Clinical Trials

Irinotecan Plus E7820 Versus FOLFIRI in Second-Line Therapy in Patients With Locally Advanced or Metastatic Colon or Rectal Cancer

Start date: September 30, 2011
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of the Phase Ib portion is to find out the highest dose of study drug that can safely be given when tested in a small group of subjects. The purpose of the Phase II portion is to find out how safe the study drug is when taken at the highest dose in a larger group of subjects.