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Colorectal Neoplasms clinical trials

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NCT ID: NCT02942901 Completed - Clinical trials for Metastatic Colorectal Cancer

Clinical Evaluation of PET-CT for Staging of Colorectal Lung Metastases

Start date: January 2015
Phase:
Study type: Observational

Surgery has been available for the treatment of pulmonary metastases in metastatic colorectal cancer and promising overall survival was observed in retrospective studies with selected patients. This study investigated whether the preoperative FDG- PET/CT scan influences survival in this patient group. Furthermore, we tried to identify other prognostic factors associated with overall survival and progression-free survival.

NCT ID: NCT02933307 Completed - Hypertension Clinical Trials

Continuous Monitoring on the General Ward

Start date: April 2015
Phase: N/A
Study type: Interventional

Rationale: Monitoring patients' vital signs is done to detect clinical deterioration. For this, the MEWS, a scoring list comprising seven vital signs measured by nursing staff, is used. Although the MEWS provides relevant data on patients' health status, the interval measurements may not capture early deterioration of vital signs, especially during the night. As a result, unsafe situations may occur such as periods of low oxygen saturation and cardiac arrhythmias, which are known to complicate postoperative course. Besides, this way of measuring vital signs may be stressful for patients and disturbs patients' sleep. New technology such as ViSi Mobile and HealthPatch allows for remote continuous monitoring of vital signs using wearable devices transmitting relevant data to nurses and clinicians. With this, the investigators think that clinical deterioration may be detected in an early phase and reduce nurse work load and patient distress. Objective: to investigate the feasibility of wearable devices on the general ward. Study design: feasibility study. Study population: adult patients hospitalized on the internal medicine ward and adult postoperative patients on the surgical ward. Intervention: patients in the intervention groups will be randomized in one of the two groups. Patients in the group 1 will wear ViSi Mobile; patients in group 2 will wear the HealthPatch. Wearable devices will be worn for at least three days. Regular MEWS measurements take place at usual time points. Main study parameters/endpoints: Evaluation with patient and care givers (primary outcome measure), MEWS calculations, time between alarm (continuous data) and next regular MEWS measurement (nurse), intervention by nurse after alarm, admission to ICU, complications, side effects of devices, STAI scores, and PCS scores will be documented. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients will wear one device for at least three days. Devices can be uncomfortable by being heavy or the patches can start itching. More measurements by nurses can take place when indicated, for example after alarms. The participating patients will fill out the STAI on daily basis and the PCS on the last day of hospitalization. Both questionnaires will take a few minutes to complete. Patients could benefit from early detection of clinical deterioration and early corrective interventions or ICU admissions.

NCT ID: NCT02931825 Completed - Cancer Colorectal Clinical Trials

Identification of High Risk People for Colorectal Cancer and Evaluation of a Specific Surveillance System

ISIRECC
Start date: May 23, 2017
Phase: N/A
Study type: Interventional

Colorectal cancer is one the most frequent cancer in developed countries. In France, it rank third with 43000 new cases in 2015. French Health Authority recommended colonoscopy screening for people with a high risk for colorectal cancer. But this compliance with colonoscopy is low (20-40%), it is therefore necessary to develop new strategies to improve compliance. The purpose of this project is to to offer and evaluate the feasibility and the effectiveness of a specific surveillance system for high risk people for colorectal cancer The project will be divided into 2 phases: Objectives of the first phase: - Identify high risk people for colorectal cancer in the department of Indre-et-Loire, - Fill in as completely as possible their colonoscopic history in the past 5 years, - Estimate the proportion of high risk people for colorectal cancer in the target population for colorectal cancer screening in Indre-et-Loire (Men and women aged from 50 to 74 years). Objective of the second phase: Compare the performed colonoscopy rate of high risk people for colorectal cancer without notion of colonoscopy in the past 58 months following or not (control group) the sending of a letter reminding the importance of compliance with colonoscopy.

NCT ID: NCT02928224 Completed - Clinical trials for BRAF V600E-mutant Metastatic Colorectal Cancer

Study of Encorafenib + Cetuximab Plus or Minus Binimetinib vs. Irinotecan/Cetuximab or Infusional 5-Fluorouracil (5-FU)/Folinic Acid (FA)/Irinotecan (FOLFIRI)/Cetuximab With a Safety Lead-in of Encorafenib + Binimetinib + Cetuximab in Patients With BRAF V600E-mutant Metastatic Colorectal Cancer

BEACON CRC
Start date: October 13, 2016
Phase: Phase 3
Study type: Interventional

This is a multicenter, randomized, open-label, 3-arm Phase 3 study to evaluate encorafenib + cetuximab plus or minus binimetinib versus Investigator's choice of either irinotecan/cetuximab or FOLFIRI/cetuximab, as controls, in patients with BRAFV600E mCRC whose disease has progressed after 1 or 2 prior regimens in the metastatic setting. The study contains a Safety Lead-in Phase in which the safety and tolerability of encorafenib + binimetinib + cetuximab will be assessed prior to the Phase 3 portion of the study.

NCT ID: NCT02909478 Completed - Colorectal Cancer Clinical Trials

Aprepitant Without Steroid in Preventing Chemotherapy-induced Nausea and Vomiting in Patients With Colorectal Cancer

Start date: September 1, 2017
Phase: Phase 3
Study type: Interventional

Addition of aprepitant, an NK1 receptor antagonist to a 5-HT3 receptor antagonist and dexamethasone regimen was shown to be effective for prevention of chemotherapy-induced nausea and vomiting (CINV) with moderately emetogenic chemotherapy (MEC). Little is known about the efficacy of aprepitant when used without dexamethasone. Dexamethasone is widely used to prevent both acute and delayed nausea and vomiting induced by chemotherapy. However, multi-period use of dexamethasone could be associated with side effect, such as hyperglycemia, dyspepsia and insomnia. This randomized phase III trial studies antiemetic therapy with aprepitant and tropisetron to see how well they work compared to dexamethasone plus tropisetron in preventing chemotherapy-induced nausea and vomiting in patients with colorectal cancer receiving FOLFOX(oxaliplatin, leuvovorin and 5-fluorouracil) chemotherapy.

NCT ID: NCT02907086 Completed - Clinical trials for Colorectal Cancer and Melanoma

Circulating Tumor Material in Colorectal Cancer and Melanoma

Start date: July 7, 2017
Phase:
Study type: Observational

Observational study to allow the collection of blood and medical information to evaluate the role of circulating tumor material in patients with colorectal cancer and melanoma

NCT ID: NCT02906059 Completed - Clinical trials for Metastatic Colorectal Cancer

Study of Irinotecan and AZD1775, a Selective Wee 1 Inhibitor, in RAS or BRAF Mutated, Second-line Metastatic Colorectal Cancer

Start date: September 2016
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine whether combination therapy of irinotecan with AZD1775 is safe and effective in treating mutated metastatic colorectal cancer patients.

NCT ID: NCT02901600 Completed - Colorectal Cancer Clinical Trials

Expression of DMBT1 in Colorectal Cancer Patients

DMBT1
Start date: June 2013
Phase: N/A
Study type: Observational

Although colorectal cancer is a preventable and curable disease if early stage tumors are removed, it is still the fourth cause of cancer worldwide and the second leading cause of death in many industrialized countries. The 5-year survival is about 55% often due to a late detection. Then, the identification of sensitive and specific molecular markers is therefore a major challenge for early diagnosis and prognosis of this disease. Preliminary work have reported variations in the expression of DMBT1 (deleted in malignant brain tumor 1), a glycoprotein co-secreted with mucins in the light of the glands, during several stages of colon carcinogenesis. The goal of this study is to study by mass spectrometry (MS), alterations in the repertoire of glycosylation of mucins from colorectal tumors of various stages, grades, and recurrence status.

NCT ID: NCT02900664 Completed - Clinical trials for Colorectal Cancer, Triple Negative Breast Cancer, NSCLC - Adenocarcinoma

A Study of PDR001 in Combination With CJM112, EGF816, Ilaris® (Canakinumab) or Mekinist® (Trametinib)

Start date: August 23, 2016
Phase: Phase 1
Study type: Interventional

The purpose of this study was to combine the PDR001 checkpoint inhibitor with each of four agents with immunomodulatory activity to identify the doses and schedule for combination therapy and to preliminarily assess the safety, tolerability, pharmacological and clinical activity of these combinations.

NCT ID: NCT02895464 Completed - Colorectal Cancer Clinical Trials

Feasibility of Home-based Preoperative Exercise in Older People

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

The purpose of the study is to evaluate the feasibility of recruitment procedure, intervention including compliance and the collaboration between in- and out patient clinics of preoperative home-based exercise in older people before colorectal surgery.