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Recurrence clinical trials

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NCT ID: NCT00903565 Active, not recruiting - Colon Cancer Clinical Trials

A Prospective Study for the Assessment of Recurrence Risk in Stage II Colon Cancer Patients Using ColoPrint

PARSC
Start date: September 2008
Phase:
Study type: Observational

The aim of this study is to enroll 785 eligible stage II colon cancer patients in order to validate the performance of ColoPrint in estimating 3-year relapse rate. Secondary objectives include comparing the objective risk assessment results from the prognostic profile (ColoPrint) to both the risk assessment based on the ASCO criteria, as well as the Investigator's independent assessment. As this is the first prospective study of ColoPrint, this study will also address the logistics and quality assurance of using ColoPrint in clinical practice. Patient treatment is at the discretion of the physician, adhering to National Comprehensive Cancer Network (NCCN)-approved regimens or a recognized alternative. The enrollment period will be 6 years. It is expected that 1800 to 2400 patients will be enrolled in order to obtain 785 analysable stage II samples from eligible patients. Approximately 25-35 clinical sites will be involved worldwide. The statistical analysis will be performed by Agendia and an independent research institute or hospital. Study Design Extension Study: This will be a prospective study to measure the impact of ColoPrint on adjuvant treatment in stage 2 colorectal cancer patients. After surgery the tumor sample will be shipped in RNA Retain to Agendia. The online Clinical Report Form (CRF) 0 will be completed to document if the patient fulfils the inclusion criteria. Baseline clinical data and the patient and physician chemotherapy intention, patient's perceived recurrence risk and decisional conflict without knowing the ColoPrint result will be entered in CRF 1. After completion of CRF1 the ColoPrint result is released. CRF2 will be completed after the final treatment decision has been made. This CRF will capture the patient and physician chemotherapy intention, patient's perceived recurrence risk and decisional conflict, impact of ColoPrint and the actual treatment the patient will receive. CRF3 will be completed 12 months after enrolment and will capture the patient status, patient's perceived recurrence risk and decisional conflict. CRF4 and 5 will be completed 3 and 5 years after surgery and will capture the patient status. A sample size of 210 stage 2 colon cancer patients is required to detect a 10% overall treatment change (5% significance and 90% power). Reporting of the Results: Blinded Study; The ColoPrint results will not be reported to the physician and/or patient at the time of enrolment. All samples will be stored in a freezer until 550-575 eligible stage II patients have been enrolled. Samples will then be analyzed in one batch in a blinded fashion from the clinical results. Extension Study; The ColoPrint results will be reported to the physician and patient after CRF1 has been completed.

NCT ID: NCT00903240 Completed - Clinical trials for Bladder Cancer Recurrence

Observational Study of Subjects Having Routine Recurrence Screening for Bladder Cancer

Start date: May 2009
Phase: N/A
Study type: Observational

The purpose of this study is to detect recurrent bladder cancer using a combination of protein and DNA biomarkers in urine

NCT ID: NCT00901797 Recruiting - Clinical trials for Recurrent Shoulder Dislocations

Arthroscopic Rotator Interval Closure in Shoulder Instability Repair

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

Study Title: Arthroscopic rotator interval closure in shoulder instability repair - a prospective study Objective: To evaluate the effect of arthroscopic rotator interval closure (ARIC) on patients with recurrent shoulder dislocations undergoing arthroscopic bankart repair (ABR) in terms of recurrence, rehabilitation and function. Hypothesis: 1. Although Hyperlax patients undergoing ABR have higher incidence of recurrent shoulder dislocations than those without hyperlaxity, adding ARIC will lower the recurrent dislocation rate. 2. Patients with arthroscopic bankart repair (ABR) and ARIC are slower in gaining the range of motion (ROM) but within 6 months are equal to those with ABR only.

NCT ID: NCT00897949 Completed - Migraine Headache Clinical Trials

MK0462 in Treatment of Migraine With Recurrence (MK0462-022)

Start date: March 1995
Phase: Phase 3
Study type: Interventional

A study to evaluate rizatriptan/MK0462 (5 and 10 mg) for the treatment of acute migraine attack and treatment of up to two headache recurrences compared to placebo. The long term extension study which pools patients from MK0462-022, -025, and -029 is described in NCT01286207.

NCT ID: NCT00897299 Completed - Breast Cancer Clinical Trials

Identifying Genes That Predict Recurrence in Women With Breast Cancer Treated With Chemotherapy

Start date: October 7, 2005
Phase: N/A
Study type: Observational

RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict whether cancer will come back after treatment. PURPOSE: This laboratory study is identifying genes that may help predict recurrence in women with breast cancer treated with chemotherapy.

NCT ID: NCT00895713 Completed - Clinical trials for Hepatitis B, Chronic

Efficacy and Safety of Intramuscular HBIG Grifols for the Prevention of Recurrence After Liver Transplantation

Start date: November 2004
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine if treatment with intramuscular hepatitis B virus immune globulin Grifols, a new specific hepatitis B immune globulin, is effective and safe for the prevention of hepatitis B virus recurrence after orthotopic liver transplantation.

NCT ID: NCT00882791 Completed - Clinical trials for Basal Cell Carcinoma

Basal Cell Carcinoma Recurrence After Mohs Surgery

Start date: May 2008
Phase:
Study type: Observational

Basal cell carcinoma (BCC) is the most common skin cancer in the US and can cause significant adverse effects. Mohs micrographic surgery, the treatment of choice for higher risk BCC, allows for removal of lesions with preservation of healthy tissue. Although the BCC recurrence rate post Mohs surgery is estimated at 1-2%, recent data is lacking to validate this historical measurement. Our purpose is to determine the current recurrence rate of BCC after Mohs surgery.

NCT ID: NCT00870649 Completed - Clinical trials for Schistosoma Haematobium

Efficacy of Bilhvax in Association With Praziquantel for Prevention of Clinical Recurrences of Schistosoma Haematobium

Bilhvax3
Start date: February 2009
Phase: Phase 3
Study type: Interventional

Objectives:To reduce the risk of S. haematobium pathology recurrences during the three years following vaccine administration and to control the safety of this therapeutic strategy in children exposed to urinary schistosomiasis. Methodology : Phase III trial, self-contained, randomized, double blind, in two parallel groups receiving 3 injections at D0, W4, W8 and a boost at W52, one group receiving "Bilhvax", the other one placebo, in S. haematobium infected children pretreated by two doses of PZQ (at W9 and W8) Patient included : Infected school children, 6 to 9 years of age. Primary objective : To demonstrate a significant delay of recurrence of the schistosomiasis pathology in vaccine group compared to control group in the 3 years period following the first administration (between D0 and W152). Secondary objective : safety Duration : February 2009 to March 2012

NCT ID: NCT00864318 Completed - Germ Cell Tumors Clinical Trials

Dose Intensification Study in Refractory Germ Cell Tumors With Relapse and Bad Prognosis

TICE
Start date: March 13, 2009
Phase: Phase 2
Study type: Interventional

Not randomized, multicentric, national phase II trial estimating the efficacy of an intensification protocol in patients with refractory germ cell tumors with relapse and bad prognosis. Treatment consists in two Paclitaxel and Ifosfamide intensification cycles followed by three Carboplatine and Etoposide high dose cycles. The point is the individual Carboplatine adjustment to take into account inter-individual patients variability. This adaptation allow to control each patient plasmatic exposition to avoid both inacceptable toxicities (such as ear toxicity) and a low exposition losing then the benefit of this high dose protocol.

NCT ID: NCT00861146 Completed - Clinical trials for Tobacco Use Cessation

Concurrent Alcohol and Smoking Treatment: Effects on Alcohol Relapse Risk

Start date: April 2009
Phase: Phase 2
Study type: Interventional

The majority of individuals with alcohol problems remain current smokers, and the negative health consequences of smoking among these individuals are substantial. This study will investigate the impact of smoking cessation interventions initiated during intensive alcohol treatment on processes reflecting risk of alcohol relapse.