Neoplasms

All Conditions

Symptoms and General Pathology

Infections

Rare Diseases

Sarcoma

Disease Progression

Sarcoma, Kaposi

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Disease Attributes

Communicable Diseases

Herpesviridae Infections

Virus Diseases

DNA Virus Infections

Neoplasms, Vascular Tissue

Soft Tissue Sarcoma

Kaposi Sarcoma

Endemic Kaposi Sarcoma

Antineoplastic Agents

All Drugs and Chemicals

Pembrolizumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Pembrolizumab Route: intravenous infusion Dose regimen: 200 mg per infusion every 3 weeks Duration of treatment: 6 months (8 cycles)

Route: intravenous infusion Dose regimen: 200 mg per infusion every 3 weeks Duration of treatment: 6 months (8 cycles)

Celeste LEBBE, MD PhD

Matthieu RESCHE-RIGON, MD PhD

Celeste Lebbe, MD PhD

laetitia Da Meda

Classic and endemic Kaposi's sarcoma (KS) are lymphangio-proliferations associated with human herpes virus 8 (HHV8), which treatment is poorly codified. Chemotherapies give at best 30-60% of transient responses. While interferon responses are frequent, this drug is often poorly tolerated in elderly patients. Therefore new therapies are needed. Classic KS represents an ideal model for evaluating new drugs since patients do not receive concomitant immunosuppressive regimens nor antiviral therapies.

Pembrolizumab, an anti-PD1 monoclonal antibody has recently been shown to improve survival in several solid tumors. In KS few data are available on the role of PD1-PD-L1 axis. A significant PD-L1 expression on HHV8-associated pleural effusion lymphomas and on KS samples have been recently reported. Our experience in classical and endemic KS supports the role of this pathway with expression of PD-L1 by subpopulations of T cells but also NK cells in peripheral blood cells from these patients and expression of PD-L1 by tumor cells in KS lesions.

In this study we will evaluate the benefit and safety profile of pembrolizumab in classic and endemic KS.

Phase II Multicentric Study of Pembrolizumab in Classic or Endemic Kaposi's Sarcoma

Essai de Phase II Multicentrique évaluant le Pembrolizumab Dans le Traitement de la Maladie de Kaposi Classique ou endémique

Best Overall Response Rate (BORR) defined by the occurrence of complete response or partial response following AIDS Clinical Trials Group (ACTG) criteria recorded from the start of treatment until 6 months or the beginning of any other specific systemic therapy for KS if it occurs before 6 months

Best overall response rate according to Physical Global Assessment (PGA) score until 6 months or the beginning of any other specific systemic therapy for KS if it occurs before 6 months

Response rate on number of lesions and at best response as defined following ACTG criteria

Response rate on the size of target lesions and at best response as defined following ACTG criteria

Response rate on tumor infiltration of target lesions and at best response as defined following ACTG criteria

Response rate on lymphedema (circumference, scale of 0 (absence) to 3 (painful or oozing)) at Month 3, Month 6 and at best response as defined following ACTG criteria

Time to response defined as the time to first response recorded from the start of treatment

Assistance Publique - Hôpitaux de Paris

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Respiratory Aspiration

Central Nervous System Depressants

Platelet Aggregation Inhibitors

Anesthetics

Propofol

Sevoflurane

Anesthetics, Intravenous

Hypnotics and Sedatives

Anesthetics, General

Anesthetics, Inhalation

The sevoflurane group was maintained via sevoflurane vaporizer between 1% and 3% (target minimum alveolar concentration of 0.7-1.3).

The propofol group was both induced and maintained at an effect-site concentration (Ce) of 2.0-4.0 mcg/mL by a target-controlled infusion (TCI) system.

The sevoflurane group was maintained via sevoflurane vaporizer between 1% and 3% (target minimum alveolar concentration of 0.7-1.3 MAC)

Hung-Te Hsu, MD

Hung-Te Hsu

This is a two-arm, parallel-group randomized clinical trial. Routine perioperative care would be performed in volunteers with primary early lung cancer. The study will enroll approximately 300 volunteers to compare the progression-free or overall survival in patients undergoing video-assisted thoracoscopic surgery (VATS) for primary lung tumors between propofol and sevoflurane for the maintenance of anesthesia.

Before the scheduled procedure, the patients are randomly assigned into peopofol group or groups (1:1) according to the randomization generated by the computer. Both groups were induced with propofol 1\~2.5 mg/kg propofol. The propofol group was maintained at an effect-site concentration of 2.0-4.0 mcg/mL by a target-controlled infusion system. The sevoflurane group was maintained via sevoflurane vaporizer between 1% and 3% (target minimum alveolar concentration of 0.7-1.3 MAC). During the operation, the dose of anesthetic drugs (propofol/fentanyl /remifentanil and sevoflurane/cisatracurium/rocuronium) are adjusted to maintain the mean arterial pressure and heartbeat fluctuations within 20% of the baseline value and Entropy (or BIS) value at 40-60in both groups. The following patient data were recorded, the type of anesthesia, sex, age at the time of surgery, preoperative Karnofsky performance status score and functional capacity, the postoperative complications within 30 days (according Clavien-Dindo classification), American Society of Anesthesiologists physical status scores, tumor size, intraoperative blood loss/transfusion, duration of surgery, duration of anesthesia, total opioid (remifentanil/fentanyl/ propofol) use, postoperative radiation therapy, postoperative chemotherapy, postoperative concurrent chemoradiotherapy, the presence of disease progression, and 6-month, 1-year, and 3-year overall survival and Karnofsky performance status score were recorded.

The Effects of Using Different Anesthetics on the Prognosis of Primary Lung Tumors and Its Mechanism of Action

To Compare the Effects of Intraoperative Use of Intravenous Anesthetics Propofol and Inhaled Anesthetics Sevoflurane on the Prognosis of Patients Undergoing Surgery for Primary Lung Tumors and the Investigation of Its Mechanism of Action.

record the time the opeartion and anesthesia

6-month overall survival, 1-year overall survival, and 3-year overall survival

From the date of surgery until the date of first documented progression (recurrence or metastasis) or date of death from any cause, assessed up to 36 months

Clavien-Dindo classification, and other postoperative complications

to access patients' functional impairment

the length of stays in general ward and ICU

Kaohsiung Medical University Chung-Ho Memorial Hospital

Skin and Connective Tissue Diseases

Breast Neoplasms

Recurrence

Neoplasm Recurrence, Local

Neoplastic Processes

Patients with initially clinically negative axilla (cN0), submitted to neoadjuvant treatment, followed by surgical procedure within ALND or SLNB was done, and the final pathological report was ypN0.

Patients with initially clinically involved axilla (cN1-2), submitted to neoadjuvant treatment, followed by surgical procedure within ALND or SLNB was done, and the final pathological report was complete axillary remission (ypN0).

Patients with initially clinically negative axilla (cN0), submitted to neoadjuvant treatment, followed by surgical procedure within SLNB was done, followed by ALND because of positive pathological report of sentinel node(s).

Patients with initially clinically positive axilla (cN1-3) submitted to neoadjuvant treatment, followed by surgical procedure within ALND was done and the final pathological report was ypN1-3.

Ana C Car Peterko

From May 2016 till May 2018 all breast cancer patients with operable disease submitted to surgery after neoadjuvant treatment would be divided in four groups considering initially clinical axillary stage, axillary procedure that was done, axillary response to preoperative systemic treatment and pathological axillary stage.

In first postoperative year all patients will be monitored for appearance of locoregional and distant recurrence.

From May 2017 SLNB after neoadjuvant treatment was introduced in clinical practice for breast cancer patients presenting initially with involved axilla but shifted to clinically negative followed neoadjuvant treatment. This retrospective analysis is designed for period of one year before and one year later to compare the clinical outcomes for this patients in the setting where ALND was performed to the setting where SLNB was performed.

The main hypothesis was to establish that SLNB after neoadjuvant treatment, in initially node positive breast cancer patients that achieve complete clinical remission following neoadjuvant treatment, is reliable alternative to ALND in maintenance of locoregional control of disease.

For the purpose of this trial four groups were created and the results would be compared among them. In first postoperative year patients were monitored for the appearance of locoregional and distant recurrence.

Data were collected individually for each patient and recorded in register. All data are available to all members of investigation team, members of Ethic Committee and statistician.

Data collected in this trial would be used for publication.

SLNB After Neoadjuvant Treatment in Node Positive Patients

Impact of Sentinel Lymph Node Biopsy After Neoadjuvant Treatment on Locoregional Control of Disease in Initially Node Positive Breast Cancer Patients

To compare prolonged axillary serous secretion and arm lymphedema among patients submitted to ALND and SLNB.

All patients would be monitored in postoperative period of minimally one year for the appearance of locoregional recurrence. Results will be compared among all node negative patients (group 1 and 2) submitted to SLNB vs. ALND, and among group 2 patients only (ALND vs. SLNB).

All patients would be monitored in postoperative period of minimally one year for appearance of distant recurrence (disease progression). Results will be compared among patients from groups 2 and 4 and among group 2 patients only (ALND vs SLNB).

Clinical Hospital Center Rijeka

general surgeon

Blood and Lymph Conditions

Immune System Diseases

Lymphoma

Lymphoma, T-Cell

Lymphoma, T-Cell, Peripheral

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

Lymphosarcoma

Peripheral T-cell Lymphoma

Pralatrexate will initially be administered at a dose of 30 mg/m2/week on days 1, 8, 15, 22, 29 and 36 for 6 weeks in a 7-week cycle (cycle: 6 weeks + 1 week rest). The scheduled date can be done within a window time of plus or minus 1 day

This is a single arm study. Pralatrexate will be administered via IV over 3-5 minutes into a IV line containing normal saline (0.9% sodium chloride, NaCl) with the initial dose of 30 mg/m2/week on days 1, 8, 15, 22, 29, and 36 for 6 weeks in a 7-week cycle. The scheduled date can be done within a window time of plus or minus 1 day. The pralatrexate dose may be reduced to 20 mg/m2/week or omit if a patient experiences adverse events. Pralatrexate administration can be up to 5 cycles or until subject meets withdrawal criteria.

Pralatrexate

Bor-Sheng Ko, PhD

Brook Chung, MSc

This study is to evaluate the objective response rate to pralatrexate in Asian PTCL patients after prior treatment failure, as determined by independent imaging reviewer(s) using international workshop lymphoma response criteria (IWC)

Peripheral T-cell lymphomas (PTCL) are a group of aggressive and diverse lymphoproliferative disorders. It is characterized by the presence of malignant mature T-cells or NK cells. There is as yet no consensus regarding standard frontline or relapsed/refractory therapy for PTCL.

A previous phase II study conducted in US showed durable responses of pralatrexate treatment in relapsed or refractory PTCL, irrespective of age, histological subtypes, amount of prior therapy, prior methotrexate, and prior autologous stem-cell transplant. This single-arm, multi-center study aims to evaluate the efficacy and safety of pralatrexate monotherapy in prior treatment failure PTCL patients who may undergo HSCT in case of CR or PR, or continue pralatrexate in case of CR, PR or SD.

Primary objective:

* To evaluate the objective response rate to pralatrexate in Asian PTCL patients after prior treatment failure, as determined by independent imaging reviewer(s) using international workshop lymphoma response criteria (IWC)

Secondary objectives:

* To determine the safety of pralatrexate in Asian PTCL patients by,

  * Incidence of adverse events (AEs) and serious adverse events (SAEs) emergent from the treatment
* To evaluate the efficacy of pralatrexate in Asian PTCL patients after prior treatment failure by,

  * Overall survival (OS), progression-free-survival (PFS), complete response (CR) and partial response (PR) rate, and duration of CR and PR
  * Treatment duration with pralatrexate in the patients without hematopoietic stem cell transplant (HSCT) who achieve CR or PR
  * Percentage of patients who undergo HSCT
  * 1-year OS, 1-year PFS, and 1-year relapse rate after HSCT
  * 2-year OS, 2-year PFS, and 2-year relapse rate after HSCT

A Pralatrexate Study in Asian Patients With Peripheral T-cell Lymphoma After Prior Therapy

A Multi-Center, Open-Labelled, Pralatrexate Study in Asian Patients With Peripheral T-cell Lymphoma After Prior Therapy

Objective response rate (ORR) to pralatrexate treatment in Asian PTCL patients after prior treatment failure, as determined by independent imaging reviewer(s) using international workshop lymphoma response criteria (IWC)

Incidence of adverse events (AE) and serious adverse events (SAE) emergent from the treatment

Duration of completion response and partial response (days)

Treatment duration with pralatrexate in the patients without HSCT who achieve CR or PR

1-year overall survival rate after conducting HSCT

1-year progression-free survival rate after conducting HSCT

1-year relapse rate after conducting HSCT

2-year overall survival rate after conducting HSCT

2-year progression-free survival rate after conducting HSCT

2-year relapse rate after conducting HSCT

Taiwan Mundipharma Pharmaceuticals Ltd.

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Urinary Bladder Neoplasms

Non-Muscle Invasive Bladder Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Carcinoma

Neoplasms, Glandular and Epithelial

Motivational Interviewing with WhatsApp video call The individuals in the intervention group will be given a smoking cessation education and motivational interview with a WhatsApp video call for 3 months. The motivational interview will be applied every two weeks, 6 times in total. Self-efficacy scale and smoking behavior scale will be administered again at 3, 6 and 12 months after the intervention. tumor recurrence and progression will be checked by cystoscopy at 3rd and 12th months

the control group received the routine care/education provided in the hospital. Self-efficacy scale and smoking behavior scale will be administered again at 3, 6 and 12 months after the routin hospital care. Both intervention and control groups' tumor recurrence and progression will be checked by cystoscopy at the 3rd and 12th months

The intervention group will be given a motivational interview with a WhatsApp video call for 3 months. Motivational interviews will be applied every two weeks, 6 times in total.

Behavioral: Motivational Interviewing with WhatsApp video call

İREM NUR ÖZDEMİR, PhD, RN.

İrem Nur Özdemir, PhD, RN

This study will be carried out to examine the effect of telephone-assisted smoking cessation program on self-efficacy, smoking behavior, tumor recurrence and progression in patients with non-muscle invasive bladder cancer.

This study will be conducted to examine the effect of a telephone-assisted smoking cessation program (3 months) on self-efficacy, smoking behavior, tumor recurrence and progression for chronic disease management in patients diagnosed with non-muscle invasive bladder cancer. After 3 months of motivational interviewing was applied to the experimental group, the scales will be applied in the 3rd, 6th and 12th months. The cystoscopy will be performed at 3 and 12 months for tumor recurrence and progression

This study is a parallel group randomized controlled study.

The Effect of Telephone-Assisted Smoking Cessation Program in Patients Diagnosed With Non-Muscle Invasive Bladder Cancer

The Effect of Telephone-Assisted Smoking Cessation Program on Self-Efficacy, Smoking Behavior, Tumor Recurrence and Progression in Patients Diagnosed With Non-Muscle Invasive Bladder Cancer

The scale is rated on a 10-point scale ranging from "not at all sure" to "very sure". The score obtained from the scale is the average of 6 items, and high scores indicate high self-efficacy. If more than one answer is given to an item and the items follow each other, the lower score is included in the calculation. In order to calculate the scale, at least 4 items must be answered. The Croncbach's alpha coefficient was 0.91 and the mean of the original scale was 5.17 ± 2.22. Turkish validity and reliability was done by İncirkuş and Nahcivan (2020). The Cronbach's alpha coefficient of the scale was found to be 0.90.

The Turkish validity and reliability of the scale was done by Sancar. The scale was created as a scale with 11 questions as a result of the Turkish adaptation study, and each question is scored from 0 to 4 with a 5-option scoring system. Behavioral addiction score below 12 is mild, 12 and 22 moderate, 23-33 strong, 33 above very strong behavioral addiction score has been suggested. The scale is a valid and reliable scale that can be used to determine the behavioral aspect of smoking addiction of smokers, both in its one-dimensional and 2-dimensional form. The Croncbach alpha coefficient was found to be 0.82. This value indicates that the scale is quite reliable in terms of internal consistency. The "Conditioning and Significance" sub-dimension of the scale consists of 5 items and the Cronbach's alpha coefficient is 0.762. The "Handling and Emotions" sub-dimension consists of 6 items and the Cronbach's alpha coefficient is 0.735.

Tumor recurrence will be examined by cystoscopy at the 3rd and 12th months after the intervention.

Progression will be examined by cystoscopy at the 3rd and 12th months after the intervention.

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Behaviors and Mental Disorders

Carcinoma, Transitional Cell

Leiomyosarcoma

Quality of Life

Transitional Cell Carcinoma

A radical cystectomy is an operation to remove the whole bladder

Radical Cystectomy

Francesco Montorsi, MD

Giusy Burgio, MSc

Observational study on the quality of life and pathological state of patients underwent radical cystectomy.

Each patient will be followed for approximately 10 years starting from the date of surgery. The patient may be contacted for yearly follow-up through one of the preferred methods indicated (phone call, email or home address) which will be carried out by the staff of the Urology Department. The data for each patient will then be transferred to the database itself. The data collected will be handled following the most strict GCPs and privacy norms.

The data entered will concern:

* period before hospitalization (symptoms, clinical data) and completion of a pre-surgery questionnaire
* hospitalization period with all its related data
* questionnaires relating to quality of life which will be administered to the patient once a year according to the preferred method expressed by the patient in the informed consent.

Study on the Quality of Life and Pathological State in Patients Who Underwent Radical Cystectomy

Bladder Archive: Observational Study on the Quality of Life and Pathological State in Patients Who Underwent Radical Cystectomy

All patients, before underwent radical cystectomy, receive a diary in which we ask a detailed clinical history of the patient with their symptoms, diagnosis and previous urological e non urological treatments performed before the operation. A detailed intraoperative, postoperative and follow-up clinical history.

Through the collection of a detailed clinical history of the patient in which themselves report symptoms, diagnosis and previous urological and non-urological treatments and also through the medical record.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Phase II Multicentric Study of Pembrolizumab in Classic or Endemic Kaposi's Sarcoma	NCT03469804	Kaposi Sarcoma Progression, Di...	Pembrolizumab	18 Years -	Assistance Publique - Hôpitaux de Paris
The Effects of Using Different Anesthetics on the Prognosis of Primary Lung Tumors and Its Mechanism of Action	NCT05663242	Lung Cancer Progression, Di... Anesthesia	Propofol Sevoflurane	20 Years - 80 Years	Kaohsiung Medical University Chung-Ho Memorial Hospital
SLNB After Neoadjuvant Treatment in Node Positive Patients	NCT03833960	Sentinel Lymph ... Locoregional Ne... Progression, Di...		18 Years - 90 Years	Clinical Hospital Center Rijeka
A Pralatrexate Study in Asian Patients With Peripheral T-cell Lymphoma After Prior Therapy	NCT03150602	Peripheral T Ce... Progression, Di...	Pralatrexate	20 Years -	Taiwan Mundipharma Pharmaceuticals Ltd.
The Effect of Telephone-Assisted Smoking Cessation Program in Patients Diagnosed With Non-Muscle Invasive Bladder Cancer	NCT05704231	Non-Muscle Inva... Self Efficacy Smoking Behavio... Tumor Recurrenc... Progression, Di...	Behavioral: Mot...	21 Years -	Bakirkoy Dr. Sadi Konuk Research and Training Hospital
The Effects of Using Different Anesthetics on the Prognosis of Primary Lung Tumors and Its Mechanism of Action	NCT05663242	Lung Cancer Progression, Di... Anesthesia	Propofol Sevoflurane	20 Years - 80 Years	Kaohsiung Medical University Chung-Ho Memorial Hospital
Study on the Quality of Life and Pathological State in Patients Who Underwent Radical Cystectomy	NCT06170177	Muscle-Invasive... Muscle Invasive... Bladder Cancer ... Bladder Cancer ... Bladder Cancer ... Bladder Cancer ... Bladder Leiomyo... Bladder Cancer Bladder Cancer ... Bladder Cancer ... Bladder Cancer ... Bladder Cancer ... Bladder Urothel... Progression, Di... Urinary Diversi... Neobladder Radical Cystect...	Radical Cystect...	18 Years -	IRCCS San Raffaele

Spots Global Cancer Trial Database for progression, disease