Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Carcinoma, Renal Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

All Drugs and Chemicals

Amino Acids

Tyrosine Kinase Inhibitors

Tyrosine

All dosage, frequency and duration for drugs will be under the decision of the treating physician

No intervention

Bayer Study Director

This study is a prospective, non-interventional, non-controlled, multi-center, observational cohort study. The medication is prescribed within the regular practice of the physician. Duration and dosage of treatment is solely at the discretion of the attending physician. The primary objective of this study is to assess duration of treatment in Turkish renal cell carcinoma patients treated with TKIs (Tyrosine Kinase Inhibitors) who could not tolerate prior cytokine treatment within the first month of treatment.

Duration of Treatment With Tyrosine Kinase Inhibitors in the Treatment of Metastatic Renal Cell Carcinoma

Duration of Treatment With TKIs in the Treatment of Metastatic Renal Cell Carcinoma

Bayer

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Antineoplastic Agents

Lenalidomide

Subjects should be chosen among relapse/refractory multiple myeloma patients who have received at least one prior antimyeloma chemotherapy regimen (excluding treatment regimens with steroid only) with adequate dose and duration (≥2 cycles) or who have relapse/refractory multiple myeloma after stem cell transplantation.

Patients who are eligible for the study will be consecutively enrolled in the study until the targeted patient number is reached. The responsible investigator will be requested to keep a log of subjects who are invited to enter the study. In the case of any of these subjects will not be enrolled in the study, this information will be documented together with its reason

Margaret Atiba-Davies, PhD

CC-5013-PASS-TR/A non-interventional, multi-center, observational post authorization safety study of patients with relapsed/refractory multiple myeloma treated with Lenalidomide in Turkey.

The study is anticipated to last for approximately 8 years. Recruitment period will continue until 500 subjects have commenced the third cycle of treatment with lenalidomide.

Objectives:

- Primary: To characterize and determine the incidence of adverse events of special interest; in subjects treated with Lenalidomide in real life setting in given indication.

- Secondary:

1. To observe the basic adverse event management approaches of physicians
2. To evaluate the effectiveness of Lenalidomide in given indication and to evaluate the prescription line.
3. To monitor the reasons of patients' noncompliance with lenalidomide usage recommended in Patient Information Leaflet.

Subjects will be recruited from approximately 36 hematology/oncology sites in Turkey. In all cases, the decision to treat the patient will be made prior to the decision to enter the subject into the study. All subjects enrolled will be prospectively followed up for up to 36 months, where feasible, following the end of observed treatment period. This 36 month observation period will start from end of treatment. The observation follow up period will end 36 months after the end of lenalidomide or background observed treatment period, or at time of death, withdrawal of consent, or loss to follow up. Following completion of treatment, subjects will be followed up after 30 days and then every 6 months to assess status.

Patients who are eligible and signed a consent form will be recruited consecutively. Subjects who temporarily discontinue treatment for any reason for more than 30 days will be withdrawn from treatment observation but will be observed for safety for up to 36 months (from the end of treatment). If the reason for discontinuation for subjects is due to an adverse event, the follow up of the adverse event will not be time limited and will continue until resolution or stabilization or when, in the opinion of the investigator, no additional useful information can be obtained from the event or the subject withdraws their consent to any more data being collected. Subjects will discontinue from the study if they switch to another treatment. No intervention will be performed to physician. Treatment will be according to physician's regular clinical practice.

All treatments will be prescribed by the treating investigator in accordance with regular clinical practice.

All assessments will be made according to the regular clinical practice of the treating investigator. Therefore if a parameter is requested on the case report form (CRF) but the investigator's normal practice is not to carry out such an assessment, then the field will not be completed.

Statistical Analysis:

Data from all subjects who receive at least one dose of treatment will be included in the safety analysis.

Adverse events will be classified using the MedDRA classification system. The severity of the toxicities will be graded according to the NCI CTCAE V. 4.03 whenever possible.

Adverse event frequency will be tabulated by body system and MedDRA term. In the by subject analysis, a subject having the same event more than once will be counted only once. Adverse events will be summarized by worst NCI CTCAE V. 4.03 grade.

Adverse events leading to death or to discontinuation from treatment, study-drug-related events, and serious adverse events will be listed separately.

The Kaplan-Meier procedures will be used to characterize time to onset and time to resolution for adverse events of special interest. Multivariate logistic regression will be used to determine the demographic and baseline characteristics most predictive of developing adverse events of interest. A forward selection stepwise procedure will be used to identify the subset of relevant factors.

Summary tables will also be provided for clinically relevant subgroups. Analyses will be undertaken to explore the course of neuropathy for subjects who have pre-existing neuropathy at baseline. Specifically, cross-tabulations will be used to summarize changes in severity observed during lenalidomide treatment and summary statistics will be provided for other relevant variables.

A Non-interventional,Observational Post Authorization Study of Patients With Multiple Myeloma Treated With Lenalidomide TR

A Non-interventional, Multi-center, Observational Post Authorization Safety Study of Patients With Relapse/Refractory Multiple Myeloma Treated With Lenalidomide in Turkey

Number of participants with Adverse Events

Celgene

Skin and Connective Tissue Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Trametinib

Dabrafenib

Protein Kinase Inhibitors

Enzyme Inhibitors

patients on adjuvant treatment with dabrafenib + trametinib

There is no treatment allocation. Patients administered dabrafenib by prescription that have started before inclusion of the patient into the study will be enrolled.

dabrafenib

There is no treatment allocation. Patients administered trametinib by prescription that have started before inclusion of the patient into the study will be enrolled.

trametinib

Novartis Pharmaceuticals

Non-interventional (observational) cohort prospective real life study with primary and secondary data collection from patients on adjuvant treatment with dabrafenib + trametinib in patients with completely resected high-risk stage III (stage IIIA \[lymph node \> 1mm\], IIIB, IIIC and IIID according to AJCC 8th edition) melanoma in Turkey.

The prospective registration of completely resected high-risk stage III melanoma patients treated with dabrafenib and trametinib in the adjuvant setting will be based on collaboration with centers of excellence on melanoma patients treatment. Pre-identified centers (up to 12) considered as the most advanced according to their knowledge and experience, will take part in the patients recruitment.

Adjuvant Dabrafenib and Trametinib Treatment in Patients With Completely Resected High-risk Stage III Melanoma.

A Real-life Study to Evaluate the Use of Adjuvant Treatment With Dabrafenib and Trametinib in Routine Practice in Patients With Completely Resected High-risk Stage III Melanoma

RFS is the length of time after primary treatment for a cancer ends that the patient survives without any signs or symptoms of that cancer.

Total duration of treatment defined as median time on adjuvant dabrafenib + trametinib treatment (from start to end of treatment/permanent treatment discontinuation).

Collection of number of patients on treatment

Rate of permanent study drug discontinuation due to any reason will be collected

Rate of permanent drug discontinuation due to pyrexia and other AEs will be collected

Collection of incidence and severity of Adverse Events

Collection of procedures of the management of Adverse Events (AEs)

death, relapse, AEs, withdrawal of consent, other

Average dose of dabrafenib and trametinib used during the treatment including dose reductions.

collection of the proportion of patients with dabrafenib and trametinib dose reduction during treatment

Collection of the reason for dabrafenib and trametinib dose reduction

Collection of the type of relapse: local, regional or distant

Omur Gokmen Sevindik, Assoc. Prof.

Ilker Kurkcu, Pharm

Gokme Sevindik

This is a non-interventional, national, multi center, prospective multiple myeloma registry in Turkey

In this study, approximately from 40 centers 1000 patients will be recruited. All patients will be followed-up till the study end.

All the laboratory results, treatment protocols and responses will be recorded and assessed with EORTC Multiple Myeloma Specific Quality of Life Multiple Myeloma Specific (MY-20) and EORTC Quality of Life-C30 questionnaires.

Multiple Myeloma Turkish Prospective Patient Registry

Multiple Myeloma Patient Registry - Prospective National Multi Center Prospective Study

Time from the initiation of treatment to the death from any cause or progression

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Duration of Treatment With Tyrosine Kinase Inhibitors in the Treatment of Metastatic Renal Cell Carcinoma	NCT01585974	Renal Cell Carc...	No intervention	18 Years -	Bayer
A Non-interventional,Observational Post Authorization Study of Patients With Multiple Myeloma Treated With Lenalidomide TR	NCT02387879	Multiple Myelom...		18 Years -	Celgene
Adjuvant Dabrafenib and Trametinib Treatment in Patients With Completely Resected High-risk Stage III Melanoma.	NCT04961619	Melanoma	dabrafenib trametinib	18 Years -	Novartis
Multiple Myeloma Turkish Prospective Patient Registry	NCT04143932	Multiple Myelom... Relapse Multipl...		18 Years -	Turkish Hematology Association

Spots Global Cancer Trial Database for turkey

Every month we try and update this database with for turkey cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for turkey

Every month we try and update this database with for turkey cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for turkey cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.