Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Behaviors and Mental Disorders

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Quality of Life

Antineoplastic Agents

All Drugs and Chemicals

Bortezomib

Proteasome Inhibitors

Injection into a vein 1.3 mg/m2 twice a week for 21 days

bortezomib

Janssen Korea, Ltd. Clinical Trial

This observational study will observe the degree of the quality of life in patients with multiple myeloma before and after bortezomib administration by using EORTC-QLQ C30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core30) and EQ-5D (EuroQol-5 Dimensions). Both tools are validated research instruments used to measure the quality of life in cancer patients and consequently will provide fundamental data regarding the quality of life in patients with multiple myeloma by analyzing factors that affect the quality of life.

Many clinical studies for the treatment of multiple myeloma have been conducted in Korea, but none of them have evaluated the improvement in the quality of life in patients with multiple myeloma. Most study variables used to evaluate the quality of life of patients with multiple myeloma are subjective and limited. This study will observe the degree of change in the quality of life in patients with multiple myeloma before and after bortezomib administration by using EORTC-C30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core30) and EQ-5D (EuroQol-5 Dimensions), validated research instruments used to measure the quality of life in cancer patients and consequently will provide fundamental data regarding the quality of life in patients with multiple myeloma.. Observational Study - No investigational drug administered

Quality of Life in Multiple Myeloma Patients Treated With Bortezomib

Evaluation of Improvement of Quality of Life in Multiple Myeloma Patients Treated With Velcade (Bortezomib) IV: Prospective, Multicenter, Observational Study

Janssen Korea, Ltd., Korea

a representative sample from general Slovenian population

Vaneja Velenik, PhD,MD

Vesna Zadnik, PhD,MD

Vaneja Velenik, PhD, MD

Danijela Strbac, MD

The purpose of the study is to obtain reference data on health-related quality of life for the functional and symptom scales and single items of the European Organisation for Research and Treatment of Cancer Core Quality-of-Life Questionnaire (EORTC QLQ C30) in a representative sample of Slovenian general population.

A sample of at least 600 people from the Slovenian population, randomly selected, age 18 years and more, representing geografic diversity, will take part in this postal survey. The EORTC QLQ C30 and a questionnaire about demografic data will be send by mail. This is the first study to obtain reference data from the EORTC QLQ C30 in a sample from the general Slovenian population. The results will serve as guidelines for interpreting health-related quality-of-life of different groups of patients.

Health-related Quality of Life in General Slovenian Population

Health-related Quality of Life in General Slovenian Poplation Assessed by the European Organisation for Research and Treatment of Cancer (EORTC) Core Quality-of-Life Questionnaire QLQ-C30

Institute of Oncology Ljubljana

Digestive System Diseases

Esophageal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

Patient with esophageal Cancer treated by neoadjuvant chemoradiation followed by surgery will be longitudinally evaluated by questionaires EORTC QLQ C30, EORTC QLQ OES-18 and EORTC OG-25

Patient with esophageal Cancer treated by definitive chemoradiation will be longitudinally evaluated by questionaires EORTC QLQ C30, EORTC QLQ OES-18 and EORTC OG-25

EORTC QLQ C30

EORTC QLQ OES-18

EORTC OG-25

Falk Roeder, MD

Franziska Walter, MD

Sabine Gerum, MD

Michael Hoffmann, MD

Prospective observational study to evaluate the Quality of life based on standardized EORTC questionaires as well as toxicities, functional and oncological outcomes in patients treated with neoadjuvant or definitive chemoradiation for esophageal Cancer.

Prospective observational study to evaluate the Quality of life based in patients treated with neoadjuvant or definitive chemoradiation for esophageal Cancer. QoL will be evaluated by standardized EORTC questionaires. Acute and late toxicity will be assessed according to CTCAE 4.03. Outcome measures will include local Control, distant Control, freedom from Treatment failure and overall survival. Correlations are planned between Patient- and physician-assessed functional Outcome.

Prospective Observational Trial to Evaluate Quality of Life After Neoadjuvant or Definitive Chemoradiation in Patients With Esophageal Cancer

Quality of life measured by standardized EORTC questionaires

acute toxicity scored according to CTCAE 4.03

late toxicity scored according to CTCAE 4.03

Ludwig-Maximilians - University of Munich

Consultant

Anus Neoplasms

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Intestinal Diseases

Anus Diseases

Rectal Diseases

Anal Cancer

EORTC QLQ CR29

Observational study to evaluate longitudinal quality of life according to standardized EORTC questionaires as well as functional outcome, oncological outcome and toxicity in patients treated with definitive chemoradiation for anal cancer

Observational study to evaluate longitudinal quality of life according to standardized EORTC questionaires as well as functional outcome, oncological outcome and toxicity in patients treated with definitive chemoradiation for anal cancer. Qol will be evaluated by standardized EORTC questionaires QLQ C30 and QLQ CR29. Acute and late toxicity will be assessed according to CTCAE 4.03. Oncological outcome will be assessed with regard to local and distant control, patterns of recurrence, freedom from treatment failure and overall survival. Correlations of physicians- and patients-assessed functional outcomes are planned.

Prospective Observational Trial to Evaluate Quality of Life After Definitive Chemoradiation in Patients With Anal Cancer (LANACARE)

Quality of life measured by EORTC questionaire QLQC30 in absolute values at different time points and change over time

Quality of life measured by EORTC questionaire QLQCR29 in absolute values at different time points and change over time

absence of disease progression inside the target volume of radiation therapy

absence of disease progression outside the target volume of radiation therapy

absence of disease progression inside or outside the target volume of radiation therapy

acute toxicity caused by chemoradiation according to CTCAE 4.03

late toxicity caused by chemoradiation according to CTCAE 4.03

Treatment with neoadjuvant short term radiation therapy (5x5 Gy) followed by surgery. Quality of life will be assessed using the EORTC QLQ C30 and EORTC QLQ CR 29 questionaire.

Treatment with neoadjuvant Long-term chemoradiation followed by surgery. Quality of life will be assessed using the EORTC QLQ C30 and EORTC QLQ CR 29 questionaire

Observational study to evaluate longitudinal quality of life according to standardized EORTC questionaires as well as functional Outcome, oncological outcome and toxicity in patients treated with neoadjuvant short term radiation or long-term chemoradiation followed by surgery

Observational study to evaluate longitudinal quality of life in patients treated with neoadjuvant short-course Irradiation or neoadjuvant Long-Course chemoradiation followed by surgery. QoL will be evaluated by standardized EORTC questionaires QLQ C30 and CR29. Acute and late toxicity will be assessed according to CTCAE 4.03. Oncological Outcome will be assessed with regard to local and distant Control, Patterns of recurrence, freedom from Treatment failure and Overall survival. Correlations of physicians- and Patient-assessed functional outcomes are planned.

Prospective Observational Trial to Evaluate Quality of Life After Neoadjuvant Radiation or Chemoradiation Followed by Surgery in Patients With Rectal Cancer

Radiation or Chemoradiation Followed by Surgery in Patients With Rectal Cancer

Quality of life measured by EORTC questionaires QLQC30 in absolute values at different time points and change over time

Quality of life measured by EORTC questionaires QLQCR29 in absolute values at different time points and change over time

acute toxicity by Radiation or chemoradiation according to CTCAE 4.03

Hypersensitivity

Patients with adjuvant or definitve radiotherapy or radio-chemotherapy for head and neck cancer

3x3 OCT volume scans on treated and opposite side of the irreadiated area on head and neck

Dermatoscope

Blood sample is examined for breaks per metaphase to determine radiation sensibility of the individual

3-Colour FISH

Elisabeth Silberberger, MSc

Hans Geinitz, Prim. Univ.-Prof. Dr.

Elisabeth Silberberger, MSC

The purpose of this study is to determine whether any eventual skin damage caused by radiation therapy can be detected and monitored at a subclinical level via optical coherence tomography (OCT). Another key question is whether subclinical OCT detected skin damage correlates with acute and late clinical toxicity.

Head and neck cancer patients that meet the eligibility criteria and singned the informed consent will undergo OCT-measurements before, during and after the course of radiation therapy. At the same time-points the skin areas are evaluated with dermatoscopy and patients are asked to self-assess their quality of life (EORTC QLQ C30 and respective head and neck module H\&N 43). Before the onset of radiation therapy radiation sensitivity analysis will be performed with in-vitro irradion of peripheral blood lymphocytes (FISH).

Optical Coherence Tomography in Patients With Radiotherapy for Head and Neck Cancer

Live Laser Microscopic Evaluation (OCT) of Radiation Induced Preclinical Alterations of the Skin in Head and Neck Cancer Patients

any reproducible difference in skin OCT appearance as compared with baseline (pre-RT)

Correlation of OCT changes with CTC radiation toxicity

Correlation of OCT with chromosome-breaks per metaphasis in in-vitro irradiated blood lymphocytes (FISH)

Correlation of OCT changes with standardised evaluated skin appearence via dermatoscopy

Correlation of quality of live as measured with the EORT QLC C30 and Head and neck module H\&N 43 with OCT and radiation sensitivity

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Quality of Life in Multiple Myeloma Patients Treated With Bortezomib	NCT01021592	Multiple Myelom...	bortezomib	18 Years -	Janssen Korea, Ltd., Korea
Health-related Quality of Life in General Slovenian Population	NCT01269489	Health-related ...		18 Years - 90 Years	Institute of Oncology Ljubljana
Prospective Observational Trial to Evaluate Quality of Life After Neoadjuvant or Definitive Chemoradiation in Patients With Esophageal Cancer	NCT03712774	Quality of Life Chemoradiation Esophageal Canc...	EORTC QLQ C30 EORTC QLQ OES-1... EORTC OG-25	18 Years -	Ludwig-Maximilians - University of Munich
Prospective Observational Trial to Evaluate Quality of Life After Definitive Chemoradiation in Patients With Anal Cancer (LANACARE)	NCT03792854	Anal Cancer Quality of Life Chemoradiation	EORTC QLQ C30 EORTC QLQ CR29	18 Years -	Ludwig-Maximilians - University of Munich
Prospective Observational Trial to Evaluate Quality of Life After Neoadjuvant Radiation or Chemoradiation Followed by Surgery in Patients With Rectal Cancer	NCT03731130	Rectal Cancer Quality of Life Radiation Thera... Chemoradiation	EORTC QLQ C30 EORTC QLQ CR29	18 Years -	Ludwig-Maximilians - University of Munich
Optical Coherence Tomography in Patients With Radiotherapy for Head and Neck Cancer	NCT04610645	Head and Neck C... Radiotherapy	OCT Dermatoscope 3-Colour FISH	18 Years - 99 Years	Krankenhaus Barmherzige Schwestern Linz
Quality of Life in Multiple Myeloma Patients Treated With Bortezomib	NCT01021592	Multiple Myelom...	bortezomib	18 Years -	Janssen Korea, Ltd., Korea
Prospective Observational Trial to Evaluate Quality of Life After Definitive Chemoradiation in Patients With Anal Cancer (LANACARE)	NCT03792854	Anal Cancer Quality of Life Chemoradiation	EORTC QLQ C30 EORTC QLQ CR29	18 Years -	Ludwig-Maximilians - University of Munich
Health-related Quality of Life in General Slovenian Population	NCT01269489	Health-related ...		18 Years - 90 Years	Institute of Oncology Ljubljana

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