UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A prospective study of quality of life in patients with renal cell carcinoma: the impact of the type of surgery on quality of life.
Title of the study (Brief title)	A prospective study of quality of life in patients following surgical treatment.
Region	Japan

Condition
Condition	Renal cell carcinoma
Classification by specialty	Urology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To describe the quality of life (QOL) over time for patients with renal cell carcinoma and to examine the relationship between QOL and outcome data collected between two prospective groups treated with radical nephrectomy or partial nephrectomy.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Health Related QOL,HAD
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Stage T1 Renal Cell Carcinoma patients 2) equal or more than 20 yo at the time of consent 3) Patient after receiving a sufficient explanation Upon participation in this study , on the thorough understanding , that document consent is obtained by the free will of the patient himself.
Key exclusion criteria	1) Patients with metastatic disease 2) Patients principal investigator has determined to be inappropriate as a subject
Target sample size	200

Research contact person
Name of lead principal investigator	Nobuo Shinohara
Organization	Graduate School of Medicine, Hokkaido University
Division name	Department of Renal and Genitourinary surgery
Address	N15 W7 Kita-ku, Sapporo
TEL	011-706-5966
Email	nozomis@mbj.nifty.com

Public contact
Name of contact person	Sachiyo Murai
Organization	Graduate School of Medicine, Hokkaido University
Division name	Department of Renal and Genitourinary surgery
Address	N15 W7 Kita-ku, Sapporo,
TEL	011-706-5966
Homepage URL
Email	u-ikyoku@med.hokudai.ac.jp

Sponsor
Institute	Department of Renal and Genitourinary surgery, Graduate School of Medicine, Hokkaido University
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2015 Year 10 Month 23 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2010 Year 12 Month 07 Day
Anticipated trial start date	2011 Year 07 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Research Methods (1) Research the type and design Prospective observational study (2) And it is the treatment method observation of the target Hokkaido following radical surgery that is usually performed in a hospital urology. Renal tumor laparotomy nephrectomy Laparotomy partial nephrectomy Arthroscopic nephrectomy Endoscopic Partial resection (3) Observation and inspection item and its implementation i) medical information of the patient Diagnosis, age, gender, physical findings (height, weight), history (diabetes, the presence or absence of heart disease, anti-platelet drugs and warfarin oral), method of treatment, staging, pathological diagnosis result, hospitalization period, the merger in hospital disease, the presence or absence of recurrence presence or absence of (recurrence day) survival / death record (such as date of death), Health related QOL (SF-36), Hospital anxiety and depression (HAD) with respect by questionnaire (questionnaire, and directly to the patient home sending), diagnostic imaging (chest X-ray, CT, renal, bone scintigraphy, etc.) ii) body composition change During hospital after cancer treatment, it is carried out the body composition measuring body weight, together with the height measured by using a general-purpose equipment. Body composition measurement using the Tanita Corp. body composition meter DC-320. (4) study participants scheduled period of the subject We participate for five years as the day before surgery and the subsequent observation period. Research implementation period December 7, 2010 (date of approval) - March 30, 2018 Registration period December 7, 2010 (date of approval) - January 30, 2018

Management information
Registered date	2015 Year 10 Month 23 Day
Last modified on	2016 Year 11 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022516