UMIN-CTR Clinical Trial

Public title

A prospective study of quality of life in patients with renal cell carcinoma: the impact of the type of surgery on quality of life.

Acronym

A prospective study of quality of life in patients following surgical treatment.

Scientific Title

A prospective study of quality of life in patients with renal cell carcinoma: the impact of the type of surgery on quality of life.

Scientific Title:Acronym

A prospective study of quality of life in patients following surgical treatment.

Region

Japan

Condition

Renal cell carcinoma

Classification by specialty

Urology

Classification by malignancy

Malignancy

Genomic information

NO

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

Primary outcomes

Health Related QOL,HAD

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Nobuo Shinohara

Organization

Graduate School of Medicine, Hokkaido University

Division name

Department of Renal and Genitourinary surgery

Zip code

Address

N15 W7 Kita-ku, Sapporo

TEL

011-706-5966

Email

nozomis@mbj.nifty.com

Name of contact person

1st name
Middle name
Last name	Sachiyo Murai

Organization

Graduate School of Medicine, Hokkaido University

Division name

Department of Renal and Genitourinary surgery

Zip code

Address

N15 W7 Kita-ku, Sapporo,

TEL

011-706-5966

Homepage URL

Email

u-ikyoku@med.hokudai.ac.jp

Institute

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

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2015

Year

10

Month

23

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Enrolling by invitation

Date of protocol fixation

2010

Year

12

Month

07

Day

Date of IRB

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

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

Registered date

2015

Year

10

Month

23

Day

Last modified on

2016

Year

11

Month

02

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022516