UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041858
Receipt number R000047787
Scientific Title Nutritional status of postoperative patients with gastric cancer
Date of disclosure of the study information 2020/09/25
Last modified on 2020/09/22 08:30:53

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Basic information

Public title

Nutritional status of postoperative patients with gastric cancer

Acronym

Nutritional status of postoperative patients with gastric cancer

Scientific Title

Nutritional status of postoperative patients with gastric cancer

Scientific Title:Acronym

Nutritional status of postoperative patients with gastric cancer

Region

Japan


Condition

Condition

Gastric cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate and study the nutritional status of patients with gastric cancer after gastrectomy.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Post-operative weight loss rate in gastric cancer patients

Key secondary outcomes

Calculation of visceral fat, subcutaneous fat, abdominal circumference, and area and volume of the psoas muscle by preoperative CT in patients with gastric cancer and evaluation of the rate of reduction.
The rate of change of CT values within the psoas muscle preoperatively and postoperatively.


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) 20 year over.
2) Histologically diagnosed with gastric cancer.
3) Resectability of R0.

Key exclusion criteria

1) Patients who do not have preoperative and postoperative CT data.
2) Patients who are unable to give consent to participate in the study.

Target sample size

500


Research contact person

Name of lead principal investigator

1st name Sachiko
Middle name
Last name Kaida

Organization

Shiga University of Medical Science

Division name

Department of Surgery

Zip code

520-2192

Address

Tsukinowa-cho, Seta, Otsu, Shiga

TEL

077-548-2238

Email

kaida@belle.shiga-med.ac.jp


Public contact

Name of contact person

1st name Sachiko
Middle name
Last name Kaida

Organization

Shiga University of Medical Science

Division name

Department of Surgery

Zip code

520-2192

Address

Tsukinowa-cho, Seta, Otsu, Shiga

TEL

077-548-2238

Homepage URL


Email

kaida@belle.shiga-med.ac.jp


Sponsor or person

Institute

Department of Surgery, Shiga University of Medical Science

Institute

Department

Personal name



Funding Source

Organization

Department of Surgery, Shiga University of Medical Science

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Shiga University of Medical Science

Address

Tsukinowa-cho, Seta, Otsu, Shiga

Tel

077-548-2238

Email

kaida@belle.shiga-med.ac.jp


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

滋賀医科大学医学部附属病院


Other administrative information

Date of disclosure of the study information

2020 Year 09 Month 25 Day


Related information

URL releasing protocol

http://www.shiga-med.ac.jp/~hqsurge1/pg288.html#rinnsyokenkyu

Publication of results

Unpublished


Result

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



Progress

Recruitment status

Open public recruiting

Date of protocol fixation

2018 Year 08 Month 16 Day

Date of IRB

2018 Year 08 Month 16 Day

Anticipated trial start date

2018 Year 08 Month 16 Day

Last follow-up date

2026 Year 12 Month 31 Day

Date of closure to data entry

2026 Year 12 Month 31 Day

Date trial data considered complete

2026 Year 12 Month 31 Day

Date analysis concluded

2027 Year 03 Month 31 Day


Other

Other related information

An observational study using existing materials. The following information will be collected and measured.
1) Preoperative status (age, gender, weight, BMI, preoperative stage, preoperative blood sampling to assess nutritional status, preoperative CT to measure subcutaneous fat volume, visceral fat volume, psoas muscle mass, and abdominal circumference).
2) Surgical outcomes (approach, operative time, blood loss, etc.)
3) Short-term post-operative outcomes (post-operative complications, length of hospital stay, and final stage of illness)
4) Long-term prognosis (recurrence or not, measurement of subcutaneous fat volume, visceral fat volume, psoas muscle volume and abdominal circumference by CT scan 1-5 years after surgery)


Management information

Registered date

2020 Year 09 Month 22 Day

Last modified on

2020 Year 09 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047787


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name