UMIN-ICDS Clinical Trial

Public title

A prospective cohort study regarding the prognosis, comprehensive geriatric assessment, and health-related QoL in elderly patients with early upper gastrointestinal cancers

Acronym

UGIE study

Scientific Title

A prospective cohort study regarding the prognosis, comprehensive geriatric assessment, and health-related QoL in elderly patients with early upper gastrointestinal cancers

Scientific Title:Acronym

UGIE study

Region

Japan

Condition

Patients aged 75 years or older with early upper gastrointestinal cancers

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

YES

Narrative objectives1

To reveal factors related to prognosis and impaired HR-QoL in elderly patients with early upper gastrointestinal cancers

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Factors related to the prognosis at 3 years after the treatment

Key secondary outcomes

1. The relationship between impaired HR-QoL and sarcopenia or CGA
2. Factors related to impaired HR-QoL at 3 years after the treatment
3. The relationship between the definite diagnosis of sarcopenia and sarcopenia diagnosed by CT
4. Transition of HR-QoL and CGA
5. Prognosis and factors related to prognosis at 1 year and 5 years after the treatment
6. Prevalence and mortality of other organ cancers detected by CT and factors related to them
7. The relationship between sarcopenia-related genes and sarcopenia at 80 years
8. The relationship between sarcopenia-related genes and prognosis

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

75

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

(1) Patients diagnosed with esophageal/gastric/duodenal tumors by endoscopy
(2) Patients diagnosed with cancer by biopsy, or those with tumors strongly suspicious of cancers based on endoscopic findings
(3) Patients with esophageal/gastric/duodenal cancers confined to submucosal layer according to endoscopic diagnosis
(4) Patients aged 75 years or older
(5) Patients with written informed consent for study participation

Key exclusion criteria

(1) Patients who refused to participate in this study
(2) Patients with esophageal/gastric/duodenal cancers which are suspicious of recurrence
(3) Patients who are deemed inappropriate for the study by the investigators

Target sample size

300

Name of lead principal investigator

1st name	Waku
Middle name
Last name	Hatta

Organization

Tohoku University Graduate School of Medicine

Division name

Division of Gastroenterology

Zip code

980-8574

Address

1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan

TEL

022-717-7171

Email

waku-style@festa.ocn.ne.jp

Name of contact person

1st name	Yohei
Middle name
Last name	Ogata

Organization

Tohoku University Graduate School of Medicine

Division name

Division of Gastroenterology

Zip code

980-8574

Address

1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan

TEL

022-717-7171

Homepage URL

Email

gmaps177@gmail.com

Institute

Tohoku University Graduate School of Medicine

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

the Ethics Committee of Tohoku University Graduate School of Medicine

Address

1-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan

Tel

022-728-4105

Email

ec@rinri.hosp.tohoku.ac.jp

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

2023

Year

07

Month

28

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

2023

Year

07

Month

26

Day

Date of IRB

2023

Year

07

Month

26

Day

Anticipated trial start date

2023

Year

07

Month

28

Day

Last follow-up date

2032

Year

06

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

In this study, we will conduct evaluation of baseline characteristics, treatment methods, comprehensive geriatric assessment, sarcopenia, and HR-QoL before the treatment in patients aged 75 or older with esophageal superficial cancer, early gastric cancer, and early duodenal cancer. Additionally, we will evaluate sarcopenia-related genes. The study aims to evaluate the temporal changes in comprehensive geriatric assessment, sarcopenia, and HR-QoL post-treatment, and also aims to identify factors related to prognosis and impaired HR-QoL.

Registered date

2023

Year

07

Month

28

Day

Last modified on

2023

Year

07

Month

28

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058871