UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051734 |
|---|---|
| Receipt number | R000058871 |
| Scientific Title | A prospective cohort study regarding the prognosis, comprehensive geriatric assessment, and health-related QoL in elderly patients with early upper gastrointestinal cancers |
| Date of disclosure of the study information | 2023/07/28 |
| Last modified on | 2023/07/28 05:43:58 |
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Basic information
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
Condition
Patients aged 75 years or older with early upper gastrointestinal cancers
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
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
Assessment
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
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
| 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
Research contact person
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
waku-style@festa.ocn.ne.jp
Public contact
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
gmaps177@gmail.com
Sponsor or person
Institute
Tohoku University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
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
ec@rinri.hosp.tohoku.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 07 | Month | 28 | Day |
Related information
URL releasing protocol
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
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
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.
Management information
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/ctr_e/ctr_view.cgi?recptno=R000058871
