UMIN-ICDS Clinical Trial

Public title

Frailty Assessment for Predicting Outcomes after Endoscopic Treatment of Early Gastrointestinal Cancer in Elderly Patients Aged 75 Years or Older

Acronym

FORECAST (Functional Outcome Prediction by Comprehensive Assessment before ESD)

Scientific Title

A Prospective Observational Study on the Prediction of Functional Outcomes Using Multifaceted Geriatric Assessment Tools (CGA7, G8, CFS) in Patients Aged 75 Years or Older Undergoing Endoscopic Submucosal Dissection (ESD) for Early Gastrointestinal Cancer

Scientific Title:Acronym

FORECAST (Functional Outcome Prediction by Comprehensive Assessment before ESD)

Region

Japan

Condition

Esophageal cancer, Stomach cancer, Colorectal cancer

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

With the aging of the population, endoscopic submucosal dissection (ESD) is increasingly being performed in late-elderly patients aged 75 years and older. Although ESD is minimally invasive, in elderly patients the principal concern is not the procedure itself but rather the systemic complications it may precipitate, such as pneumonia and delirium. Even when the cancer is curatively resected, a situation in which discharge to home becomes difficult owing to an irreversible decline in activities of daily living (ADL) should be avoided; however, objective preoperative indices for predicting such outcomes have not yet been established.
We hypothesize that systemic vulnerability (frailty) in late-elderly patients is a predictor of "functional breakdown." In this study, using three indices that can be assessed within a short time - CGA7, G8, and CFS - we examine whether preoperative frailty classification is independently associated with major adverse functional events (MAFE) within 30 days after the procedure. We also compare the three indices to determine which most precisely predicts prognosis.

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Baseline Assessment (at admission)
Informed consent for study participation is obtained at admission. The following assessments are then performed before the procedure.
Predictors:
CGA7: A score of >=1 is defined as Frail, and a score of 0 as Robust.
G8 (Geriatric-8): A score of <=14 is defined as Frail, and >=15 as Robust.
CFS (Clinical Frailty Scale): A score of >=5 is defined as Frail, and <=4 as Robust. (Scored by two assessors who reach a consensus score.)

Outcome measures:
ADL: Barthel Index (BI) score
QOL: EQ-5D-5L score
Discharge destination (home, institution, etc.)

Intraprocedural and In-hospital Assessment
Outcomes (Tier 3): Occurrence of delirium, pneumonia, or thromboembolism during hospitalization
Outcomes (Tier 5): Procedure-related adverse events (postoperative bleeding, perforation)
Outcomes (Tier 6): Prolonged length of hospital stay

30-Day Follow-up (+/-7 days)
At the first outpatient visit after discharge, or by telephone interview, the following primary and secondary endpoints are assessed.
Outcome (Tier 1): All-cause mortality
Outcome (Tier 2): Non-home discharge (institution or hospital)
Outcome (Tier 4): ADL decline (a decrease of >=10 points in the Barthel Index)
Others: Unplanned readmission; QOL (EQ-5D-5L)

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

75

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who meet all of the following criteria are eligible for inclusion in the study.
1 Men and women aged 75 years or older
2 Patients scheduled to undergo elective ESD (esophageal, gastric, or colorectal)
3 Patients from whom written informed consent for participation in this study has been obtained, either from the patient or a legally authorized representative

Key exclusion criteria

Patients who meet any of the following criteria are excluded from the study.

1 Patients with severe dementia or psychiatric illness that makes it difficult to obtain informed consent for study participation
2 Patients in whom assessment using CGA7, G8, or CFS is judged to be infeasible owing to their physical condition at baseline (e.g., complete bed rest, severe paralysis)
3 Patients with a malignancy or severe organ failure for whom life expectancy is estimated to be less than 6 months
4 Patients who have already been enrolled in this study for another ESD procedure during the enrollment period (i.e., a second or subsequent procedure in the same patient)

Target sample size

330

Name of lead principal investigator

1st name	Youske
Middle name
Last name	Tsuji

Organization

Tokyo University

Division name

Gastroenterology

Zip code

113-8655

Address

7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033, Japan

TEL

03-3815-5411

Email

inouek-int@h.u-tokyo.ac.jp

Name of contact person

1st name	Kaoru
Middle name
Last name	Inoue

Organization

Tokyo University

Division name

Gastroenterology

Zip code

113-8655

Address

7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033, Japan

TEL

03-3815-5411

Homepage URL

Email

inouek-int@h.u-tokyo.ac.jp

Institute

Tokyo University

Institute

Department

Personal name

Organization

This study is conducted using the operating grant of Laboratory 406, Department of Gastroenterology, Graduate School of Medicine, Faculty of Medicine, The University of Tokyo.

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Department of Gastroenterology, The University of Tokyo Hospital

Address

7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033, Japan

Tel

03-3815-5411

Email

inouek-int@h.u-tokyo.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

2026

Year

08

Month

25

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

Open public recruiting

Date of protocol fixation

2026

Year

02

Month

21

Day

Date of IRB

2026

Year

03

Month

19

Day

Anticipated trial start date

2026

Year

05

Month

29

Day

Last follow-up date

2030

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Non-interventional, single-center, prospective observational cohort study.
Temporal direction: Prospective. Exposure is measured before ESD (on admission); outcomes are followed prospectively to day 30.
Sampling: No random or case-control sampling. All consecutive patients aged 75 or older scheduled for elective ESD at our hospital who meet the eligibility criteria and give written consent are enrolled. There is no allocation; patients are classified post hoc as Frail or Robust by the pre-procedural assessment.
Exposure examined: Pre-procedural frailty. Before ESD, study physicians apply three tools, each dichotomizing patients independently: CGA7 (frail, 1 point or more), G8 (frail, 14 points or less), CFS (frail, 5 or more; rated by two assessors).
Outcome examined: The primary outcome is the Major Adverse Functional Event (MAFE) within 30 days after ESD, a hierarchical composite analyzed by the win ratio (adjusted for procedure site, age, Charlson Comorbidity Index, procedure time, and albumin). Hierarchy: Tier 1 all-cause death > 2 non-home discharge > 3 systemic dysfunction (pneumonia, delirium, thromboembolism) > 4 ADL decline (Barthel Index drop of 10 points or more) > 5 procedure-related events (delayed bleeding, perforation) > 6 prolonged hospitalization. Secondary: unplanned readmission, change in EQ-5D-5L, each MAFE component, and comparison of the predictive accuracy of the three tools.
Schedule: At baseline (admission), the three tools, Barthel Index, EQ-5D-5L, residential status, and age, sex, BMI, comorbidity index and albumin from records. During hospitalization, Tier 3, 5 and 6 events, Barthel Index at discharge and discharge destination from records. At 30 days (+/-7), Tier 1, 2 and 4 events, unplanned readmission and EQ-5D-5L by outpatient visit or telephone; the only follow-up point.
Intervention: None. All care including ESD is routine practice; no treatment is altered and no samples or extra tests are taken.

Registered date

2026

Year

08

Month

25

Day

Last modified on

2026

Year

08

Month

25

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070497