UMIN-CTR Clinical Trial

Public title

An Exploratory Study of Senescence Associated Glycoprotein (SAGP) in Idiopathic Pulmonary Fibrosis: A Cross Sectional Study Using Blood and Lung Tissue Samples

Acronym

IPF-SAGP Study

Scientific Title

Exploratory Investigation of Senescence-Associated Glycoprotein (SAGP) Expression in Idiopathic Pulmonary Fibrosis: A Cross-Sectional Observational Study Using Peripheral Blood and Lung Tissue

Scientific Title:Acronym

SAGP-IPF Cross-Sectional Study

Region

Japan

Condition

Idiopathic pulmonary fibrosis

Classification by specialty

Medicine in general	Cardiology	Pneumology
Geriatrics	Chest surgery

Classification by malignancy

Others

Genomic information

YES

Narrative objectives1

The objective of this study is to investigate the presence and expression of senescence-associated glycoprotein (SAGP) in patients with idiopathic pulmonary fibrosis (IPF) using peripheral blood and lung tissue samples. Specifically, we aim to measure circulating SAGP levels in patients with IPF and explore their associations with clinical parameters, including pulmonary function, radiologic findings, established biomarkers, and DNA methylation profiles. In cases undergoing diagnostic lung biopsy, protein analysis and single-cell analysis will be performed to identify SAGP-positive cells and characterize their cell-type specificity, thereby clarifying the involvement of cellular senescence in the pathogenesis of IPF.

Basic objectives2

Bio-availability

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable

Primary outcomes

Examination of senescence-associated glycoprotein (SAGP) expression in lung tissue assessed in patients undergoing diagnostic lung biopsy

Key secondary outcomes

Circulating SAGP level at the time of sample collection after informed consent
Association between circulating SAGP levels and pulmonary function parameters (VC, FVC, DLco)
Association between circulating SAGP levels and established biomarkers (KL-6, SP-D, proBNP)
Association between circulating SAGP levels and DNA methylation profiles

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

16

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Individuals aged 16 years or older at the time of obtaining informed consent.

2. Individuals who are suspected of having or have been diagnosed with idiopathic pulmonary fibrosis.

3. Individuals who have received sufficient explanation about the study and have provided written informed consent of their own free will.

Key exclusion criteria

Individuals who are judged by the principal investigator to be inappropriate for participation in this study.

Target sample size

40

Name of lead principal investigator

1st name	Tohru
Middle name
Last name	Minamino

Organization

Juntendo University Hospital

Division name

Department of Cardiovascular Biology and Medicine

Zip code

113-8431

Address

3-1-3 Hongo, Bunkyo-ku, Tokyo

TEL

03-3813-3111

Email

t.minamino@juntendo.ac.jp

Name of contact person

1st name	Yusuke
Middle name
Last name	Joki

Organization

Juntendo University Hospital

Division name

Department of Cardiovascular Biology and Medicine

Zip code

113-8431

Address

3-1-3 Hongo, Bunkyo-ku, Tokyo

TEL

03-3813-3111

Homepage URL

Email

yjyouki@juntendo.ac.jp

Institute

Juntendo University Hospital

Institute

Department

Personal name

Organization

Departmental research funding, Juntendo University Hospital

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Medical Research Ethics Committee, Juntendo University

Address

3-1-3 Hongo, Bunkyo-ku, Tokyo

Tel

03-3814-5672

Email

hongo-rinri@juntendo.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

04

Month

01

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

Preinitiation

Date of protocol fixation

2026

Year

03

Month

10

Day

Date of IRB

Anticipated trial start date

2026

Year

04

Month

01

Day

Last follow-up date

2031

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

This is a single-center cross-sectional observational study. Patients who are suspected of having or have been diagnosed with idiopathic pulmonary fibrosis will be evaluated at the time of sample collection after informed consent. SAGP expression will be assessed using peripheral blood samples and lung tissue samples obtained during diagnostic biopsy when available. An additional blood sample of approximately 10 mL will be collected for research purposes. No therapeutic intervention or longitudinal follow-up will be conducted.

Registered date

2026

Year

03

Month

11

Day

Last modified on

2026

Year

03

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069692