UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000045076
Receipt number R000049512
Scientific Title Study of usefulness of diagnosis of MALT lymphoma using endocytoscopy before and after treatment
Date of disclosure of the study information 2021/08/10
Last modified on 2024/02/13 10:21:36

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Basic information

Public title

Evaluation of the usefulness of endocytoscopy for diagnosis of gastric MALT lymphoma before and after treatment

Acronym

MALTEC study

Scientific Title

Study of usefulness of diagnosis of MALT lymphoma using endocytoscopy before and after treatment

Scientific Title:Acronym

MALTEC study

Region

Japan


Condition

Condition

Gastric MALT lymphoma

Classification by specialty

Gastroenterology Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate diagnostic ability of endocytoscopic images in vivo to the histological grade of gastric MALT lymphoma

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Diagnostic accuracy of endocytoscopic images by 3 doctors who don't perform endocytoscopy (all images and biopsy)

Key secondary outcomes

1:Sensitivity, specificity, positive predictive value, negative predictive value of biopsy with endocytoscopy.
2:Accuracy, sensitivity, specificity, positive predictive value, negative predictive value of biopsy with endocytoscopy by whom perform endocytoscopy.
3:Accuracy of diagnosis of magnified encoscopy.
4:Concordance rate of diagnosis using images of endocytoscopy and magnified endoscopy by three doctors who don't perform endocytoscopy
5:Correlation of numbers of cells and glands in images by using endocytoscopy and magnified endoscopy
6:Cor0relation of numbers of cells and glands in images between endocytoscopy and histopathology.

*We define ECM3 and Wotherspoon grade 4-5 as existing MALT lymphoma.
*We difine ECM1 and GELA pMRD and ChR as remission of MALT lymphoma.


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

Patients before treatment of MALT lymphoma and who is scheduled detailed examination and biopsy or patients after initial treatment of MALT lymphoma and who is scheduled detailed examination and biopsy.
Patients who are explained adequately about this research and can understand enough and assume and agree by patient's free will.

Key exclusion criteria

Patients that performing endocytoscopy affect after examination and treatment.
Patients who have allergy of methylene blue or crystal violet.
Patients who are forbidden biopsy.
Patients whom researcher estimates inadequate for this research.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Shoko
Middle name
Last name Ono

Organization

Hokkaido University Hospital

Division name

Division of Endoscopy

Zip code

0608648

Address

Kita14, Nishi5, Kita-Ku, Sapporo

TEL

+81-11-716-1161

Email

onosho@med.hokudai.ac.jp


Public contact

Name of contact person

1st name Marina
Middle name
Last name Kubo

Organization

Hokkaido University Hospital

Division name

Division of Endoscopy

Zip code

0608648

Address

Kita14, Nishi5, Kita-Ku, Sapporo

TEL

+81-11-716-1161

Homepage URL


Email

marina.2kb.83@gmail.com


Sponsor or person

Institute

Division of Endoscopy, Hokkaido University Hospital

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethical Review Board for Life Science and Medical Research, Hokkaido University Hospital

Address

Kita14, Nishi5, Kita-Ku, Sapporo, Hokkaido, Japan

Tel

+81-11-716-1161

Email

crjimu@huhp.hokudai.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

2021 Year 08 Month 10 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

Open public recruiting

Date of protocol fixation

2021 Year 01 Month 05 Day

Date of IRB

2021 Year 01 Month 28 Day

Anticipated trial start date

2021 Year 01 Month 28 Day

Last follow-up date

2026 Year 09 Month 30 Day

Date of closure to data entry

2026 Year 09 Month 30 Day

Date trial data considered complete


Date analysis concluded

2026 Year 09 Month 30 Day


Other

Other related information

nothing particular


Management information

Registered date

2021 Year 08 Month 05 Day

Last modified on

2024 Year 02 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049512


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name