UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032002
Receipt number R000036418
Scientific Title Follicular lymphoma in Japan: a prospective cohort study of newly-diagnosed patients with follicular lymphoma
Date of disclosure of the study information 2018/04/01
Last modified on 2023/05/18 17:50:52

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Basic information

Public title

Follicular lymphoma in Japan: a prospective cohort study of newly-diagnosed patients with follicular lymphoma

Acronym

Follicular lymphoma in Japan: a prospective cohort study of newly-diagnosed patients with follicular lymphoma(FOREST)

Scientific Title

Follicular lymphoma in Japan: a prospective cohort study of newly-diagnosed patients with follicular lymphoma

Scientific Title:Acronym

Follicular lymphoma in Japan: a prospective cohort study of newly-diagnosed patients with follicular lymphoma(FOREST)

Region

Japan


Condition

Condition

Follicular lymphoma

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To elucidate the clinical presentation, pathological classifications, pattern of initial management, and outcomes in patients with newly diagnosed follicular lymphoma in Japan.

Basic objectives2

Others

Basic objectives -Others

Clinical presentation, pathological classifications, pattern of initial management, outcomes

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Overall survival from diagnosis date

Key secondary outcomes



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

1) Newly-diagnosed follicular lymphoma (Grade 1, 2, 3A, and 3B).
2) Treatment or follow-up is being scheduled at a participating hospital.
3) Aged 20 or over.
4) Written informed consent.

Key exclusion criteria

1) Past history of any type of malignant lymphoma.
2) Follicular lymphoma with diffuse large B-cell lymphoma.
3) Transformed follicular lymphoma.

Target sample size

1000


Research contact person

Name of lead principal investigator

1st name Koji
Middle name
Last name Izutsu

Organization

National Cancer Center Hospital

Division name

Department of Hematology

Zip code

104-0045

Address

5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan

TEL

03-3542-2511

Email

TRIML1620@tri-kobe.org


Public contact

Name of contact person

1st name Wataru
Middle name
Last name Munakata

Organization

National Cancer Center Hospital

Division name

Department of Hematology

Zip code

104-0045

Address

5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan

TEL

03-3542-2511

Homepage URL


Email

TRIML1620@tri-kobe.org


Sponsor or person

Institute

The Japanese Society for Lymphoreticular Tissue Research(JSLTR)

Institute

Department

Personal name



Funding Source

Organization

Eisai Co., Ltd
Chugai Pharmaceutical Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

National Cancer Center Institutional Review Board

Address

5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan

Tel

03-3542-2511

Email

NCC_IRBoffice@ml.res.ncc.go.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

2018 Year 04 Month 01 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

1120

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

No longer recruiting

Date of protocol fixation

2018 Year 02 Month 14 Day

Date of IRB

2018 Year 02 Month 21 Day

Anticipated trial start date

2018 Year 04 Month 01 Day

Last follow-up date

2028 Year 02 Month 29 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

1)Prospective Cohort study
2)Patients who satisfy selection criteria, do not meet exclusion criteria, and provide written informed consent.
3)the clinical presentation including clinical stage, tumor burden, and prognostic factors, pathological classifications, pattern of initial management, outcomes.


Management information

Registered date

2018 Year 03 Month 30 Day

Last modified on

2023 Year 05 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036418


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name