UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005804
Receipt number R000006843
Scientific Title The predictive value of measuring immature platelet fraction (IPF) in the recovery from thrombocytopenia caused by chemotherapy in lung cancer patients
Date of disclosure of the study information 2011/06/22
Last modified on 2019/02/16 15:40:32

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Basic information

Public title

The predictive value of measuring immature platelet fraction (IPF) in the recovery from thrombocytopenia caused by chemotherapy in lung cancer patients

Acronym

The predictive value of immature platelet fraction (IPF) in the recovery from thrombocytopenia in lung cancer chemotherapy

Scientific Title

The predictive value of measuring immature platelet fraction (IPF) in the recovery from thrombocytopenia caused by chemotherapy in lung cancer patients

Scientific Title:Acronym

The predictive value of immature platelet fraction (IPF) in the recovery from thrombocytopenia in lung cancer chemotherapy

Region

Japan


Condition

Condition

lung cancer

Classification by specialty

Pneumology Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

the usefulness of measuring immmature platelet fraction as the predictive factor for the recovery from thronbocytopenia in lung cancer chemotherapy

Basic objectives2

Others

Basic objectives -Others

the acuracy of predicting to recover from thrombocytopenia

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase



Assessment

Primary outcomes

recovery from thronbocytopenia

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

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

lung cancer patients recieved chemotherapy

Key exclusion criteria

lung cancer patients not recieved chemotherapy

Target sample size

250


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shigeaki Ogura

Organization

Hokkaido Medical Center, Natinal Hospital Organaizetion

Division name

Department of Respirology

Zip code


Address

Yamanote 5-jo 7-chome, Nishi-ku, Sapporo, Hokkaido

TEL

011-611-8111

Email



Public contact

Name of contact person

1st name
Middle name
Last name Shigeaki Ogura

Organization

Hokkaido Medical Center

Division name

Department of Respirology

Zip code


Address

Yamanote 5-jo 7-chome, Nishi-ku, Sapporo, Hokkaido

TEL

011-611-8111

Homepage URL


Email



Sponsor or person

Institute

Hokkaido Medical Center, Natinal Hospital Organaizetion

Institute

Department

Personal name



Funding Source

Organization

Hokkaido Medical Center, Natinal Hospital Organaizetion

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Asahikawa Medical Center, Natinal Hospital Organaizetion

Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

北海道医療センター(北海道)


Other administrative information

Date of disclosure of the study information

2011 Year 06 Month 22 Day


Related information

URL releasing protocol


Publication of results

Partially published


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

2011 Year 05 Month 25 Day

Date of IRB


Anticipated trial start date

2011 Year 05 Month 30 Day

Last follow-up date

2015 Year 03 Month 31 Day

Date of closure to data entry

2015 Year 03 Month 31 Day

Date trial data considered complete

2015 Year 03 Month 31 Day

Date analysis concluded

2015 Year 03 Month 31 Day


Other

Other related information

twice a week, platelet and IPF are measured at least during chemotherapy.
If Grade 3 thrombocytopenia occures, platelet and IPF are measured every two days until the recovery.


Management information

Registered date

2011 Year 06 Month 19 Day

Last modified on

2019 Year 02 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006843


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name