UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035975
Receipt number R000040974
Scientific Title Analysis of clinical significance of procalcitonin in small-cell lung cancer
Date of disclosure of the study information 2019/02/22
Last modified on 2021/02/23 14:16:59

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Basic information

Public title

Analysis of clinical significance of procalcitonin in small-cell lung cancer

Acronym

Procalcitonin in SCLC

Scientific Title

Analysis of clinical significance of procalcitonin in small-cell lung cancer

Scientific Title:Acronym

Procalcitonin in SCLC

Region

Japan


Condition

Condition

Small cell lung cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To assess clinical significance of procalcitonin in small-cell lung cancer.

Basic objectives2

Others

Basic objectives -Others

Observational study

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Association between the concentration of procalcitonin and overall survival in small cell lung cancer patients.

Key secondary outcomes

1. Association between the concentration of procalcitonin and response rate, progression-free survival in small cell lung cancer patients.
2. Association between the concentration of procalcitonin and bacterial infection.


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

19 years-old <

Age-upper limit

99 years-old >

Gender

Male and Female

Key inclusion criteria

Patients who receive chemotherapy and/or radiotherapy for small cell lung cancer in Niigata University Medical and Dental Hospital.

Key exclusion criteria

N/A

Target sample size

35


Research contact person

Name of lead principal investigator

1st name Satoshi
Middle name
Last name Watanabe

Organization

Niigata University Medical and Dental Hospital

Division name

Department of Respiratory Medicine and Infectious Diseases

Zip code

951-8510

Address

1-754 Asahimachidori, Chuouku, Niigata, Japan

TEL

0253689325

Email

satoshi7@med.niigata-u.ac.jp


Public contact

Name of contact person

1st name Satoshi
Middle name
Last name Watanabe

Organization

Niigata University Medical and Dental Hospital

Division name

Department of Respiratory Medicine and Infectious Diseases

Zip code

951-8520

Address

1-754 Asahimachidori, Chuouku, Niigata, Japan

TEL

0253689325

Homepage URL


Email

satoshi7@med.niigata-u.ac.jp


Sponsor or person

Institute

Niigata University

Institute

Department

Personal name



Funding Source

Organization

Niigata University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Institutional Review Board of the Niigata University

Address

1-757, Asahimachidori, Chuouku, Niigata, Japan

Tel

025-368-9325

Email

sanonao@adm.niigata-u.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

2019 Year 02 Month 22 Day


Related information

URL releasing protocol

N/A

Publication of results

Unpublished


Result

URL related to results and publications

N/A

Number of participants that the trial has enrolled

79

Results

Twenty-three SCLC patients and 26 NSCLC patients were enrolled as the discovery cohort, and 30 SCLC patients were enrolled as the validation cohort. The PCT level in SCLC patients was significantly higher than that in NSCLC patients. In both the discovery and validation cohorts, the median survival time was significantly shorter in SCLC patients with PCT-high than in SCLC patients with PCT-normal (discovery; 11.7 months vs. 89.7 months, p < 0.005, validation; 9.6 months vs. 22.6 months, p < 0.005).

Results date posted

2021 Year 02 Month 23 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Patients who were pathologically diagnosed with SCLC and NSCLC at our institution.

Participant flow

We used our official institutional website as an opt-out method for the discovery cohort. Patients in the validation cohort provided written informed consent.

Adverse events

N/A

Outcome measures

Serum procalcitonin, survival time

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Enrolling by invitation

Date of protocol fixation

2012 Year 01 Month 20 Day

Date of IRB

2012 Year 02 Month 06 Day

Anticipated trial start date

2012 Year 02 Month 06 Day

Last follow-up date

2014 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

To assess the association between the concentration of procalcitonin and survival time in small cell lung cancer patietns.


Management information

Registered date

2019 Year 02 Month 22 Day

Last modified on

2021 Year 02 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040974


Research Plan
Registered date File name
2020/08/24 プロカルシトニン研究計画.docx

Research case data specifications
Registered date File name
2020/08/24 プロカルシトニン患者説明文書.docx

Research case data
Registered date File name
2020/08/24 プロカルシトニン同意書.doc