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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042893
Receipt No. R000048962
Scientific Title prognostic analysis of non-small cell lung cancer patients with pathological stage II-IIIB
Date of disclosure of the study information 2021/01/05
Last modified on 2021/01/04

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Basic information
Public title prognostic analysis of non-small cell lung cancer patients with pathological stage II-IIIB
Acronym prognostic analysis of non-small cell lung cancer patients with pathological stage II-IIIB
Scientific Title prognostic analysis of non-small cell lung cancer patients with pathological stage II-IIIB
Scientific Title:Acronym prognostic analysis of non-small cell lung cancer patients with pathological stage II-IIIB
Region
Japan

Condition
Condition Non-small cell lung cancer
Classification by specialty
Pneumology Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To determine the prognostic value of cisplatin unfit in postoperative lung cancer patients with stage II-III pathology requiring cisplatin-based adjuvant chemotherapy
Basic objectives2 Others
Basic objectives -Others Reasons why standard postoperative adjuvant chemotherapy could not be administered and alternative treatments
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Overall survival by postoperative adjuvant therapy
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
90 years-old >
Gender Male and Female
Key inclusion criteria patients who underwent surgery for non-small cell lung cancer between 2010 and 2020, patients with pathological stage II-IIIB requiring postoperative adjuvant chemotherapy as standard treatment will be included.
Key exclusion criteria Non-complete resection cases
Target sample size 500

Research contact person
Name of lead principal investigator
1st name Toyofumi Fengshi
Middle name
Last name Chen-Yoshikawa
Organization Nagoya University
Division name Graduate School of Medicine, Department of Thoracic Surgery
Zip code 4668550
Address 65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, JAPAN
TEL 0527442375
Email tyoshikawa@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name Shota
Middle name
Last name Nakamura
Organization Nagoya University
Division name Graduate School of Medicine, Department of Thoracic Surgery
Zip code 4668550
Address 65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, JAPAN
TEL 0527442375
Homepage URL
Email shota197065@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University
Institute
Department

Funding Source
Organization Nagoya University
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 Nagoya university hospital
Address 65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
Tel 0527442375
Email shota197065@med.nagoya-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
2021 Year 01 Month 05 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 Preinitiation
Date of protocol fixation
2021 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2021 Year 02 Month 01 Day
Last follow-up date
2022 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information retrospective observational study

Management information
Registered date
2021 Year 01 Month 04 Day
Last modified on
2021 Year 01 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048962

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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