UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051612 |
|---|---|
| Receipt number | R000058463 |
| Scientific Title | Prognosis of patients with small cell lung carcinoma with or without interstitial pneumonia treated with postoperative adjuvant chemotherapy: A retrospective study |
| Date of disclosure of the study information | 2023/07/15 |
| Last modified on | 2023/07/14 11:58:38 |
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Basic information
Public title
Prognosis of patients with small cell lung cancer with or without interstitial pneumonia treated with postoperative adjuvant chemotherapy: A retrospective study
Acronym
Prognosis of patients with SCLC with or without IP treated with postoperative adjuvant chemotherapy
Scientific Title
Prognosis of patients with small cell lung carcinoma with or without interstitial pneumonia treated with postoperative adjuvant chemotherapy: A retrospective study
Scientific Title:Acronym
Prognosis of patients with SCLC with or without IP treated with postoperative adjuvant chemotherapy
Region
| Japan |
Condition
Condition
Small Cell Lung Cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This retrospective study aims to assess prognosis of small cell cancer treated with postoperative chemotherapy with or without interstitial pneumonia.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The 3-year overall survival rate
Key secondary outcomes
3-year disease-free survival rate, overall survival, disease-free survival, frequency of adverse events, frequency and severity of treatment-related acute exacerbations of interstitial pneumonia.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Treated with surgery and adjuvant chemotherapy for small cell lung cancer.
2. Chemotherapy was started between April 1, 2011, and September 30, 2021.
3. patients who received platinum agent plus etoposide as postoperative chemotherapy.
Key exclusion criteria
1. Patient who received chemoradiotherapy as postoperative treatment.
2. Patient who had not been treated with postoperative adjuvant chemotherapy.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Takuji |
| Middle name | |
| Last name | Suzuki |
Organization
Chiba University Hospital
Division name
Department of Respirology
Zip code
260-8677
Address
1-8-1, Inohana, Chuo-ku, Chiba city, Chiba
TEL
043-222-7171
suzutaku@chiba-u.jp
Public contact
Name of contact person
| 1st name | Mikihito |
| Middle name | |
| Last name | Saito |
Organization
Chiba University Hospital
Division name
Department of Respirology
Zip code
260-8677
Address
1-8-1, Inohana, Chuo-ku, Chiba city, Chiba
TEL
043-222-7171
Homepage URL
https://www.ho.chiba-u.ac.jp/hosp/assets/dl/information/202304_optout_HK202303-14.pdf
saitomikihito@chiba-u.jp
Sponsor or person
Institute
Chiba University Hospital
Institute
Department
Personal name
Funding Source
Organization
Chiba University Hospital
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
Ethics Committee for Observational Studies of Chiba University Hospital
Address
1-8-1, Inohana, Chuo-ku, Chiba city, Chiba
Tel
043-222-7171
hsp-kansaturinri@chiba-u.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
| 2023 | Year | 07 | Month | 15 | 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
| 2023 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 27 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 04 | Month | 11 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2023 | Year | 07 | Month | 14 | Day |
Last modified on
| 2023 | Year | 07 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058463
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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