UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016837 |
|---|---|
| Receipt number | R000019517 |
| Scientific Title | Evaluation of Prognostic Impact of Serum Autoantibody in Patients with Metastatic Non-small-Cell Lung Cancer without EGFR activating mutation nor ALK fusion gene |
| Date of disclosure of the study information | 2015/03/20 |
| Last modified on | 2024/09/23 09:45:06 |
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Basic information
Public title
Evaluation of Prognostic Impact of Serum Autoantibody in Patients with Metastatic Non-small-Cell Lung Cancer without EGFR activating mutation nor ALK fusion gene
Acronym
Prognostic Impact of Serum Autoantibody in Metastatic Non-small-Cell Lung Cancer without activating mutations
Scientific Title
Evaluation of Prognostic Impact of Serum Autoantibody in Patients with Metastatic Non-small-Cell Lung Cancer without EGFR activating mutation nor ALK fusion gene
Scientific Title:Acronym
Prognostic Impact of Serum Autoantibody in Metastatic Non-small-Cell Lung Cancer without activating mutations
Region
| Japan |
Condition
Condition
Non-Small-Cell Lung Cancer
Classification by specialty
| Medicine in general | Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the prognostic impact of serum autoantibody (anti-CTLA-4 antibody, anti-PD-1 antibody, anti-BTLA antibody and anti-RPL29 antibody) in patients with metastatic non-small-cell lung cancer without EGFR activating mutation nor ALK fusion gene
Basic objectives2
Others
Basic objectives -Others
To evaluate the association between serum anti-RPL29 antibody levels and overall survival
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The association between serum anti-RPL29 antibody levels and overall survival
Key secondary outcomes
1, The association between serum anti-RPL29 antibody levels and progression-free survival in first-line chemotherapy
2, The association of serum anti-CTLA-4 antibody levels with overall survival or progression-free survival in first-line chemotherapy
3, The association of serum anti-PD-1 antibody levels with overall survival or progression-free survival in first-line chemotherapy
4, The association of serum anti-BTLA antibody levels with overall survival or progression-free survival in first-line chemotherapy
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. Written informed consent
2. Patients aged >= 20 years
3. Pathologically-confirmed non-small-cell lung cancer
4. Stage IV disease (TNM classification, 7th edition)
5. Tumor without activating EGFR mutation (Del19 or L858R) nor ALK fusion gene
6. Standard platinum-containing chemotherapy with or without bevacizumab is scheduled as first-line chemotherapy
7. Performance Status of 0 or 1 (Eastern Cooperative Oncology Group)
8. Adequate organ function
Key exclusion criteria
1. Concomitant other malignancy
2. Life expectancy <= 3 months
3. Use of steroid hormone, immunosuppressant, or biologic drug within 4 weeks at the time of enrollment
4. Severe active infection or poorly controlled disease ( e.g. hypertension, diabetes mellitus, cardiac disorder, gastro-intestinal bleeding, and so on)
5. Pregnant, possibly pregnant or lactating woman
6. Requiring radiation therapy to brain, mediastinum, or lung
7. Concomitant obvious interstitial lung disease on chest computed tomography
8. Poorly controlled malignant effusion requiring drainage
9. Otherwise determined by the investigator or the attending physician to be unsuitable as a subject in this study
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hiroshige |
| Middle name | |
| Last name | Yoshioka |
Organization
Kansai Medical University Hospital
Division name
Dept. of Thoracic Oncology
Zip code
573-1191
Address
2-3-1 Shin-machi, Hirakata, Osaka, Japan
TEL
072-804-0101
hgyoshioka@gmail.com
Public contact
Name of contact person
| 1st name | Hiroshige |
| Middle name | |
| Last name | Yoshioka |
Organization
Kansai Medical University Hospital
Division name
Dept. of Thoracic Oncology
Zip code
573-1191
Address
2-3-1 Shin-machi, Hirakata, Osaka, Japan
TEL
072-804-0101
Homepage URL
hgyoshioka@gmail.com
Sponsor or person
Institute
Dept. of Thoracic Oncology, Kansai Medical University Hospital
Institute
Department
Personal name
Funding Source
Organization
Kurashiki Central 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
Ceter for Ethical Approval, Kansai Medical University
Address
2-5-1 Shin-machi, Hirakata, Osaka, Japan
Tel
072-804-0101
rinriirb@hirakata.kmu.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
倉敷中央病院（岡山県）、静岡県立静岡がんセンター（静岡県）、近畿中央胸部疾患センター（大阪府)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 03 | Month | 20 | Day |
Related information
URL releasing protocol
N/A
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
72
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
The reason of delay is due to temporal halt of measurement of antibodies by the inspection body.
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
Main results already published
Date of protocol fixation
| 2015 | Year | 02 | Month | 25 | Day |
Date of IRB
| 2015 | Year | 02 | Month | 19 | Day |
Anticipated trial start date
| 2015 | Year | 03 | Month | 20 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2024 | Year | 09 | Month | 30 | Day |
Other
Other related information
To evaluate the prognostic impact of serum autoantibody (anti-CTLA-4 antibody, anti-PD-1 antibody, anti-BTLA antibody and anti-RPL29 antibody) in patients with metastatic non-small-cell lung cancer without EGFR activating mutation nor ALK fusion gene: a prospective multicenter registration study.
Management information
Registered date
| 2015 | Year | 03 | Month | 18 | Day |
Last modified on
| 2024 | Year | 09 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019517
