UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053045 |
|---|---|
| Receipt number | R000060520 |
| Scientific Title | Prospective study of biomarkers and pharmacological characteristics for patients with metastatic lung tumors |
| Date of disclosure of the study information | 2023/12/09 |
| Last modified on | 2023/12/09 18:06:30 |
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Basic information
Public title
Prospective study of biomarkers and pharmacological characteristics for patients with metastatic lung tumors
Acronym
Prospective study of biomarkers and pharmacological characteristics for patients with metastatic lung tumors
Scientific Title
Prospective study of biomarkers and pharmacological characteristics for patients with metastatic lung tumors
Scientific Title:Acronym
Prospective study of biomarkers and pharmacological characteristics for patients with metastatic lung tumors
Region
| Japan |
Condition
Condition
metastatic lung tumor
Classification by specialty
| Pneumology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The goal of this study is to provide personalized medicine for patients with metastatic lung tumors. Since the results of these analyses must be obtained while the patient is alive, efficient and reliable organoid culture is essential. The purpose of this study is to collect data to enable the effective use of metastatic lung tumor organoids. Specifically, we will examine the establishment rate and duration of organoids established on a portion of samples collected from patients with metastatic lung tumors at Keio University Hospital through surgery, search for effective mediums, and drug sensitivity testing to see if we can obtain useful data for future anticancer drug therapy. The purpose of this study is to verify whether we can obtain useful data for future anti-cancer drug therapy.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Organoid establishment efficiency by primary tumor
1) Organoid establishment rate: Percentage of patients with metastatic lung tumor organoids cultured for a minimum of 6 spitzes per primary tumor, using metastatic lung tumor organoid cultures as the denominator.
2) Organoid establishment period: The period from the start date of metastatic lung tumor organoid culture to the date when at least 6 spits of organoids were frozen and cultured for each primary tumor.
Drug sensitivity of organoids per primary tumor
Drug efficacy evaluation of cytotoxic anticancer drugs such as platinum (cisplatin), antimetabolites (fluorouracil), and microvascular inhibitors (docetaxel, paclitaxel), and functional analysis of therapeutic target molecules will be performed in vitro or in vivo.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients who have undergone surgery or undergone bronchoscopy, thoracoscopy, mediastinoscopy, percutaneous needle biopsy, thoracentesis, peritoneal tap, pericardiocentesis, lymph node biopsy, or nasal ablation for the treatment or diagnosis of metastatic lung tumor at Department of Respiratory Surgery and Department of Respiratory Medicine, Keio University Hospital.
2) Informed consent has been obtained in writing from the patient for participation in the study.
3) Informed consent has been obtained from a surrogate if the patient (adult) is incapable of consenting.
Key exclusion criteria
Patients who are deemed by the principal investigator or subinvestigator to be inappropriate to conduct this study.
Target sample size
550
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Yasuda |
Organization
Keio University Hospital
Division name
Internal medicine (respiratory)
Zip code
1600016
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
0333531211
seiji880611@gmail.com
Public contact
Name of contact person
| 1st name | Seiji |
| Middle name | |
| Last name | Omura |
Organization
Keio University Hospital
Division name
Surgery (respiratory)
Zip code
1600016
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
0333531211
Homepage URL
seiji880611@gmail.com
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Keio 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
Keio University Hospital
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
Tel
0333531211
seiji880611@gmail.com
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 | 12 | Month | 09 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 11 | Month | 02 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 02 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 02 | Day |
Last follow-up date
| 2030 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
If the patient also consents to this study before surgery or examination, new samples of metastatic lung tumors collected (including samples obtained by blood sampling, bronchoscopy, percutaneous needle biopsy, thoracentesis, pericardiocentesis, nasal abrasion, etc.), medical information such as medical history, imaging, blood, physiological tests and previously collected samples (paraffin block and medical examination information, etc.) New samples should be collected for diagnostic and therapeutic purposes. New samples are those collected for diagnostic or therapeutic purposes and after they have been used for diagnostic purposes. A portion of the obtained tissue is cultured (cancer cell line culture or organoid culture) to histopathologically examine the biological characteristics of individual tumors. For example, DNA, RNA, proteins, and biological molecules are extracted or tissue samples are prepared, and the expression patterns, expression levels, and concentrations of genes and molecules expressed in cancer cells are analyzed. In addition, we will establish a co-culture system of cancer cells and immune cells from patients and evaluate the efficacy and safety of drugs.
Management information
Registered date
| 2023 | Year | 12 | Month | 09 | Day |
Last modified on
| 2023 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060520
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