UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053402 |
|---|---|
| Receipt number | R000060946 |
| Scientific Title | A study on the clinical features of Oligometastasis in extensive stage small cell lung cancer. |
| Date of disclosure of the study information | 2024/02/10 |
| Last modified on | 2024/01/21 09:53:22 |
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Basic information
Public title
A study on the clinical features of Oligometastasis in extensive stage small cell lung cancer.
Acronym
HOT2301
Scientific Title
A study on the clinical features of Oligometastasis in extensive stage small cell lung cancer.
Scientific Title:Acronym
HOT2301
Region
| Japan |
Condition
Condition
small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Investigating the clinical presentation of oligometastasis in small cell lung cancer.
Basic objectives2
Others
Basic objectives -Others
Examine the relationship between Oligometastasis and patient prognosis.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency of synchronous oligometastasis and origoprogression in small cell lung cancer.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Patients with pathologically diagnosed small cell lung cancer (Neuro endocrine carcinoma (NEC) is excluded).
(2) Patients aged 20 years or over at the time of obtaining consent.
(iii) Patients receiving ICI+platinum combination chemotherapy as initial treatment, or as 1st line treatment after chemoradiotherapy for LD-SCLC or after relapse following radical surgery.
(iv) No refusal of participation in this study by the research subjects themselves or by a person who is considered to be able to represent the will of the research subjects.
Key exclusion criteria
(1) Patients who underwent surgery prior to induction of first-line chemotherapy and received ICI + platinum combination therapy as adjuvant therapy.
(2) Patients who are judged to be inappropriate as research subjects by the principal investigator.
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Hajime |
| Middle name | |
| Last name | Asahina |
Organization
National Hospital Organization Hokkaido Cancer Center
Division name
Department of Respiratory Medicine
Zip code
003-0804
Address
4-2-3-54, Kikusui, Shiroishi-ku, Sapporo
TEL
011-811-9111
asahinah@pop.med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Kana |
| Middle name | |
| Last name | Hashimoto |
Organization
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Division name
Department of Thoracic Oncology and Respiratory Medicine
Zip code
113-8677
Address
3-18-22, Honkomagome, Bunkyo-ku, Tokyo
TEL
03-3823-4890
Homepage URL
kana.hashimo@gmail.com
Sponsor or person
Institute
National Hospital Organization Hokkaido Cancer Center
Institute
Department
Personal name
Funding Source
Organization
nothing
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
Ethical Review Board for Life Science and Medical Research, Hokkaido University Hospital
Address
14-5, Kita-ku, Sapporo, Hokkaido
Tel
011-706-7636
crjimu@huhp.hokudai.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
| 2024 | Year | 02 | Month | 10 | 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
265
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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 03 | Month | 14 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 14 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 15 | Day |
Last follow-up date
| 2024 | Year | 01 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Clinical and imaging information is collected retrospectively from each centre to examine the extent to which patients correspond to oligometastasis.
Management information
Registered date
| 2024 | Year | 01 | Month | 21 | Day |
Last modified on
| 2024 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060946
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
