UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055762 |
|---|---|
| Receipt number | R000063639 |
| Scientific Title | A Multicenter, Retrospective Study on the Risk of Non-Lung Cancer Death after Lobectomy and Sublobar Resection in Lung Cancer Patients |
| Date of disclosure of the study information | 2024/10/07 |
| Last modified on | 2024/10/07 16:05:47 |
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Basic information
Public title
A Multicenter, Retrospective Study on the Risk of Non-Lung Cancer Death after Lobectomy and Sublobar Resection in Lung Cancer Patients
Acronym
Risk of Non-Lung Cancer Death and Surgical Procedure
Scientific Title
A Multicenter, Retrospective Study on the Risk of Non-Lung Cancer Death after Lobectomy and Sublobar Resection in Lung Cancer Patients
Scientific Title:Acronym
Risk of Non-Lung Cancer Death and Surgical Procedure
Region
| Japan |
Condition
Condition
Lung cancer
Classification by specialty
| Chest surgery | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine whether there is an association between surgical procedure and the risk of death from other causes by retrospectively collecting data from multiple institutions on patients who have undergone curative resection for clinical stage I (7th edition) primary lung cancer and have not experienced recurrence of the primary disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Overall survival
Key secondary outcomes
Event-free survival by cause of death,overall survival by patient background factors
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients aged 18 years or older at the time of surgery who underwent complete resection for clinical stage IA or IB (TNM classification, 7th edition) primary lung cancer (or suspected) between January 1, 2013 and December 31, 2013.
2) Patients with a final pathological diagnosis of primary lung cancer (including small cell lung cancer).
3) Patients who have undergone lobectomy, segmentectomy (up to 4 segments, including subsegmentectomy), or partial resection.
4) Patients who have not been found to have a recurrence of the disease (or death from the disease).
Key exclusion criteria
1) Patients with a history of lung resection (including benign diseases).
2) Patients who have undergone preoperative treatment (drug therapy, radiation therapy, or chemoradiotherapy).
3) Patients who have undergone resection of more than one lobe (lobectomy + partial resection, lobectomy + segmentectomy, bi-lobectomy, pneumonectomy, etc.).
4) Patients who have undergone partial resection or segmentectomy of two or more separate parts of the lung.
5) Patients who have undergone bronchoplasty, vascularplasty, and combined resection of surrounding organs (chest wall, pericardium, etc.).
6) Patients who died within 30 days of surgery or died in hospital within 90 days of surgery.
7) Patients who refused to participate in the study.
8) Patients whom the investigator deems ineligible for any reason.
Target sample size
8000
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Nakao |
Organization
Cancer Institute Hospital, Japanese Foundation for Cancer Research
Division name
Department of Thoracic Surgical Oncology
Zip code
135-8550
Address
Cancer Institute Hospital, 3-8-31 Ariake, Koto-ku, Tokyo, Japan
TEL
0335200111
masayuki.nakao@jfcr.or.jp
Public contact
Name of contact person
| 1st name | Masyauki |
| Middle name | |
| Last name | Nakao |
Organization
Cancer Institute Hospital, Japanese Foundation for Cancer Research
Division name
Department of Thoracic Surgical Oncology
Zip code
135-0062
Address
Cancer Institute Hospital, 3-8-31 Ariake, Koto-ku, Tokyo, Japan
TEL
0335200111
Homepage URL
masayuki.nakao@jfcr.or.jp
Sponsor or person
Institute
Japanese Foundation for Cancer Research
Institute
Department
Personal name
Funding Source
Organization
The Japanese Association for Chest Surgery
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Cancer Institute Hospital, Japanese Foundation for Cancer Research
Address
3-8-31 Ariake, Koto-ku, Tokyo, Japan
Tel
0335200111
med.shinsa@jfcr.or.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
がん研究会有明病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 10 | Month | 07 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 22 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 22 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2026 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
| 2027 | Year | 12 | Month | 31 | Day |
Other
Other related information
A Multicenter, Retrospective Study
Management information
Registered date
| 2024 | Year | 10 | Month | 07 | Day |
Last modified on
| 2024 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063639
