UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040929 |
|---|---|
| Receipt number | R000046735 |
| Scientific Title | Multi center prospective study of indeterminate pulmonary nodule (IPN) detected by computed tomography before primary resection of clinical stage I-III colorectal cancer |
| Date of disclosure of the study information | 2020/06/28 |
| Last modified on | 2023/01/03 06:33:30 |
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Basic information
Public title
Multi center prospective study of indeterminate pulmonary nodule (IPN) detected by computed tomography before primary resection of clinical stage I-III colorectal cancer
Acronym
Prospective study of IPN
Scientific Title
Multi center prospective study of indeterminate pulmonary nodule (IPN) detected by computed tomography before primary resection of clinical stage I-III colorectal cancer
Scientific Title:Acronym
Prospective study of IPN
Region
| Japan |
Condition
Condition
colorectal cancer
Classification by specialty
| Pneumology | Gastrointestinal surgery | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Find out pulmonary metastasis rate of colorectal cancer in IPN
Basic objectives2
Others
Basic objectives -Others
Verification of diagnostic accuracy of IPN in colorectal cancer
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pulmonary metastasis rate
Key secondary outcomes
Follow-up time until diagnosis of metastasis
False positive rate
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)Age:>=20 years old
2)Histologically confirmed colorectal cancer adenocarcinoma, clinical stage I - III
3)R0 resection for primary lesion is planned for initial treatment
4)IPN detected by CT but difficult to get a sample or diagnose by image finding
5)Written informed consent
Key exclusion criteria
1) History of other carcinoma within 5 years
2) Multiple cancer
3) cStage IV
4) Clinically possible to diagnose benignancy and malignancy by physician
5) Other conditions judged ineligible by physician
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Manabu |
| Middle name | |
| Last name | Shiozawa |
Organization
Kanagawa Cancer Center
Division name
Department of Gastrointestinal Surgery
Zip code
241-8515
Address
2-3-2 Nakao, Asahi-ku, Yokohama, JAPAN
TEL
045-520-2222
shiozawam@kcch.jp
Public contact
Name of contact person
| 1st name | Mamoru |
| Middle name | |
| Last name | Uchiyama |
Organization
Kanagawa Cancer Center
Division name
Department of Gastrointestinal Surgery
Zip code
241-8515
Address
2-3-2 Nakao, Asahi-ku, Yokohama, JAPAN
TEL
045-520-2222
Homepage URL
m.uchiyama@kcch.jp
Sponsor or person
Institute
Kanagawa Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Kanagawa Cancer Center
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
Kanagawa Cancer Center
Address
2-3-2, Nakao, Asahi-ku, Yokohama, Kanagawa
Tel
045-520-2222
chiken-jimu4@kcch.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
神奈川県立がんセンター（神奈川県）
横浜市立大学附属病院（神奈川県）
横浜南共済病院（神奈川県）
藤沢湘南台病院（神奈川県）
平塚共済病院（神奈川県）
秦野赤十字病院（神奈川県）
済生会横浜市南部病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 06 | Month | 28 | 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
| 2020 | Year | 04 | Month | 20 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 28 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Risk stratification of pulmonary metastasis in IPN
Management information
Registered date
| 2020 | Year | 06 | Month | 28 | Day |
Last modified on
| 2023 | Year | 01 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046735
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