UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063340 |
|---|---|
| Receipt number | R000072495 |
| Scientific Title | Uniportal Video-assisted thoracoscopic surgery Assessment for Lung cancer Validity and Efficiency: a multicentre, single-arm, prospective confirmatory study (JUVIG 2601) |
| Date of disclosure of the study information | 2026/10/19 |
| Last modified on | 2026/10/19 16:09:56 |
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Basic information
Public title
Uniportal Video-assisted thoracoscopic surgery Assessment for Lung cancer Validity and Efficiency: a multicentre, single-arm, prospective confirmatory study (JUVIG 2601)
Acronym
Uni-VALVE Study
Scientific Title
Uniportal Video-assisted thoracoscopic surgery Assessment for Lung cancer Validity and Efficiency: a multicentre, single-arm, prospective confirmatory study (JUVIG 2601)
Scientific Title:Acronym
Uni-VALVE Study
Region
| Japan |
Condition
Condition
cStage IA1-2 Non-Small Cell Lung Cancer (NSCLC, cT1a-bN0M0)
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the oncological validity (efficacy) and safety of uniportal video-assisted thoracoscopic anatomical lung resection (lobectomy and segmentectomy) for cStage IA1-2 early-stage non-small cell lung cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
5-year Recurrence-Free Survival (RFS), defined as the time from the secondary registration date to the date of recurrence or death from any cause, whichever occurs first
Key secondary outcomes
Prognostic outcomes: 3-year RFS, 3- and 5-year Overall Survival (OS), 3- and 5-year Disease-Free Survival (DFS), 3- and 5-year Cancer-Specific Survival (CSS), and local recurrence rate.
Surgical feasibility: Rate of conversion to thoracotomy, port addition, and procedure change.
Perioperative safety: Postoperative complication rate (within 30 days), blood loss, blood transfusion, reoperation rate, and operative time.
Postoperative recovery: Duration of chest tube drainage, hospital stay, 30-day readmission rate, and 30-day/90-day mortality.
Curative indicators: Number of dissected lymph nodes, extent of dissection, surgical procedure, and pathological stage.
Exploratory endpoints: Up-staging rate, high-grade histology, EGFR/ALK/PD-L1 status, pulmonary function, and QOL assessments.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Uniportal video-assisted thoracoscopic anatomical lung resection (lobectomy or segmentectomy) using a single incision <= 4 cm, with systematic lymph node dissection (ND1b or higher for cT1a, ND2a-1 or higher for cT1b)
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
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Chest CT within 56 days prior to registration confirming cT1a-bN0M0 Stage IA1-2, deemed resectable by uniportal VATS anatomical lung resection (lobectomy or segmentectomy).
Number of sub-tumors <= 2 (meeting protocol criteria).
All lesions resectable in a single stage (total resection <= 5 segments).
Clinically suspected non-small cell lung cancer (pathological confirmation prior to registration is not mandatory).
Age at registration: 20 to 79 years.
No history of thoracotomy or anatomical lung resection on the ipsilateral side.
No history of radiation therapy involving the ipsilateral hilum or mediastinum.
ECOG Performance Status of 0 or 1.
Adequate organ function for radical resection.
Written informed consent obtained from the patient.
Key exclusion criteria
Active double/multiple primary cancers (synchronous or metachronous within 5 years).
Systemic infection requiring treatment, or fever >= 38 deg C at registration.
Pregnant, possibly pregnant, or lactating women.
Psychiatric disease or symptoms making study participation difficult.
Ongoing systemic administration of corticosteroids or immunosuppressive agents.
Uncontrolled diabetes mellitus or hypertension.
Severe cardiac disease, heart failure, or history of myocardial infarction/angina within 6 months.
Complication of interstitial pneumonia, pulmonary fibrosis, or severe emphysema
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Suda |
Organization
Fujita Health University
Division name
Department of Thoracic Surgery
Zip code
444-0827
Address
1-1 Gotanda, Harisaki-cho, Okazaki, Aichi 444-0827, Japan
TEL
0564-64-8800
suda@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Takahiro |
| Middle name | |
| Last name | Homma |
Organization
St. Marianna University School of Medicine
Division name
Department of Thoracic Surgery
Zip code
216-8511
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki City, Kanagawa 216-8511, Japan
TEL
044-977-8111
Homepage URL
takahiro.homma@marianna-u.ac.jp
Sponsor or person
Institute
Japan Uniportal VATS Interest Group
Institute
Department
Personal name
TAKAHIRO HOMMA
Funding Source
Organization
None
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
St. Marianna University School of Medicine
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki City, Kanagawa 216-8511, Japan
Tel
044-977-8111
takahiro.homma@marianna-u.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
| 2026 | Year | 10 | Month | 19 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 08 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 10 | Month | 23 | Day |
Last follow-up date
| 2036 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 10 | Month | 19 | Day |
Last modified on
| 2026 | Year | 10 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072495
