UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062848 |
|---|---|
| Receipt number | R000071948 |
| Scientific Title | A retrospective study of High-VAF FANCD2 variants and oncogenic drivers in non-small cell lung cancer. |
| Date of disclosure of the study information | 2026/09/08 |
| Last modified on | 2026/09/08 16:50:46 |
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Basic information
Public title
A retrospective study of High-VAF FANCD2 variants and oncogenic drivers in non-small cell lung cancer.
Acronym
Retrospective study of FANCD2 variants and oncogenic drivers in non-small cell lung cancer
Scientific Title
A retrospective study of High-VAF FANCD2 variants and oncogenic drivers in non-small cell lung cancer.
Scientific Title:Acronym
A retrospective study of High-VAF FANCD2 variants and oncogenic drivers in non-small cell lung cancer.
Region
| Japan |
Condition
Condition
Non-Small Cell Lung Cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To determine the oncogenic driver positivity in patients with NSCLC harboring high-VAF FANCD2 variants (VAF>=40%) using institutional tumor-only CGP data, and to exploratorily compare it with those without FANCD2 variants.
Basic objectives2
Others
Basic objectives -Others
To evaluate the driver-positive proportion in the low-VAF FANCD2 group (VAF<40%).
To describe the FANCD2 variants, VAFs, co-occurring driver alterations, and clinicopathologic characteristics of high-VAF FANCD2 cases.
To characterize the concordance or discordance of tumor driver alterations in familial cases, including first-degree relatives sharing the identical FANCD2 variant.
To exploratorily describe the co-occurrence of high-VAF variants and driver oncogenes across other panel-sequenced genes using the same VAF threshold (>=40%).
To perform sensitivity analyses excluding either member of the parent-child pair to account for their biological non-independence.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The proportion of patients harboring oncogenic drivers in the high-VAF FANCD2 group, and comparison with FANCD2-negative patients
Key secondary outcomes
Proportion of driver-positive cases in the low-VAF FANCD2 group
Proportion of driver-positive cases in the overall FANCD2-positive group (high- and low-VAF combined)
Details of driver alteration types and FANCD2 variants in high-VAF FANCD2 cases
Characterization of the shared FANCD2 variant and discordant driver fusions in the parent-child pair
Proportion of driver positivity across genes harboring high-VAF variants other than FANCD2
Co-occurrence of high-VAF variants and oncogenic drivers within Fanconi anemia and homologous recombination repair pathway gene
Sensitivity analysis accounting for biological non-independence within the family
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
Patients diagnosed with NSCLC at our institution during the study period.
Patients who underwent CGP using OCA v3 or OCA Plus as part of routine clinical care and whose analysis results are evaluable.
Patients whose minimum required clinical data can be retrieved from medical records.
Key exclusion criteria
Patients who underwent CGP exclusively for tumors other than NSCLC.
Patients whose genomic alterations, such as gene mutations or fusions, are substantially uninterpretable due to inadequate specimen quality or other technical reasons.
Patients who declined to participate in the study via opt-out, either by themselves or through their proxies.
Patients deemed inappropriate for analysis by the principal investigator due to compromised data quality (reasons to be documented).
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | Kentarou |
| Middle name | |
| Last name | Ito |
Organization
Saiseikai Matsusaka Municipal Hospital
Division name
Respiratory Center
Zip code
5150073
Address
1550, Tonomachi, Matsusaka city, Mie
TEL
0598231515
kentarou_i_0214@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Kentaro |
| Middle name | |
| Last name | Ito |
Organization
Saiszeikai Matsusaka Municipal Hospital
Division name
Respiratory Center
Zip code
5150073
Address
1550, Tonomachi, Matsusaka, Mie
TEL
0598231515
Homepage URL
kentarou_i_0214@yahoo.co.jp
Sponsor or person
Institute
Saiseikai Matsusaka Municipal Hospital
Institute
Department
Personal name
Kentaro Ito
Funding Source
Organization
Nothing
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saiseikai Matsusaka Municipal Hospital
Address
1550, Tonomachi, Matsusaka, Mie
Tel
0598231515
kentarou_i_0214@yahoo.co.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 | 09 | Month | 08 | 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
74
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
| 2026 | Year | 08 | Month | 12 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 21 | Day |
Anticipated trial start date
| 2026 | Year | 08 | Month | 21 | Day |
Last follow-up date
| 2026 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Nothing
Management information
Registered date
| 2026 | Year | 09 | Month | 08 | Day |
Last modified on
| 2026 | Year | 09 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071948
