UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061999 |
|---|---|
| Receipt number | R000070587 |
| Scientific Title | Longitudinal assessment of CircuLAting Minimal residual disease in advanced non-small cell lung cancer receiving immune-checkPoint inhibitors: a prospective observational study [CLAMP] (WJOG23325L) |
| Date of disclosure of the study information | 2026/06/26 |
| Last modified on | 2026/06/22 11:35:04 |
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Basic information
Public title
Longitudinal assessment of CircuLAting Minimal residual disease in advanced non-small cell lung cancer receiving immune-checkPoint inhibitors: a prospective observational study [CLAMP] (WJOG23325L)
Acronym
CLAMP
Scientific Title
Longitudinal assessment of CircuLAting Minimal residual disease in advanced non-small cell lung cancer receiving immune-checkPoint inhibitors: a prospective observational study [CLAMP] (WJOG23325L)
Scientific Title:Acronym
CLAMP
Region
| Japan |
Condition
Condition
Advanced NSCLC
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the association between the detection status of minimal residual disease (MRD) using Myriad's tumor-informed assay and prognosis in patients with advanced or recurrent non-small cell lung cancer (NSCLC) scheduled to receive immune checkpoint inhibitors (ICIs).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
- MRD analysis success rates
- MRD positivity and negativity rates
- Progression-free survival (PFS) and 1-year PFS rate according to MRD status (positive vs. negative)
- Overall survival (OS) and 1-year OS rate according to MRD status (positive vs. negative)
- Turnaround time for MRD testing (blinded to treating physicians and patients)
- Frequency of MRD conversion (clearance/emergence)
- PFS, 1-year PFS rate, OS, and 1-year OS rate according to MRD conversion status
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
- Patients with pathologically confirmed non-small cell lung cancer (NSCLC) regardless of PD-L1 expression level
- Absence of actionable driver mutations targetable in the first-line setting, or unknown driver mutation status
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Patients with stage III or IV disease ineligible for curative treatment (surgical resection or definitive radiotherapy), or those with recurrence after surgery or radiotherapy
- No prior systemic therapy for advanced/recurrent disease
- Scheduled to initiate ICI therapy within 4 weeks of registration (initiation on the same day of the week 4 weeks later is acceptable)
- Deemed capable of providing tissue and blood samples for MRD testing by the physician
- Patients with evaluable lesions according to RECIST version 1.1
- Aged 18 years or older at the time of informed consent
- Capable of understanding the study procedures and providing written informed consent personally
Key exclusion criteria
- Patients deemed unsuitable for study participation by the principal investigator or sub-investigator.
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Akamatsu |
Organization
Wakayama Medical University
Division name
Internal Medicine III
Zip code
641-8510
Address
811-1, Kimiidera, Wakayama
TEL
073-441-0619
hiroakiakamatsu@gmail.com
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Ishizuka |
Organization
West Japan Oncology Group
Division name
WJOG datacenter
Zip code
556-0016
Address
Namba Plaza Bldg. 304-1-5-7, Motomachi Naniwa-ku, Osaka 556-0016 JAPAN
TEL
06-6633-7400
Homepage URL
https://www.wjog.jp/
datacenter@wjog.jp
Sponsor or person
Institute
West Japan Oncology Group
Institute
Department
Personal name
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
IRB at Wakayama Medical University
Address
811-1, Kimiidera, Wakayama
Tel
073-441-0619
hiroakiakamatsu@gmail.com
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 | 06 | Month | 26 | 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 | 06 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 10 | Month | 26 | Day |
Last follow-up date
| 2030 | Year | 10 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2026 | Year | 06 | Month | 22 | Day |
Last modified on
| 2026 | Year | 06 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070587
