UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048977 |
|---|---|
| Receipt number | R000055775 |
| Scientific Title | Lung Cancer Genomic Screening Project for Neoadjuvant and Adjuvant setting Molecular Targeted Therapy in Early-Stage Non-Small Cell Lung Cancer and the Assessment of monitoring Minimal Residual Disease |
| Date of disclosure of the study information | 2022/09/23 |
| Last modified on | 2022/09/20 17:00:29 |
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Basic information
Public title
Lung Cancer Genomic Screening Project for Neoadjuvant and Adjuvant setting Molecular Targeted Therapy in Early-Stage Non-Small Cell Lung Cancer and the Assessment of monitoring Minimal Residual Disease
Acronym
LC-SCRUM-Advantage/MRD
Scientific Title
Lung Cancer Genomic Screening Project for Neoadjuvant and Adjuvant setting Molecular Targeted Therapy in Early-Stage Non-Small Cell Lung Cancer and the Assessment of monitoring Minimal Residual Disease
Scientific Title:Acronym
LC-SCRUM-Advantage/MRD
Region
| Japan |
Condition
Condition
Lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To screen any actionable oncogenic drivers in patients with early-stage non-small cell lung cancer (NSCLC) who are candidates for targeted therapy.
Basic objectives2
Others
Basic objectives -Others
To assess the utility of monitoring of Minimal Residual Disease (MRD) as a biomarker to predict recurrence and treatment response in patients with lung cancer.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
To characterize the clinicopathological and molecular biological features of early-stage NSCLC with genetic alterations identified in the genomic screening.
Key secondary outcomes
To assess the utility of monitoring of MRD as a biomarker to predict recurrence and treatment response in patients with lung cancer.
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Advantage-cohorts (Cohort A1)
1) Patients with pathologically (histology or cytology) confirmed NSCLC, clinical stage I, II and III.
2) Treatment-naive and scheduled for surgery for lung cancer
MRD-cohorts (Cohort A2, A3, A4, B1 and B2)
NCCLC (Cohort A2, A3 and A4)
3) Stage I, II and III, scheduled for surgery. (Cohort A2)
4) Stage III, scheduled for CRT. (Cohort A3)
5) Advanced NSCLC, scheduled for Chemotherapy (Cohort A4)
SCLC (B1, B2)
6) LD-SCLC, scheduled for CRT (Cohort B1)
7) ED-SCLC, scheduled for Chemotherapy and enrolled into JCOG2002. (Cohort B2)
The following is common to all cohorts.
8) Patients aged 16 years or older
9) Patients with pathologically (histology or cytology) confirmed lung cancer
10) Eastern Cooperative Oncology Group performance status (PS) of 0 or 1. However, Cohort B2 is also eligible for PS 2.
11) Patients who meet the following criteria for major organ function (assessed by a test performed within 2 weeks prior to study enrollment):
- (1) Neutrophil count: >=1500/mm 3
- (2) Hemoglobin: >=8.0 g/dl
- (3) Platelet count: >=7.5 x 10 4/mm 3
- (4) AST, ALT: <=ULN (upper limit of normal) x 3 (x 5 in patients with liver metastasis)
- (5) Total bilirubin: <=ULN x 1.5
- (6) SpO2: >=90%
12) Patients without serious complications (e.g., interstitial pneumonitis, poorly controlled diabetes mellitus, cardiac disease, infection, etc.)
13) Patients who are expected to live for at least 3 months from the date of study enrollment
14) Patients who are able to submit samples that can be used for genetic analyses. The samples must be ones collected before the initial drug treatment
15) Patients who wish to enroll in genotype-directed clinical trials if the target gene alterations are identified in this study
16) Patients who have provided written consent to enroll in this study
Key exclusion criteria
Not applicable
Target sample size
10680
Research contact person
Name of lead principal investigator
| 1st name | Koichi |
| Middle name | |
| Last name | Goto |
Organization
National Cancer Center Hospital East
Division name
Department of Thoracic Oncology
Zip code
277-8577
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan
TEL
04-7133-1111
kgoto@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | Kiyotaka |
| Middle name | |
| Last name | Yoh |
Organization
National Cancer Center Hospital East
Division name
Department of Thoracic Oncology
Zip code
277-8577
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan
TEL
04-7133-1111
Homepage URL
kyoh@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center
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
National Cancer Center Hospital East
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba
Tel
04-7133-1111
irst@ml.res.ncc.go.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
| 2022 | Year | 09 | Month | 23 | 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
| 2022 | Year | 06 | Month | 16 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 02 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 29 | Day |
Last follow-up date
| 2027 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a prospective observational study.
Management information
Registered date
| 2022 | Year | 09 | Month | 20 | Day |
Last modified on
| 2022 | Year | 09 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055775
