UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026019 |
|---|---|
| Receipt number | R000029530 |
| Scientific Title | Observational study to investigate the execution rate of re-biopsy and the concordance rate for T790M mutation detection by the Cobas test between histological and cytological samples in EGFR-TKI-resistant patients with EGFR mutation-positive advanced non-small cell lung cancer |
| Date of disclosure of the study information | 2017/02/07 |
| Last modified on | 2021/05/10 18:43:56 |
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Basic information
Public title
Observational study to investigate the execution rate of re-biopsy and the concordance rate for T790M mutation detection by the Cobas test between histological and cytological samples in EGFR-TKI-resistant patients with EGFR mutation-positive advanced non-small cell lung cancer
Acronym
Observational study to investigate the execution rate of re-biopsy and the concordance rate for T790M mutation detection by the Cobas test between histological and cytological samples in EGFR-TKI-resistant patients with EGFR mutation-positive advanced non-small cell lung cancer
Scientific Title
Observational study to investigate the execution rate of re-biopsy and the concordance rate for T790M mutation detection by the Cobas test between histological and cytological samples in EGFR-TKI-resistant patients with EGFR mutation-positive advanced non-small cell lung cancer
Scientific Title:Acronym
Observational study to investigate the execution rate of re-biopsy and the concordance rate for T790M mutation detection by the Cobas test between histological and cytological samples in EGFR-TKI-resistant patients with EGFR mutation-positive advanced non-small cell lung cancer
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Execution rate of re-biopsy in secondarily registered patients
Concordance rate for T790M mutation detection by the Cobas test between histological and cytological samples.
Basic objectives2
Others
Basic objectives -Others
Execution rate of re-biopsy in secondarily registered patients
Concordance rate for T790M mutation detection by the Cobas test between histological and cytological samples.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Execution rate of re-biopsy in secondarily registered patients
Concordance rate for T790M mutation detection by the Cobas test between histological and cytological samples.
Key secondary outcomes
Success rate of re-biopsy (= Number of patients with detected cancer cells / Number of re-biopsies performed), Individual test modalities (for bronchoscopy, confirm whether EBUS-TBNA or EBUS-GS has been performed or not) / Positive T790M mutation rate by biopsy site (= Number of patients with positive T790M mutation / Number of patients with detected cancer cells), Safety of individual test modalities, Analysis of reasons for patients not undergoing re-biopsy after secondary registration, Execution rate of re-biopsy by use or non-use of each test modality (e.g., EBUS-TBNA, EBUS-GS, CT-guided biopsy), Investigation of prognosis at 1 year after secondary registration (including the type of subsequent treatment)
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
Primary registration:
1) Histologically or cytologically confirmed non-small cell lung cancer
2) Stage III/IV not amenable to definitive radiation therapy or postoperative recurrence at the start of EGFR-TKI therapy
3) Presence of any EGFR-activating mutation (Exon 19 del, L858R, or uncommon mutation) confirmed by tissue or cell genetic testing before the start of EGFR-TKI therapy
4) Ongoing EGFR-TKI (gefitinib, erlotinib, afatinib) therapy
5) No T790M mutation detected after the start of EGFR-TKI therapy
6) Written informed consent for study participation from the patient
Secondary registration:
1) Sustained response to EGFR-TKI (CR, PR, or SD for>6 weeks)
2) Confirmed (or concerned about) development of resistance to EGFR-TKI
In this study, development of resistance is defined as any of the three conditions below and determined by the treating physician according to the patient's condition:
(i) PD assessed by RECIST
(ii) PD assessed clinically
(iii) SD assessed by RECIST with an increasing tendency of the tumor compared with baseline
Key exclusion criteria
Treatment by 3rd generation EGFR-TKI
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Toshiaki |
| Middle name | |
| Last name | Kikuchi |
Organization
Niigata university graduate school of medicine and dental sciences
Division name
Department of respiratory medicine and infectious disease
Zip code
9518510
Address
1-754 Asahimachi-dori,Chuo-ku,Niigata city
TEL
025-368-9324
kikuchi@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Kenichi |
| Middle name | |
| Last name | Koyama |
Organization
Niigata cancer center hospital
Division name
Department of internal medicine
Zip code
9518566
Address
2-15-3 Kawagishi-cho,Chuo-ku,Niigata city
TEL
025-266-5111
Homepage URL
k-koyama@niigata-cc.jp
Sponsor or person
Institute
Niigata Lung Cancer Treatment Group
Institute
Department
Personal name
Funding Source
Organization
AstraZeneca
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Niigata cancer center hospital
Address
2-15-3 Kawagishi-cho,Chuo-ku,Niigata city
Tel
025-266-5111
k-koide@niigata-cc.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
| 2017 | Year | 02 | Month | 07 | 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
Completed
Date of protocol fixation
| 2017 | Year | 02 | Month | 03 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 09 | Day |
Anticipated trial start date
| 2017 | Year | 02 | Month | 08 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 05 | Month | 31 | Day |
Other
Other related information
Investigational Items at Primary Enrollment
Patient demographic information: Age, sex, Eastern Cooperative Oncology Group - Performance Status (ECOG-PS), history of smoking
Information at diagnosis: Histologic type (adenocarcinoma, squamous cell carcinoma, other carcinomas), clinical stage, testing method used to confirm the diagnosis, EGFR gene mutation status
Information on treatment: History of surgery, postoperative adjuvant chemotherapy, chest irradiation, history of TKI therapy, treatment line
Investigational Items at Secondary Enrollment
Information on treatment: Type of TKI, dose administered, date of first dose, date of last dose, reason for discontinuation, PS at discontinuation, best overall response, dose reduced or not
Information on re-biopsy: Site(s) of exacerbation (primary lesion, intrapulmonary metastasis, pleural effusion, mediastinal lymph node, CNS, adrenal gland, bone, liver, extrathoracic lymph node), the greatest dimension if measurable, number of sites, re-biopsy performed or not, testing method and result if re-biopsy has been performed, complications related to re-biopsy observed or not, reason if re-biopsy has not been performed
The testing method, the reason for not performing re-biopsy, and the test result will be recorded by selecting the respective relevant numbers from the numbers listed the reference document.
For any repeated re-biopsy or re-biopsy requested to a different medical institution, the information for repeated re-biopsy will be entered (In the case of the request from a different medical institution, the doctor in charge requesting re-biopsy must enter the the data.).
Investigation of Prognosis
Subsequent treatment planned or not, the content of the treatment, the effect of the treatment, the duration of the treatment, outcome, the duration of survival
(A form for the investigation of prognosis will be sent to each study site from the administrative office by one year after secondary enrollment)
Management information
Registered date
| 2017 | Year | 02 | Month | 06 | Day |
Last modified on
| 2021 | Year | 05 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029530
