UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005131 |
|---|---|
| Receipt number | R000006091 |
| Scientific Title | Prospective study for correlation between disease progression and detection of T790M in plasma DNA using MBP-QP method in non-small cell lung cancer patients treated with EGFR tyrosine kinase inhibitors |
| Date of disclosure of the study information | 2011/03/01 |
| Last modified on | 2019/03/06 10:06:39 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Prospective study for correlation between disease progression and detection of T790M in plasma DNA using MBP-QP method in non-small cell lung cancer patients treated with EGFR tyrosine kinase inhibitors
Acronym
Prospective study for correlation between disease progression and T790M detection in plasma DNA in non-small cell lung cancer (HASAT study)
Scientific Title
Prospective study for correlation between disease progression and detection of T790M in plasma DNA using MBP-QP method in non-small cell lung cancer patients treated with EGFR tyrosine kinase inhibitors
Scientific Title:Acronym
Prospective study for correlation between disease progression and T790M detection in plasma DNA in non-small cell lung cancer (HASAT study)
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The purpose of this prospective study is to determine whether disease progression and detection of T790M in plasma DNA are correlated in non-small lung cancer patients. This is observational study.
Basic objectives2
Others
Basic objectives -Others
The study is to determine the usefulness of T790M detection using the assay system.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The population of patients with presence of T790M in plasma DNA among those who acquired resistance to EGFR-TKI is calculated.
Key secondary outcomes
The concordance of T790M in plasma DNA and those in cancer tissues or effusions are evaluated. The serial analysis of T790M in plasma DNA and anti-tumor effect of EGFR-TKI are also examined.
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
1. Non-small cell lung cancer patients with EGFR activating mutations such as exon 19 deletion and L858R.
2. Non-small cell lung cancer patients with lesions which can be evaluated by RECIST (Version 1.1).
3. Non-small cell lung cancer patients with written consent.
Key exclusion criteria
1. Non-small cell lung cancer patients with EGFR mutations which is related with acquired resistance such as T790M.
2. Non-small cell lung cancer patients who is not appropriated for the study determined by physician in charge.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shunichi Negoro, Shinya Kimura |
Organization
Hyogo Cancer Center,
Saga Univ, Faculty of Medicine
Division name
Dept. of Medical Oncology,
Zip code
Address
13-70, Kitaoji-cyo, Akashi, Hyogo, 673-8558
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoko Aragane |
Organization
Hanshin-Saga Collaborative Cancer Study Group
Division name
Division of Hematology, Respiratory Medicine and Oncology, Faculty of Medicine, Saga Univ.
Zip code
Address
5-1-1 Nabeshima, Saga, 849-8501
TEL
0952-34-2369
Homepage URL
sueokan@cc.saga-u.ac.jp
Sponsor or person
Institute
Foundation for Biomedical Research and Innovation
Institute
Department
Personal name
Funding Source
Organization
Foundation for Biomedical Research and Innovation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
兵庫県立がんセンター（兵庫県）Hyogo Cancer Center
先端医療センター（兵庫県）Foundation for Biomedical Research and Innovation
神戸大学医学部（兵庫県）Kobe Univ. Graduate School of Medicine
刀根山病院（大阪府）Toneyama National Hospital
佐賀県立病院好生館（佐賀県）Saga Prefectural Hospital Koseikan
佐賀大学医学部（佐賀県）Faculty of Medicine, Saga Univ.
山口宇部医療センター（山口県）National Hospital Organization Yamaguchi-Ube Medical Center
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1111/cas.12847
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
| 2010 | Year | 12 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The population of patients with presence of T790M in plasma DNA among those who acquired resistance to EGFR-TKI is calculated.
The concordance of T790M in plasma DNA and those in cancer tissues or effusions are evaluated. The serial analysis of T790M in plasma DNA and anti-tumor effect of EGFR-TKI are also examined.
Management information
Registered date
| 2011 | Year | 02 | Month | 24 | Day |
Last modified on
| 2019 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006091
