UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016297 |
|---|---|
| Receipt number | R000018908 |
| Scientific Title | A research on imaging of concentration of drug on the skin rash and normal skin tissue in patients with advanced pancreatic cancer treating with gemcitabine and erlotinib. |
| Date of disclosure of the study information | 2015/01/21 |
| Last modified on | 2019/12/06 13:34:31 |
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Basic information
Public title
A research on imaging of concentration of drug on the skin rash and normal skin tissue in patients with advanced pancreatic cancer treating with gemcitabine and erlotinib.
Acronym
A research on imaging of concentration of drug on the skin rash and normal skin tissue in patients with advanced pancreatic cancer treating with gemcitabine and erlotinib.
Scientific Title
A research on imaging of concentration of drug on the skin rash and normal skin tissue in patients with advanced pancreatic cancer treating with gemcitabine and erlotinib.
Scientific Title:Acronym
A research on imaging of concentration of drug on the skin rash and normal skin tissue in patients with advanced pancreatic cancer treating with gemcitabine and erlotinib.
Region
| Japan |
Condition
Condition
advanced pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
It is not determine a rise of drug concentration of erlotinib to be taken orally on the skin rash tissue.
Basic objectives2
Others
Basic objectives -Others
We verify imaging of a rise of drug concentration of skin tissue of skin rash treating with erlotinib with advanced pancreatic cancer, and also compare with normal skin tissue.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Imaging of drug concentration of erlotinib on the skin tissue
Key secondary outcomes
To compare of imaging of drug concentration on skin rash and normal skin
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Biopsy for all the enrolled subjects
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients with histological or cytological evidence of pancreactic cancer(exclude of neuroendocrine tumor).
Or, cytology is class 4, but clinically diagnosed pancreactic cancer.
2) Unresectable locally advanced or metastatic pancreatic cancer.
3) Patients aged more than 20.
4) Eastern Cooperative Oncology Group performance status of 0, 1
5) Patients treating witn erlotinib.
6) Patients who have adequate hematological, renal and respiratory, heart function.
a) Neutrophil count is more than 500/mm3.
b) Platlet is more than 50000/mm3 on the day of biopsy.
7) Informed consent can obtain from patients.
Key exclusion criteria
1) In cases of difficult to biopsy of normal skin tissue, because of past history of skin disease, for example, atopic dermatitis or collagenosis.
2) Patients with past history of allergy of local anesthetization drug.
3) In cases of doctor judged inappropriate for this protocol.
Target sample size
11
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hironobu Minami |
Organization
Kobe University Hospital
Division name
Department of Medical Oncology and Hematology
Zip code
Address
7-5-2, Kusunokicho, Chuo-ku, Kobe, Hyogo, Japan
TEL
078-382-5111
hminami@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Meiko Nishimura |
Organization
Kobe University Hospital
Division name
Department of Medical Oncology and Hematology
Zip code
Address
7-5-2, Kusunokicho, Chuo-ku, Kobe, Hyogo, Japan
TEL
078-382-5111
Homepage URL
meinishi@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Hospital
Institute
Department
Personal name
Funding Source
Organization
Kobe University Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 01 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/29719624
Number of participants that the trial has enrolled
5
Results
Focal distribution of erlotinib in the skin tissue was visualized using non-labeled MALDI-MSI. Erlotinib concentration in the superficial layer of the skin rashes was higher than that in the adjacent normal skin.
Results date posted
| 2019 | Year | 05 | Month | 09 | Day |
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
| 2013 | Year | 10 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 10 | Month | 28 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective study of determing to imaging of drug concentration on skin tissue.
Management information
Registered date
| 2015 | Year | 01 | Month | 21 | Day |
Last modified on
| 2019 | Year | 12 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018908
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