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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000024256 |
Receipt No. | R000027926 |
Scientific Title | Examination of mechanism and the skin physiology change regarding the anti-inflammation action of minocycline in the skin disorders of the epithelium growth factor receptor inhibitor |
Date of disclosure of the study information | 2016/10/03 |
Last modified on | 2018/11/07 |
Basic information | ||
Public title | Examination of mechanism and the skin physiology change regarding the anti-inflammation action of minocycline in the skin disorders of the epithelium growth factor receptor inhibitor
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Acronym | Examination of mechanism and the skin physiology change regarding the anti-inflammation action of minocycline in the skin disorders of the epithelium growth factor receptor inhibitor | |
Scientific Title | Examination of mechanism and the skin physiology change regarding the anti-inflammation action of minocycline in the skin disorders of the epithelium growth factor receptor inhibitor
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Scientific Title:Acronym | Examination of mechanism and the skin physiology change regarding the anti-inflammation action of minocycline in the skin disorders of the epithelium growth factor receptor inhibitor | |
Region |
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Condition | ||||
Condition | Lung cancer(adenocarcinoma)
Skin disorder(acneiform eruption) |
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Classification by specialty |
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Classification by malignancy | Malignancy | |||
Genomic information | NO |
Objectives | |
Narrative objectives1 | Others |
Basic objectives2 | Others |
Basic objectives -Others | For EGFR gene-positive progress lungs adenocarcinoma, We examine mechanism and a skin physiologic change for the dermatopathy (acneiform eruption) to develop in Japanese in a treatment example frequently in the EGFR-TKI first time.
We examine the mechanism of the anti-inflammatory effect on dermatopathy of EGFR-TKI of the minocycline in addition. |
Trial characteristics_1 | Exploratory |
Trial characteristics_2 | Explanatory |
Developmental phase | Not applicable |
Assessment | |
Primary outcomes | Examination of the mechanism of the anti-inflammatory effect of the minocycline and the pathophysiology of the dermatopathy of EGFR-TKI in biopsy specimens |
Key secondary outcomes | Examination of biomarker of the dermatopathy by a skin physiologic change.
Quantification of cytokine and severity(CTCAE ver.4) of the anti-inflammatory effect of the minocycline. Safety after the minocycline internal use. Examination of an effect of EGFR-TKI and skin toxicity. |
Base | |
Study type | Interventional |
Study design | |
Basic design | Single arm |
Randomization | Non-randomized |
Randomization unit | |
Blinding | Open -no one is blinded |
Control | Self control |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment | No need to know |
Intervention | ||
No. of arms | 1 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | We plan participation registration of 20 cases to check the condition of a patient of the dermatopathy of EGFR-TKI which is end-point and the mechanism of the anti-inflammatory effect of the minocycline and do it with up to five years for the study period.
It is a test method, but the moisturizing agent starts use at the same time from the EGFR-TKI starting date.We measure a water content of the stratum, quantity of sebum and TEWL (transepidermal water loss), pH, skin apparatus measurement(1st) and perform tape stripping before start of therapy in skin biopsy(1st)( H.E. staining, immunohistochemical staining of inflammatory cytokine and quantification). We add external preparation of the steroid by Grade1 (G1) appearance of the acneiform eruption(CTCAE.ver4.). We perform skin biopsy(2nd) and above-mentioned skin apparatus measurement(2nd) and tape stripping when drug eruption turned worse in Grade2 (G2) and start minocycline internal use more. We perform skin biopsy(3rd) and above-mentioned skin apparatus measurement(3rd) and tape stripping after minocycline internal use two weeks later. When acneiform eruption does not reach G2, We perform skin biopsy(2nd) and above-mentioned skin apparatus measurement(2nd) and tape stripping as of four weeks later. Within a follow-up period, We do not perform biopsy, the skin apparatus measurement afterwards even if acneiform eruption becomes G2. We assume it only follow-up. When acneiform eruption reaches G3, the skin biopsy and the above-mentioned skin apparatus measurement and tape stripping cancel the final examination after the third minocycline internal use two weeks later without performing them and introduce to dermatologist. In addition, We are limited to a complier about the skin biopsy. At the time of each medical examination, We evaluate the QOL using Skindex-16 which area skin disease standard, subjective symptoms, objective symptoms and these inspection items. |
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Interventions/Control_2 | ||
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Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1)The patient whom the diagnosis of the pulmonary adenocarcinoma established pathologically.
2) It is confirmed from an organization specimen by an insurance approved method to be EGFR gene variation-positive(exon19 deletion, exon21 L858R variation). 3) In an EGFR-TKI untreated recurrence, progress example, is, a dosage planned patient of gefitinib,erlotinib or afatinib. 4) ECOG performance status 0-1. 5)A main organ (marrow, heart, the lungs, the liver, kidney,etc) does not have a high obstacle. Specifically, as for the marrow function, there are not obstacles more than grade3. As for the cardiac function, the liver function, the renal function, there are not obstacles more than grade2.As the breathing function does not have a interstitial pneumonia and there are not obstacles more than grade2. 6)20 years old or older, the sex does not matter. 7) After enough explanation of examination contents was carried out before final examination registration, a written agreement is provided from a patient. |
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Key exclusion criteria | 1)The patient with history of the EGFR inhibitor treatment.
2)The patient who applied steroid ointment and retinoid or a drug having retinoid-like action to the skin part that was measurement subject within two weeks before clinical trial start. 3)The patient who takes steroid and the minocycline internal use. 4)Complications of a wide range of skin or the patient who has the past. (burn, psoriasis, scleroderma etc.) 5)The patient who received drug-caused skin eruption within two weeks before clinical trial start. 6)A patient with the past of sensitivity to heparin resemblance material component preparation. 7)A patient with hemorrhagic blood disorder(hemophilia, more than grade3 thrombocytopenia, purpura) 8)The patient that it is expected that a few bleeding causes a serious result. 9)A case having serious complications(liver damages more than grade2, renal damage etc.). 10)The patient who internal use is difficult, and has severe diarrhea (more than grade2). 11)The patient with overlap cancer of the activity. 12)A nursing girl and the patient who may be pregnant. The patient who judges that a clinical study doctor (clinical study responsibility doctor,) is inadequate for reasons of others. |
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Target sample size | 20 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Wakayama medical university | ||||||
Division name | Third department of internal medicine,Oncology center | ||||||
Zip code | |||||||
Address | Kimiidera 811-1,Wakayama city, Wakayama, in Japan | ||||||
TEL | 073-447-2300 | ||||||
cshimono@wakayama-med.ac.jp |
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Name of contact person |
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Organization | Wakayama medical university | ||||||
Division name | Third department of internal medicine,Oncology center | ||||||
Zip code | |||||||
Address | Kimiidera 811-1,Wakayama city, Wakayama, in Japan | ||||||
TEL | 073-447-2300 | ||||||
Homepage URL | |||||||
cshimono@wakayama-med.ac.jp |
Sponsor | |
Institute | Wakayama medical university
Third department of internal medicine,Oncology center |
Institute | |
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Funding Source | |
Organization | None |
Organization | |
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Category of Funding Organization | Self funding |
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Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
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IND to MHLW |
Institutions | |
Institutions | 和歌山県立医科大学附属病院/Wakayama medical university hospital |
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Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
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Recruitment status | Completed | ||||||
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027926 |
Research Plan | |
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Research case data specifications | |
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Research case data | |
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