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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000001686 |
Receipt No. | R000002033 |
Scientific Title | The explorative clinical trial of a HPV therapeutic vaccine using lactobacillus to Cervical Intraepithelial Neoplasia 3 (CIN3). |
Date of disclosure of the study information | 2009/02/06 |
Last modified on | 2013/11/07 |
Basic information | ||
Public title | The explorative clinical trial of a HPV therapeutic vaccine using lactobacillus to Cervical Intraepithelial Neoplasia 3 (CIN3). | |
Acronym | The explorative clinical trial of a HPV therapeutic vaccine using lactobacillus to CIN3. | |
Scientific Title | The explorative clinical trial of a HPV therapeutic vaccine using lactobacillus to Cervical Intraepithelial Neoplasia 3 (CIN3). | |
Scientific Title:Acronym | The explorative clinical trial of a HPV therapeutic vaccine using lactobacillus to CIN3. | |
Region |
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Condition | ||
Condition | Cervical Intraepithelial Neoplasia 3 (CIN3) | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | It aims at the first drug therapy to CIN3 by inducing the mucosal cellular immunity to HPV oncoprotein E7 with the oral vaccine using lactobacillus. In this research, it aims to confirm safety and effectiveness of this therapeutic HPV vaccine. |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Clinical safety and efficacy |
Key secondary outcomes |
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 |
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Interventions/Control_1 | The therapeutic HPV vaccine will be taken in 20 days (1st to 5th, 8th to 12th, 22nd to 26th and 50th to 54th day) within all administering period (8 weeks). The dosage is assumed to be 1 to 6 capsule/time/a day. | ||
Interventions/Control_2 | |||
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Interventions/Control_9 | |||
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Female | |||
Key inclusion criteria | 1) HPV16 infected women
2) whom can observe all lesioned part by colposcopic inspection 3) whom hope for conization of the cervix by patients judged that conization of the cervix is necessary 4) whom of 20 ~ 50 years old when agreement is acquired. 5) outpatient 6) All patients were required to provide written informed consent. |
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Key exclusion criteria | 1) Person who has obviously received prohibition of using together medicine (treatment) that causes person and immune suppression that has disease that abnormality is found in immune function
2) patients of class5 in cervical cytology. 3) whom hope for laser ablation 4) patients with serious acute illness 5) patients that there are previous histories of hypersensitivity in lactobacillus content food (yogurt etc.) and preparation of lactobacillus 6) patients who has allergy for milk 7) pregnant or expected to be pregnant 8) breast feeding mother 9) whom administered other trial drugs within three months before initiation of this trial study 10) whom administered this medicine 11) whom the investigator think inappropriate as a candidate. |
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Target sample size | 17 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | The University of Tokyo Hospital | ||||||
Division name | Department of Obstetrics & Gynecology | ||||||
Zip code | |||||||
Address | 7-3-1 Hongo, Bunkyo-ku, Tokyo | ||||||
TEL | |||||||
Public contact | |||||||
Name of contact person |
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Organization | The University of Tokyo Hospital | ||||||
Division name | Department of Obstetrics & Gynecology | ||||||
Zip code | |||||||
Address | 7-3-1 Hongo, Bunkyo-ku, Tokyo | ||||||
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Homepage URL | |||||||
Sponsor | |
Institute | The University of Tokyo Hospital
Department of Obstetrics & Gynecology |
Institute | |
Department |
Funding Source | |
Organization | GENOLAC BL Corp. |
Organization | |
Division | |
Category of Funding Organization | Profit organization |
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IRB Contact (For public release) | |
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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 |
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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 | |
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Baseline Characteristics | |
Participant flow | |
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Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
Date of protocol fixation |
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Date analysis concluded |
Other | |
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Management information | |||||||
Registered date |
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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=R000002033 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |