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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Enrolling by invitation |
Unique ID issued by UMIN | UMIN000040043 |
Receipt No. | R000045617 |
Scientific Title | A case series study of bevacizumab-associated fistula formation in cervical cancer patients. |
Date of disclosure of the study information | 2020/04/24 |
Last modified on | 2020/04/03 |
Basic information | ||
Public title | A case series study of bevacizumab-associated fistula formation in cervical cancer patients. | |
Acronym | A case series study of bevacizumab-associated fistula formation in cervical cancer patients. | |
Scientific Title | A case series study of bevacizumab-associated fistula formation in cervical cancer patients. | |
Scientific Title:Acronym | A case series study of bevacizumab-associated fistula formation in cervical cancer patients. | |
Region |
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Condition | ||
Condition | Advanced or recurrent cervical cancer | |
Classification by specialty |
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Classification by malignancy | Malignancy | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To provide safety information associated with bevacizumab treatment in cervical cancer. |
Basic objectives2 | Safety |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Characteristics and prior treatments of patients who developed fistulas after administration of bevacizumab. |
Key secondary outcomes |
Base | |
Study type | Others,meta-analysis etc |
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 |
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Age-upper limit |
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Gender | Female | |||
Key inclusion criteria | 6 patients who developed fistulas during Avastin Special Drug Use Surveillance (advanced or recurrent cervical cancer) conducted between June 2016 and January 2018. | |||
Key exclusion criteria | None | |||
Target sample size | 6 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | St. Mary's Hospital | ||||||
Division name | Department of Obstetrics and Gynecology | ||||||
Zip code | 830-8543 | ||||||
Address | 422 Tsubukuhonmachi, Kurume,Fukuoka 830-8543,Japan | ||||||
TEL | 0942-35-3322 | ||||||
to-sugiyama@st-mary-med.or.jp |
Public contact | |||||||
Name of contact person |
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Organization | Medical Affairs Div. | ||||||
Division name | Medical Science Dept. | ||||||
Zip code | 103-8324 | ||||||
Address | 1-1 Nihonbashi-Muromachi 2-Chome, Chuo-ku,Tokyo 103-8324,Japan | ||||||
TEL | 03-3273-0866 | ||||||
Homepage URL | |||||||
cma-clinicaltrial@chugai-pharm.co.jp |
Sponsor | |
Institute | St. Mary's Hospital and Chugai Pharmaceutical Co., Ltd. |
Institute | |
Department |
Funding Source | |
Organization | Chugai Pharmaceutical Co., Ltd. |
Organization | |
Division | |
Category of Funding Organization | Profit organization |
Nationality of Funding Organization | Japan |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | Non-profit organization MINS |
Address | 15-14 dogenzaka 1-Chome,shibuya-ku,tokyo,Japan |
Tel | 03-6416-1868 |
Npo-mins@j-irb.com |
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 | |
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 | Enrolling by invitation | ||||||
Date of protocol fixation |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information | Case series study |
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=R000045617 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |