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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000004467
Receipt No. R000005345
Scientific Title Evaluation of reproducibility for a biomarker as the prediction of prognosis after radiotherapy for the patients with cervical cancer
Date of disclosure of the study information 2010/11/01
Last modified on 2014/10/27

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Basic information
Public title Evaluation of reproducibility for a biomarker as the prediction of prognosis after radiotherapy for the patients with cervical cancer
Acronym A biomarker as prediction of prognosis after radiotherapy
Scientific Title Evaluation of reproducibility for a biomarker as the prediction of prognosis after radiotherapy for the patients with cervical cancer
Scientific Title:Acronym A biomarker as prediction of prognosis after radiotherapy
Region
Japan

Condition
Condition Cervical cancer
Classification by specialty
Radiology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 This study is prospective, multicentre trial to determine the pretreatment serum Apolipoprotein C-II (ApoC-II) level as a generally applicable measurement in predicting the radiation treatment outcome of patients with cervical carcinoma.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Progression-free survival
Key secondary outcomes Overall survival
Pelvic progression-free survival
Distant metastasis-free survival

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control Uncontrolled
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Gene
Interventions/Control_1 High ApoC-II group (>14.8micro g/mL) when the ApoC-II cut-off point was set at 14.8micro g/mL.
Interventions/Control_2 Low ApoC-II group (<14.8micro g/mL) when the ApoC-II cut-off point was set at 14.8micro g/mL.
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
85 years-old >=
Gender Female
Key inclusion criteria 1. The patient with histologically confirmed primary squamous cell carcinoma of the cervix uteri.
2. The patient with FIGO stage Ib-IVa (in 1994).
3. The patient with ECOG Performance Status (PS) of 0-2.
4. The patient aged between 20 and 85 years at the time of enrollment.
5. The patient without para-aortic lymph node metastasis.
6. The patient without a history of radiation therapy, chemotherapy, or surgical treatment for cervical cancer.
7. The patient who signed a written informed consent after thorough explanation and understanding of protocol requirements.
Key exclusion criteria 1. The patient with cervical stump carcinoma.
2. The patient with active multiple primary cancer defined as synchronous multiple primary cancer and metachronous multiple cancer within 5 years of disease free survival. However, carcinoma in situ judged to be cured by local treatment is not to be included in multiple primary cancer.
3. The patient is pregnant, at risk of pregnancy, or lactating.
4. The patient wishing to become pregnant.
5. The patient with problems which would preclude participation in the study due to a complication of mental diseases or psychiatric symptoms.
6. The patient with serious complications (collagen diseases or uncontrollable diabetes) judged to hinder implementation of treatment.
7. The patient with chronic heart failure or a history of cardiovascular disease within the past 3 months.
8. The patient with a history of serious cerebrovascular disorder within the past 3 months.
9. The patient with active infection.
10. The patient with a pacemaker.
11. The patient with a positive HBsAg.
12. Other patients who were judged as being inappropriate as subjects for this study by investigator.
Target sample size 150

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Yoko Harima
Organization Kansai Medical University, Takii Hospital
Division name Department of Radiology
Zip code
Address 10-15, Fumizono-cho, Moriguchi City, Osaka, Japan
TEL 06-6992-1001
Email harima@takii.kmu.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Yoko Harima
Organization Kansai Medical University, Takii Hospital
Division name Department of Radiology
Zip code
Address 10-15, Fumizono-cho, Moriguchi City, Osaka, Japan
TEL 06-6992-1001
Homepage URL
Email harima@takii.kmu.ac.jp

Sponsor
Institute Department of Radiology, Kansai Medical University, Takii Hospital
Institute
Department

Funding Source
Organization Grant-in-Aid for Scientific Research (B), 2010-2012
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor JROSG
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 関西医科大学附属滝井病院(大阪府)、群馬大学(群馬県)、群馬大学重粒子線医学研究センター(群馬県)、琉球大学(沖縄県)、静岡県立静岡がんセンター(静岡県)、放射線医学総合研究所重粒子医科学センター病院(千葉県)、広島大学(広島県)、北里大学(神奈川県)、聖マリアンナ医科大学(神奈川県)、埼玉県立がんセンター(埼玉県)、佐賀大学(佐賀県)、徳島大学(徳島県)

Other administrative information
Date of disclosure of the study information
2010 Year 11 Month 01 Day

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 No longer recruiting
Date of protocol fixation
2011 Year 12 Month 21 Day
Date of IRB
Anticipated trial start date
2012 Year 04 Month 01 Day
Last follow-up date
2015 Year 09 Month 30 Day
Date of closure to data entry
2015 Year 09 Month 30 Day
Date trial data considered complete
2015 Year 09 Month 30 Day
Date analysis concluded
2015 Year 10 Month 30 Day

Other
Other related information

Management information
Registered date
2010 Year 10 Month 27 Day
Last modified on
2014 Year 10 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005345

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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