UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004467 |
|---|---|
| Receipt number | 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 | 2023/06/14 16:47:35 |
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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
Observational
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
| 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
Name of lead principal investigator
| 1st name | Yoko |
| Middle name | |
| Last name | Harima |
Organization
Kansai Medical University, Takii Hospital
Division name
Department of Radiology
Zip code
570-8507
Address
10-15, Fumizono-cho, Moriguchi City, Osaka, Japan
TEL
06-6992-1001
harima@takii.kmu.ac.jp
Public contact
Name of contact person
| 1st name | Yoko |
| Middle name | |
| Last name | Harima |
Organization
Kansai Medical University, Takii Hospital
Division name
Department of Radiology
Zip code
570-8507
Address
10-15, Fumizono-cho, Moriguchi City, Osaka, Japan
TEL
06-6992-1001
Homepage URL
harima@takii.kmu.ac.jp
Sponsor or person
Institute
Department of Radiology, Kansai Medical University, Takii Hospital
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research (B), 2010-2012
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
JROSG
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Ethics Committee, Kansai Medical University
Address
2-5-1 Shinmachi, Hirakata City, Osaka, Japan
Tel
072-804-0101
rinri@hirakata.kmu.ac.jp
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
. https://doi.org/10.1371/journal. pone.0259235
Publication of results
Published
Result
URL related to results and publications
. https://doi.org/10.1371/journal. pone.0259235
Number of participants that the trial has enrolled
148
Results
Larger tumor size was independently associated with shorter PFS, OS, PPFS, and DMFS. Higher pretreatment (P<0.001) and posttreatment SCC-Ag (P= 0.017) was associated with shorter DMFS. Patients with pretreatment ApoC-II levels < 2 5.8 micro g/ml had shorter PPFS than those with pretreatment ApoC-II levels > 25.8 micro g/ml. pre-and posttreatment serum SCC-Ag and pretreatment serum ApoC-II levels may be important biomarkers to predict survival outcomes of patients with cervical cancer after radiotherapy.
Results date posted
| 2023 | Year | 05 | Month | 31 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 11 | Month | 02 | Day |
Baseline Characteristics
The eligibility criteria included: histologically proven squamous cell carcinoma of the uterine cervix; international Federation of gynecology and Obstetrics (FIGO, 2009) stage IB-IVA; Eastern Cooperative Oncology Group (ECOG) performance status, 0-2; age 20-85 years; no para-aortic lymph node metastasis; no history of radiotherapy, chemotherapy, or surgery for cervical cancer; and written informed consent.
Participant flow
Of 148 enrolled, 3 were excluded before starting the treatment, 1 could not complete definitive radiotherapy, and two transferred to another hospital with less than 1 year of observation. Of 142 analyzed, 98 were alive with no evidence of disease, 23 were alive with progression of disease, 18 were dead, and 3 were lost to follow-up during the observation period.
Adverse events
Adverse events were not evaluated in this study.
Outcome measures
Progression-free survival (PFS) was the primary endpoint, and overall survival (OS), pelvic PFS (PPFS), and
distant metastasis-free survival (DMFS) were the secondary endpoints.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2011 | Year | 12 | Month | 21 | Day |
Date of IRB
| 2012 | Year | 01 | Month | 25 | Day |
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
This is a multicenter prospective cohort study.
Standard radiotherapy was performed on eligible cervical cancer patients who visited participating facilities between March 2012 to July 2016. For cervical cancer patients, 6 mL of venous blood will be collected before radiotherapy and 1 month after the end of treatment, for a total of 12 mL. We extracted apolipoprotein C-II, which is a tumor marker, and SCC antigen values from blood samples, and examined the relationship with prognosis.
Management information
Registered date
| 2010 | Year | 10 | Month | 27 | Day |
Last modified on
| 2023 | Year | 06 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005345
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