UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033655 |
|---|---|
| Receipt number | R000036235 |
| Scientific Title | Prospective observational study utilizing Next Generation Sequencing (NGS)-based gene panel including homologous recombination deficiency in patients with unresectable or recurrent pancreatic cancer |
| Date of disclosure of the study information | 2018/08/08 |
| Last modified on | 2024/02/10 15:30:43 |
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Basic information
Public title
Prospective observational study utilizing Next Generation Sequencing (NGS)-based gene panel including homologous recombination deficiency in patients with unresectable or recurrent pancreatic cancer
Acronym
Prospective observational study utilizing Next Generation Sequencing (NGS)-based gene panel including homologous recombination deficiency in patients with unresectable or recurrent pancreatic cancer
Scientific Title
Prospective observational study utilizing Next Generation Sequencing (NGS)-based gene panel including homologous recombination deficiency in patients with unresectable or recurrent pancreatic cancer
Scientific Title:Acronym
Prospective observational study utilizing Next Generation Sequencing (NGS)-based gene panel including homologous recombination deficiency in patients with unresectable or recurrent pancreatic cancer
Region
| Japan |
Condition
Condition
pancreatic cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate association between the efficacy of oxaliplatin-based chemotherapy and homologous recombination deficiency in patients with unresectable or recurrent pancreatic cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate 1-year survival rate in patients with homologous recombination deficiency who received oxaliplatin based chemotherapy.
Key secondary outcomes
To evaluate clinical outcome, the frequency of homologous recombination deficiency, success rate of clinical sequencing.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Histological or cytologically proved pancreatic cancer adenocarcinoma or adenosquamous carcinoma. Inoperative cases of advanced pancreatic cancer.
2.Written informed consent to participate in this study
3.Age >/=20 years old
4.ECOG Performance Status 0-2
5.Patients with enough specimen to evaluate homologous recombination deficiency.
6.Patients are planned to conducted chemotherapy or currently being conducted chemotherapy.
7.Meets the following criteria within 28 days before enrollment
absolute neutrophil: >1500/mm3
hemoglobin: >8.0 g/dL excluding patients who received blood transfusions within 28 days before the laboratory test
platelet count: >75000/mm3
total bilirubin: <3.0 X ULN
AST and ALT: <2.5 X ULN, <5.0 X ULN with biliary drainage
Creatinine clearance >/=30 mL/min estimated by Cockcroft-Gault formula
Key exclusion criteria
1.Active pulmonary fibrosis or Interstitial pneumonia
2.Having treatment history of platinum-based chemotherapy
3.Severe comorbidities (such as heart failure, renal failure, hepatic failure, paresis of intestine, illeus, poorly controlled diabetes and poorly controlled hypertension)
4.Moderate/severe pleural effusion or ascites
5.Female during pregnancy, within postparturition, or during lactation and male expecting partner's pregnancy.
6.Synchronous or metachronous (within 5 years) malignancies.
7.Patients whose participation in the trial is judged to be inappropriate by the doctor
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Masashi |
| Middle name | |
| Last name | Kanai |
Organization
Kyoto University Hospital
Division name
Department of Medical Oncology,
Zip code
6068307
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto
TEL
075-751-4349
kondot@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | Kondo |
Organization
Kyoto University Hospital
Division name
Department of Medical Oncology,
Zip code
6068307
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto
TEL
075-751-4349
Homepage URL
kondot@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN
Tel
075-753-4680
ethcom@kuhp.kyoto-u.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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 08 | Month | 08 | Day |
Related information
URL releasing protocol
https://link.springer.com/article/10.1007/s12032-023-02011-y
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s12032-023-02011-y
Number of participants that the trial has enrolled
40
Results
The 1yr-OS% after initiation of oxaliplatin-based chemotherapy was 44.4%.
Results date posted
| 2024 | Year | 02 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Forty patients were enrolled
Participant flow
The NGS success rate was 95% (38/40). HRRv was detected in 11 patients (27.5%).
Adverse events
Adverse events are not included in this study.
Outcome measures
1yr-OS%
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 14 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 03 | Day |
Last follow-up date
| 2021 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To evaluate 1-year survival rate in patients with homologous recombination deficiency who received oxaliplatin based chemotherapy.
Management information
Registered date
| 2018 | Year | 08 | Month | 07 | Day |
Last modified on
| 2024 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036235
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
| 2021/08/31 | HRR膵がんデータ固定用横並び.xlsx |
