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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033655
Receipt No. R000036235
Official scientific title of the study 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 2018/08/08

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Basic information
Official scientific title of the study Prospective observational study utilizing Next Generation Sequencing (NGS)-based gene panel including homologous recombination deficiency in patients with unresectable or recurrent pancreatic cancer
Title of the study (Brief title) 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 Masashi Kanai
Organization Kyoto University Hospital
Division name Department of Medical Oncology,
Address 54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto
TEL 075-751-4349
Email kondot@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person Tomohiro Kondo
Organization Kyoto University Hospital
Division name Department of Medical Oncology,
Address 54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto
TEL 075-751-4349
Homepage URL
Email kondot@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University
Institute
Department

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)

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

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2018 Year 02 Month 01 Day
Anticipated trial start date
2018 Year 08 Month 03 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
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
2018 Year 08 Month 08 Day


Link to view the page
URL(English) https://upload.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


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