Prospective observational study utilizing Next Generation Sequencing (NGS)-based gene panel including homologous recombination deficiency in patients with unresectable or recurrent pancreatic cancer

Prospective observational study utilizing Next Generation Sequencing (NGS)-based gene panel including homologous recombination deficiency in patients with unresectable or recurrent pancreatic cancer - Prospective observational study utilizing Next Generation Sequencing (NGS)-based gene panel including homologous recombination deficiency in patients with unresectable or recurrent pancreatic cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000033655

Enrollment

Registered

2018-08-08

Start date

2018-08-03

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pancreatic cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
To evaluate 1-year survival rate in patients with homologous recombination deficiency who received oxaliplatin based chemotherapy.	—

Secondary

Measure	Time frame
To evaluate clinical outcome, the frequency of homologous recombination deficiency, success rate of clinical sequencing.	—

Countries

Japan

Contacts

Public ContactTomohiro Kondo

Kyoto University Hospital Department of Medical Oncology,

kondot@kuhp.kyoto-u.ac.jp075-751-4349

Outcome results