臨床研究等提出・公開システム

Accompanying study of a multicenter phase II study to investigate the efficacy of systemic chemotherapy in patients with peritoneal washing cytology-positive potentially curable pancreatic cancer: Validation of quantifying peritoneal tumor DNA during systemic chemotherapy to monitor negative conversion of cancerous cytology and exploration for novel biomarkers of pancreatic cancer. (WALCURE DRIVE)

Validation of quantifying peritoneal tumor DNA during systemic chemotherapy to monitor negative conversion of cancerous cytology and exploration for novel biomarkers of pancreatic cancer. (WALCURE DRIVE)

Fujii Tsutomu

University of Toyama

2630, Sugitani, Toyama

fjt@med.u-toyama.ac.jp

Tanaka Haruyoshi

University of Toyama

2630, Sugitani, Toyama

+81-76-434-7331

tanakaharu@med.nagoya-u.ac.jp

Recruiting

Aug. 22, 2023

Observational

single arm study

open(masking not used)

uncontrolled control

single assignment

diagnostic purpose

(1) Patients must have histologically or cytologically confirmed adenocarcinoma.
(2) Patients must be at least 20 years of age at the time of enrollment.
(3) Patients must have a PS of 0-1.
(4) Patients must not have received any prior therapy (radiation therapy, chemotherapy, immunotherapy, etc.) for the primary disease.
(5) Consent to participate in the main study and this ancillary study has been obtained from the patient.

(1) previous treatment (radiotherapy, chemotherapy, immunotherapy, etc.) has been given for the primary disease.
(2) having undergone resection of the primary tumor.
(3) having obvious infection or inflammation (e.g., fever over 38.0) at the time of study enrollment
(4) having serious complications (requiring hospitalization), such as cardiac disease, intestinal paralysis, intestinal obstruction, interstitial pneumonia or pulmonary fibrosis, diabetes mellitus difficult to control, renal failure, or cirrhosis of the liver.
(5) having a large amount of ascites or pleural effusion.
(6) having a mental disorder that is being treated with antipsychotic drugs or is thought to require treatment, and is unable to understand the explanations given.
(7) Unable to obtain effective informed consent.

Pancreatic cancer

pancreatic cancer

D010190

Quantification of ptDNA by ddPCR and evaluation of its negativity by systemic chemotherapy and its usefulness as a biomarker

The significance of ptDNA as a biomarker compared to circulating tumor DNA (ctDNA) in blood and the search for new predictors of peritoneal metastasis and peritoneal recurrence. To explore the morphological prognostic value of cytology Papanicolaou stained specimen images for peritoneal metastasis and peritoneal recurrence.

+81-76-415-8857

Aug. 22, 2023

Yes

Enrollment will be conducted by the principal investigator at each site, who will verify that study subjects meet the selection criteria and do not meet any of the exclusion criteria at the time of the initial abdominal lavage cytology collection and determine eligibility, and then enroll via the Registration Data Center's EDC (Electrical Data Capture) system (REDCap). The subjects will be enrolled via the Registration Data Center's EDC (Electrical Data Capture) system (REDCap).

none