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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT1040230091

Enrollment

180

Registered

2023-10-17

Start date

2023-09-05

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 pancreatic cancer

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: (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.

Exclusion criteria

Exclusion criteria: (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.

Design outcomes

Primary

Measure	Time frame
Quantification of ptDNA by ddPCR and evaluation of its negativity by systemic chemotherapy and its usefulness as a biomarker	—

Secondary

Measure	Time frame
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.	—

Contacts

Public ContactHaruyoshi Tanaka

University of Toyama

tanakaharu@med.nagoya-u.ac.jp+81-76-434-7331

Outcome results