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

JRCT ID: jRCT1040230091

Registered date:17/10/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Pancreatic cancer
• Date of first enrollment: 05/09/2023
• Target sample size: 180
• Study type: Observational

Outcome(s)

• Primary Outcome: Quantification of ptDNA by ddPCR and evaluation of its negativity by systemic chemotherapy and its usefulness as a biomarker
• Secondary Outcome: 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.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Fujii Tsutomu