PIRAMID study

JRCT ID: jRCT1041230160

Registered date:28/02/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Pancreatic Cancer
• Date of first enrollment: 31/01/2022
• Target sample size: 200
• Study type: Observational

Outcome(s)

• Primary Outcome: Relationship between mR status and risk of local recurrence and life expectancy
• Secondary Outcome: Relationship between mR status and pathological findings, and comparison of local recurrence and prognostic value between mR status and allele frequency of KRAS mutations in cfDNA

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: <= 90age old
• Gender: Both

Include criteria

(1) Patients with pancreatic cancer diagnosed and resected by various imaging and pathological diagnoses between January 1, 2017 and December 31, 2025.
(2) Patients whose prognosis for life is judged to be more than 6 months by the study investigator (3) Patients whose age at the time of enrollment is between 20 and 90 years old
(3) Patients must be between 20 and 90 years of age at the time of enrollment.
(4) Performance status (ECOG) is 0, 1, or 2.
(5) Patients must have undergone first resection for pancreatic cancer.
(6) Consent for participation in this study has been obtained from the patient (For the use of stored specimens (Study No. 2014-0042) collected at Nagoya University Hospital for a different purpose from the study and for which consent for secondary use has already been obtained, please contact the Department of Gastroenterological Surgery, Nagoya University Graduate School of Medicine, and the Department of Gastroenterology, Oncology and General Surgery, Department of Medicine, Faculty of Academic Research, University of Toyama, Nagoya Medical Center, and the opportunity to refuse will be guaranteed by disclosing the information on the website of the Clinical Research Center).

Exclude criteria

(1) Patients whose prognosis for life is judged to be less than 6 months by the study investigator
(ii) Patients with serious (still requiring hospitalization) underlying diseases (cardiac disease, pulmonary disease, intestinal paralysis, intestinal obstruction, diabetes mellitus difficult to control, renal failure, cirrhosis of the liver, etc.)
(iii) Active multiple cancers (simultaneous multiple cancers and iatrogenic multiple cancers with a disease-free period of less than 5 years. (c) Active overlapping cancer (simultaneous overlapping cancer and iatrogenic overlapping cancer with a disease-free period of less than 5 years; however, carcinoma in situ (intraepithelial carcinoma) and intramucosal carcinoma equivalent lesions judged to have been cured by local treatment are not included in active overlapping cancer).
(iv) Patients with psychosis or psychiatric symptoms that would make participation in the study difficult.
(v) Patients who did not give consent to participate in the study
(vi) Other patients who are judged to be inappropriate for this study by the investigator (subinvestigator).

Related Information

• Primary Sponsor: Kodera Yasuhiro
• Source(s) of Monetary Support: Chubu Science and Technology Center