跳至主要内容
临床试验/jRCT1041230160
jRCT1041230160招募中不适用

Development of diagnostics for pancreatic cancer's molecular resection margin status at dissected peripancreatic tissue margin by margin imprint droplet digital PCR (PIRAMID study)

未提供0 个研究点目标入组 200 人开始时间: 2022年1月31日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
200
主要终点
-

研究概览

简要总结

暂无简介。

研究设计

研究类型
Observational

入排标准

年龄范围
No limit 至 90age old under(—)
性别
All

入选标准

  • (1) Patients with pancreatic cancer diagnosed and resected by various imaging and pathological diagnoses between January 1, 2017 and December 31,
  • (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
  • (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).

排除标准

  • (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).

结局指标

主要结局

-

Relationship between mR status and risk of local recurrence and life expectancy

次要结局

  • Comparison of local recurrence between mR status and allele frequency of KRAS mutations in cfDNA
  • Comparison of prognostic value between mR status and allele frequency of KRAS mutations in cfDNA
  • Relationship between mR status and pathological findings

研究者

发起方
未提供

相似试验

PIRAMID study (PIRAMID study) | 临床试验