Differential diagnosis of pancreatic cancer and chronic pancreatitis with serum miR-25

• Register: ChiCTR
• Last refreshed on: 28 September 2020
• Main ID: ChiCTR2000037002
• Date of registration: 2020-08-26
• Prospective Registration: Yes
• Primary sponsor: The First Affiliated Hospital of the Naval Medical University of the Chinese People's Liberation Army
• Public title: Differential diagnosis of pancreatic cancer and chronic pancreatitis with serum miR-25
• Scientific title: A prospective study of serum miR-25 detection in differential diagnosis of pancreatic cancer and chronic pancreatitis
• Date of first enrolment: 2020-10-01
• Target sample size: Target condition:150;Difficult condition:150
• Recruitment status: Pending
• URL: http://www.chictr.org.cn/showproj.aspx?proj=60021
• Study type: Diagnostic test
• Study design: Factorial
• Phase: 0

Countries of recruitment

China

Contacts

• Name: Liu Wenyu
• Affiliation: The First Affiliated Hospital of the Naval Medical University of the Chinese People's Liberation Army

• Name: Liu Wenyu
• Affiliation: The First Affiliated Hospital of the Naval Medical University of the Chinese People's Liberation Army

Key inclusion & exclusion criteria

Inclusion criteria: Patients diagnosed as pancreatic cancer and chronic pancreatitis in the Department of Hepatobiliary Pancreatic and Splenic Surgery and the Department of Gastroenterology in our hospital from October 2020 to June 2022 were included in the study strictly according to the inclusion criteria.
Study group:
(1) 18-75 years old, male or female.
(2) Pancreatic ductal adenocarcinoma originating from pancreatic ductal epithelium was confirmed by pathological examination (operative biopsy, puncture biopsy, cytological examination). Pancreatic ductal adenocarcinoma was highly suspected to be pancreatic cancer by clinical diagnosis before (pancreatic ductal adenocarcinoma, PDAC), and patients with pancreatic ductal adenocarcinoma diagnosed by surgical biopsy and blood collection before operation could be enrolled in the group.
(3) before blood collection, the patient did not receive surgical treatment.
(4) before blood collection, the patient had not received systematic antineoplastic drugs (Systematic Anti-tumor Therapy), including long-acting growth inhibitor analogues, interferon, PRRT (peptide receptor radionuclide therapy), mTOR inhibitors and chemotherapy, etc.
(5) before blood collection, the patient did not receive radiotherapy or neoadjuvant therapy.
(6) sign the informed consent form for research.

Control group:
(1) 18-75 years old, male or female.
(2) patients who are clinically diagnosed as chronic pancreatitis and have no evidence to support the diagnosis of pancreatic cancer.
(3) Blood samples were collected before admission.
(4) sign the informed consent form for research.
Exclusion criteria: (1) the subjects were in the stage of acute infection.
(2) the subjects had been treated or taken drugs before blood collection.
(3) failed to join the group or refused to follow up for various reasons.

Age minimum: 18
Age maximum: 75
Gender: Both

Health Condition(s) or Problem(s) studied

pancreatic cancer

Intervention(s)

Gold Standard:Pancreatic cancer: pancreatic ductal adenocarcinoma originating from pancreatic ductal epithelium was confirmed by pathological examination (operative biopsy, puncture biopsy, cytological examination). Chronic pancreatitis: Clinically diagnosed as chronic pancreatitis, and no evidence to support the diagnosis of pancreatic cancer.;Index test:Serum miR-25;

Primary Outcome(s)

pancreatic cancer;SEN, SPE, ACC, AUC of ROC;

Source(s) of Monetary Support

Self-financing

Ethics review

Status: Approved
Approval date: 24/08/2020
Contact:

Liao Zhuan