Status:
UNKNOWN
Detection of MicroRNA-25 in the Diagnosis of Pancreatic Cancer
Lead Sponsor:
Fudan University
Conditions:
Carcinoma, Pancreatic Ductal
Eligibility:
All Genders
18+ years
Brief Summary
Pancreatic cancer represents the most lethal of the common malignancies, with a 5-year survival rate of less than 5%. For patients who, when are diagnosed of pancreatic cancer, are eligible for potent...
Detailed Description
Pancreatic cancer (mainly pancreatic ductal adenocarcinoma, PDAC) is a disease with extremely poor prognosis, and is often fatal. Surgical resection is the only potentially curative technique for mana...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Group One:
- Patient aged 18 years old and above at the time of signing the ICF.
- Prior to blood sample withdraw, patient not treated with systematic anti-tumor therapy, including long-acting somatostatin analogues, interferons, PRRT (Peptide Receptor- Radionuclide Therapy), mTOR inhibitors and chemotherapy; not treated with radiotherapy or neo-adjuvant therapies.
- Differences:
- Experiment Subgroup: Patients diagnosed or highly-suspected of pancreatic cancer, among whom:
- Operable: Patients confirmed with pancreatic cancer by pathological test, and evaluated by MDT as "operable" and "probably operable"; Not operable: Patients confirmed with pancreatic cancer by cytological test (exfoliative cytology or fine needle puncture biopsy), or highly suspected of pancreatic cancer by the MDT referring to disease history, clinical manifestations, lab test and imagining results.
- Control Subgroup: Patients confirmed with gallbladder carcinoma, biliary tract lower segment carcinoma, and gastrointestinal carcinoma by pathological test.
- Interference Subgroup: Patients diagnosed of chronic pancreatitis, IPMN (intraductal papillary mucinous neoplasm), SPT (solid pseudopapillary tumor of pancreas), pancreatic cystic adenoma.
- Group Two:
- Patient aged 18 years old and above at the time of signing the ICF, and with an expected survival time of over 12 months.
- Prior to the first blood sample withdraw after surgery, patient not treated with radiotherapy or adjuvant therapy.
- Differences:
- Experiment Subgroup: Patients confirmed of pancreatic cancer and received successful curative operation.
- Control Subgroup: Patients confirmed of gallbladder carcinoma and biliary tract lower segment carcinoma, and received successful curative operation.
- Exclusion Criteria
- Group One:
- Patient in the period of acute infection.
- Patient treated with therapies or drugs prior to blood withdraw.
- Blood sample shows jaundice (TBIL≥17.1μmol/L) and hematolysis (to be decided by the serum sample preparer).
- Blood sample has been stored for one year and above.
- Group Two:
- Patient treated with therapies or drugs prior to first blood withdraw after surgery.
- Patient shows symptoms of remote metases.
- Blood sample shows jaundice (TBIL≥17.1μmol/L) and hematolysis (to be decided by the serum sample preparer).
- Blood sample has been stored for one year and above.
Exclusion
Key Trial Info
Start Date :
March 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2019
Estimated Enrollment :
750 Patients enrolled
Trial Details
Trial ID
NCT03432624
Start Date
March 1 2018
End Date
January 1 2019
Last Update
February 14 2018
Active Locations (1)
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1
Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University
Shanghai, Shanghai Municipality, China, 200032