Detection of MicroRNA-25 in the Diagnosis of Pancreatic Cancer

NCT03432624 | Unknown FDA Drug

• 1 other identifier: CSPAC-030
• Study Type: observational
• Target: 750
• Locations: 1 country
• Sites: 1

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 potentially curative resection, the mortality and morbidity rates after surgery can improve significantly, but who accounts for no more than 20% of all pancreatic patients. It is therefore an effective way to improve the treatment efficacy for pancreatic cancer by discovering novel detection methods for pancreatic cancer, especially at early stages. MicroRNAs have been proved in recent years as functional disease markers, and circulating microRNA-25 is reported of high pancreatic cancer specificity and can be used as a novel marker for pancreatic cancer. A detection kit "MicroRNA (microRNA-25) Qualitative Detection Kit (Fluorescent PCR Method)" is produced and proven to be effective in assisting the diagnosis of pancreatic cancer through clinical trials held independently in three state-level hospitals in China. To further validate the efficacy of the kit, the researchers in this study intend to compare the sensibility and specificity of microRNA-25 level detection and other diagnosis methods, including detection of conventional tumor markers (CA19-9, CA125, CA50, CEA) and imaging (CT, MRI, PET/CT), both in separation and combined, in the diagnosis of pancreatic cancer.

Conditions

Carcinoma, Pancreatic Ductal

Outcome Measures

Primary Outcomes (1)

• Fourfold Table Analysis Indexes

  Using the Fourfold Table to analyze the diagnosis value of the tested reagent in comparison with the golden standard (pathological test) from mainly four indexes: Sensitivity, Specificity, Total Coincidence Rate and Youden Index (%). Fourfold Table Tested reagent Golden standard Total Positive (D+) Negative (D-) Positive (T+) a b a+b Negative (T-) c d c+d Total a+c b+d N=a+b+c+d 1. Sensitivity: Se=P(T+\|D+)=a/(a+c) 2. Specificity: Sp=P(T-\|D-)=d/(b+d) 3. Total Coincidence Rate: TC= (a+d)/N 4. Youden Index: YI=Se+Sp-1

  throughout the trial, average one year

Secondary Outcomes (1)

• Statistical Analysis Indexes

  throughout the trial, average one year

Study Arms (5)

Experiment Subgroup, Group One

Experiment Subgroup, Group One consists of pancreatic cancer patients, in which 120 are operable, and 120 are not operable.

Diagnostic Test: Serum MicroRNA-25 detection

Control Subgroup, Group One

Control Subgroup, Group One consists of 150 patients, in which 30 are of gallbladder carcinoma, 60 are of biliary tract lower segment carcinoma, 60 are of gastrointestinal carcinoma.

Diagnostic Test: Serum MicroRNA-25 detection

Interference Subgroup, Group One

Interference Subgroup, Group One consists of 150 patients, in which 60 are of chronic pancreatitis, 90 are of other types of pancreatic tumor, in which 30 are of IPMN (intraductal papillary mucinous neoplasm), 30 are of SPT (solid pseudopapillary tumor of pancreas), and 30 pancreatic cystic adenoma.

Diagnostic Test: Serum MicroRNA-25 detection

Experiment Subgroup, Group Two

Group Two consists of 210 patients selected from Group One, of which the Experiment Subgroup, Group Two consists of the 120 operable pancreatic cancer patients who have had successful surgery.

Diagnostic Test: Serum MicroRNA-25 detection

Control Subgroup, Group Two

Control Subgroup, Group Two consists of 90 patients of other cancers who have had successful surgery, in which 30 are of gallbladder carcinoma, and 60 are of biliary tract lower segment carcinoma.

Diagnostic Test: Serum MicroRNA-25 detection

Interventions

Serum MicroRNA-25 detection DIAGNOSTIC_TEST

The level of microRNA-25 in serum of patients will be detected using the MicroRNA (microRNA-25) Qualitative Detection Kit (Fluorescent PCR Method) and following the manufacture's instruction.\*all arms are given the same intervention.

Control Subgroup, Group One; Control Subgroup, Group Two; Experiment Subgroup, Group One; Experiment Subgroup, Group Two; Interference Subgroup, Group One

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed and treated at the Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Carcinoma, Pancreatic Ductal

Condition Hierarchy (Ancestors)

Carcinoma, Ductal; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Ductal, Lobular, and Medullary; Pancreatic Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Central Study Contacts

Xianjun Yu, doctor

CONTACT

+86-21-6417-5590; yuxianjun@fudanpci.org

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Head of Otolaryngology, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: January 24, 2018
• First Posted: February 14, 2018
• Study Start: March 1, 2018
• Primary Completion: October 1, 2018
• Study Completion: January 1, 2019
• Last Updated: February 14, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)