Detection of MicroRNA-25 in the Diagnosis of Pancreatic Cancer

NCT ID: NCT03432624

Last Updated: 2018-02-14

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 750 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-03-01
• Study Completion Date: 2019-01-01

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.

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 management of PDAC, but only approximately 15% to 20% of patients are candidates for pancreatectomy at the time of diagnosis. For these patients, however, the mortality and morbidity rates after surgery can improve significantly. 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 are a type of non-encoding single-stranded small RNAs with a length of ~22nt. They can regulate the expression of their target mRNAs by inhibiting their translation into proteins. MicroRNAs participate in all physiological and pathological activities, and their abnormal expression profiles are proven to be closely related to the occurrence and development of diseases, including cancer. Recent studies have further proved that not only tissue/cell-line based microRNAs, but circulating microRNAs can be stably detected, and their expression profiles can function as novel markers to be used in the diagnosis and prognosis of diseases.

Pancreatic cancer specific microRNA profiles have also been reported, amongst which microRNA-25 is found to be significantly upregulated in pancreatic cancer patients. There are also studies try to improve the efficacy of pancreatic cancer diagnosis by combining detection of microRNA and CA19-9. Further are there studies proving microRNA-25 as a highly potential 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, with Cohort One in the diagnosis of pancreatic cancer at early stages, to validate the efficacy of microRNA-25 detection in the differentiation of pancreatic cancer and other related diseases, to investigate the relation between microRNA-25 level and pancreatic staging. Patients in Group One will receive a microRNA-25 level detection at the time of diagnosis, along with conventional tumor marker detection and imaging tests, and then be confirmed by pathological study. And, to investigate the efficacy of microRNA-25 level detection in the curative efficacy evaluation and relapse monitoring, patients of Group Two (selected from Group One) will receive a microRNA-25 level detection within one month after surgery and before starting adjuvant therapy, followed by a microRNA-25 level detection every three months along with normal follow-up tests, until relapse is observed with imaging tests.

Conditions

Carcinoma, Pancreatic Ductal

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Experiment Subgroup, Group One

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

Serum MicroRNA-25 detection

Intervention Type: 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 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.

Serum MicroRNA-25 detection

Intervention Type: 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.

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.

Serum MicroRNA-25 detection

Intervention Type: 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.

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.

Serum MicroRNA-25 detection

Intervention Type: 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 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.

Serum MicroRNA-25 detection

Intervention Type: 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.

Interventions

Serum MicroRNA-25 detection

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

Group One:

1. Patient aged 18 years old and above at the time of signing the ICF.

2. 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.

3. 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:

1. Patient aged 18 years old and above at the time of signing the ICF, and with an expected survival time of over 12 months.

2. Prior to the first blood sample withdraw after surgery, patient not treated with radiotherapy or adjuvant therapy.

3. 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:

1. Patient in the period of acute infection.

2. Patient treated with therapies or drugs prior to blood withdraw.

3. Blood sample shows jaundice (TBIL≥17.1μmol/L) and hematolysis (to be decided by the serum sample preparer).

4. Blood sample has been stored for one year and above.

Group Two:

1. Patient treated with therapies or drugs prior to first blood withdraw after surgery.

2. Patient shows symptoms of remote metases.

3. Blood sample shows jaundice (TBIL≥17.1μmol/L) and hematolysis (to be decided by the serum sample preparer).

4. Blood sample has been stored for one year and above.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Xian-Jun Yu

Director, Head of Otolaryngology, Principal Investigator, Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Shanghai, Shanghai Municipality, China

Countries

China

Central Contacts

Xianjun Yu, doctor

Role: CONTACT

yuxianjun@fudanpci.org

+86-21-6417-5590

Other Identifiers

CSPAC-030

Identifier Type: -

Identifier Source: org_study_id