An observational study in Carcinoma, Pancreatic Ductal, sponsored by Fudan University. Status unknown at 1 site in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-02-14.
Sponsored by Fudan University · Observational
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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.
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.
57 studies on the registry are indexed under Carcinoma, Pancreatic Ductal; 10 are open to participants now.
This study's planned enrollment of 750 is above the median of 216 across 12 observational studies indexed under Carcinoma, Pancreatic Ductal.
Browse Carcinoma, Pancreatic Ductal studies →Fudan University is the lead sponsor of 1,317 studies on the registry; 645 are open to participants now.
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Patients diagnosed and treated at the Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center
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Group One:
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 ), 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:
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:
Group Two:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 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 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
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 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
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.
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
Time frame: throughout the trial, average one year
Statistical Analysis Indexes
Statistical Analysis will evaluate the diagnosing efficacy of the tested reagent with two indexes, Kappa Value and AUC: Kappa Value (K Value) Analysis: to investigate the consistency of the tested reagent with golden standard. The definition of K is: K=(p_0-p_e)/(1-p_e ), Where p0 is the relative observed agreement of the tested reagent and/or the comparison reagents (identical to accuracy), and pe is the hypothetical probability of chance agreement, using the observed data to calculate the probabilities of each observer randomly seeing each category. AUC (%): to investigate the diagnosing efficacy of the tested reagent through calculating the AUC (Area Under the ROC Curve). The ROC curve is created by plotting the true positive rate (TPR) against the false positive rate (FPR) at various threshold setting. The TPR is also known as sensitivity. The FPR is also known as the fall-out or probability of false alarm and can be calculated as (1-specificity).
Time frame: throughout the trial, average one year
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Mar 2018; primary completion for Oct 2018, 7 months later.
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This study is status unknown, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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