Carcinoma, Pancreatic DuctalNCT03432624
Detection of MicroRNA-25 in the Diagnosis of Pancreatic Cancer
An observational study of Carcinoma, Pancreatic Ductal, run by Fudan University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Carcinoma, Pancreatic Ductal
- What is being tested?
- Serum MicroRNA-25 detection
- How many people
- 750 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2018to 1 Jan 2019
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients diagnosed and treated at the Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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:
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University
Shanghai, Shanghai Municipality, 200032
About this study
Official title: A Clinical Validation Study on the Efficacy of MicroRNA-25 Level Detection in Assisting the Diagnosis of Pancreatic Cancer
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.
Read the 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
- Being tested
- Serum MicroRNA-25 detection
- Medical subject headings
- Carcinoma, Pancreatic Ductal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum MicroRNA-25 detectionDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Experiment Subgroup, Group One | Experiment Subgroup, Group One consists of pancreatic cancer patients, in which 120 are operable, and 120 are not operable. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Diagnostic Test: Serum MicroRNA-25 detection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
- Sensitivity: Se=P(T+|D+)=a/(a+c)
- Specificity: Sp=P(T-|D-)=d/(b+d)
- Total Coincidence Rate: TC= (a+d)/N
- Youden Index: YI=Se+Sp-1
Measured: throughout the trial, average one year
Secondary outcomes (1)
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).
Measured: throughout the trial, average one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2018
- Study start1 Mar 2018 (estimated)
- Primary completion1 Oct 2018 (estimated)
- Study completion1 Jan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Pancreatic DuctalStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 750 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xian-Jun Yu, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03432624
- Sponsor's protocol ID
- CSPAC-030
- Status last verified
- Feb 2018
- First submitted
- 24 Jan 2018
- Last updated
- 14 Feb 2018
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Validation Study on the Efficacy of MicroRNA-25 Level Detection in Assisting the Diagnosis of Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT03432624
- Acronym / sponsor ID
- CSPAC-030
- Conditions
- Carcinoma, Pancreatic Ductal
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Mar 2018 (estimated)
- Primary completion
- 1 Oct 2018 (estimated)
- Study completion
- 1 Jan 2019 (estimated)
- First posted
- 14 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Experiment Subgroup, Group One | – | Diagnostic Test: Serum MicroRNA-25 detectionExperiment Subgroup, Group One consists of pancreatic cancer patients, in which 120 are operable, and 120 are not operable. |
| Control Subgroup, Group One | – | Diagnostic Test: Serum MicroRNA-25 detectionControl 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. |
| Interference Subgroup, Group One | – | Diagnostic Test: Serum MicroRNA-25 detectionInterference 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. |
| Experiment Subgroup, Group Two | – | Diagnostic Test: Serum MicroRNA-25 detectionGroup 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. |
| Control Subgroup, Group Two | – | Diagnostic Test: Serum MicroRNA-25 detectionControl 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed and treated at the Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
- Patient treated with therapies or drugs prior to first blood withdraw after surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serum MicroRNA-25 detectionThe 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. | Diagnostic test | Control Subgroup, Group One, Control Subgroup, Group Two, Experiment Subgroup, Group One, Experiment Subgroup, Group Two, Interference Subgroup, Group One |
Primary outcome
Fourfold Table Analysis Indexes
Time frame: throughout the trial, average one year
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
1 secondary outcome
Statistical Analysis Indexes
Time frame: throughout the trial, average one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoma, Pancreatic Ductal, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xianjun Yu, doctor (+86-21-6417-5590, yuxianjun@fudanpci.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fourfold Table Analysis Indexes (time frame: throughout the trial, average one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2018.