An observational study in Pancreatic Neoplasms and Inflammation, sponsored by Peking Union Medical College Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-01-26.
Sponsored by Peking Union Medical College Hospital · Observational
Investigators have previously found that the infiltration of immunoglobulin G4(IgG4) positive plasma cells in tumor tissue predicts a poor prognosis of pancreatic cancer after curative resection. Investigators further attempt to explore the possible roles of IgG4 and the inducer of IgG4, interleukin-10(IL-10), in the chemotherapy of pancreatic cancer. In this primary study, investigators plan to observe the dynamic changes of sera IgG4 and IL-10 in peripheral blood after gemcitabine-based chemotherapy and analyze the correlations of IgG4 and IL-10 with the response of gemcitabine and overall survival of pancreatic cancer.
Human immunoglobulin G(IgG) is a family consisting of four members, IgG1, IgG2, IgG3 and IgG4.IgG4 is regarded as an inhibitory IgG which can inhibit the activation of immune responses[1]. Recently it was reported that IgG4 could weaken the activation of macrophages to promote cancer progression[2]. Autoimmune pancreatitis(AIP) is the most common clinical manifestation of IgG4-related sclerosing diseases(IRSD) which is characterized by abundant infiltration of IgG4 positive plasma cells[3].Although there are abundant infiltrations of IgG4 positive plasma cells in pancreatic lesion of AIP, the correlation of IgG4 positive plasma cells with pancreatic cancer has never been reported.Investigators have previously found that higher level of infiltration of IgG4 positive plasma cells in tumor tissue predicts a poor prognosis of pancreatic cancer after curative resection(not published).Investigators further attempt to explore the possible roles of IgG4 and the inducer of IgG4, IL-10, in the chemotherapy of pancreatic cancer.Since gemcitabine is the first line chemotherapeutic drug for pancreatic cancer, in this primary study,investigators plan to observe the dynamic changes of sera IgG4 and IL-10 in peripheral blood after gemcitabine-based chemotherapy and analyze the correlations of IgG4 and IL-10 with the response of gemcitabine and overall survival of pancreatic cancer.
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This study's planned enrollment of 300 is above the median of 200 across 620 observational studies indexed under Pancreatic Neoplasms.
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Pancreatic cancer patients without history of chemotherapy will be recruited. After evulation of the physical status, the patients will receive gemcitabine-based chemotherapy.The peripheral blood will be collected and the sera IgG4 and IL-10 will be detected during chemotherapy. Then the correlation of the dynamic changes of IgG4 and IL-10 with the response of chemotherapy and the overall survival will be analyzed.
Exclusion Criteria:
The pancreatic cancer patients without history of chemotherapy who will receive gemcitabine-based chemotherapy will be recruited and the sera IgG4 and IL-10 will be detected before and after chemotherapy.
Other: gemcitabine-based chemotherapy
The dynamic change patterns of sera IgG4 and IL-10 of pancreatic cancer after gemcitabine-based chemotherapy will be recorded.
Investigators attempt to analyze the dynamic change patterns of sera IgG4 and IL-10 of pancreatic cancer after gemcitabine-based chemotherapy and theoretically investigators imagine that the sera IgG4 and IL-10 will be elevated in most of the patients.
Time frame: one year
The correlation of the changes of IgG4 and IL-10 with the tumor marker during chemotherapy will be analyzed
The sera IgG4 and IL-10 and tumor marker will be detected during chemotherapy and the correlations will be analyzed.
Time frame: one year
The correlation of the changes of IgG4 and IL-10 with the efficacy of chemotherapy evaluated by intravenous enhanced CT during chemotherapy will be analyzed
The sera IgG4 and IL-10 will be detected during chemotherapy and the chemotherapeutic efficacy will be evaluated by intravenous enhanced CT scan and the correlation will be analyzed.
Time frame: one year
The correlation of the changes of IgG4 and IL-10 with the overall survival after chemotherapy will be analyzed.
The sera IgG4 and IL-10 will be detected during chemotherapy and the overall survival will be recorded and then the correlation will be analyzed.
Time frame: Two year
This study is status unknown, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.
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Peking Union Medical College Hospital