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Dynamic Changes of Sera Immunoglobulin G4 and Interleukin-10 in the Patients of Pancreatic Cancer After Chemotherapy

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ClinicalTrials.gov Identifier: NCT02654288
Recruitment Status : Unknown
Verified December 2015 by Peking Union Medical College Hospital.
Recruitment status was:  Recruiting
First Posted : January 13, 2016
Last Update Posted : January 26, 2016
Sponsor:
Collaborator:
National Natural Science Foundation of China
Information provided by (Responsible Party):
Peking Union Medical College Hospital

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Pancreatic Neoplasms Inflammation Other: gemcitabine-based chemotherapy

Detailed Description:
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.

Study Design
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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Dynamic Changes of the Serum Level of Immunoglobulin G4(IgG4) and Interleukin-10(IL-10) in the Patients of Pancreatic Cancer After Gemcitabine-based Chemotherapy
Study Start Date : January 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : January 2019

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Groups and Cohorts
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Group/Cohort Intervention/treatment
single arm
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


Outcome Measures
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Primary Outcome Measures :
  1. The dynamic change patterns of sera IgG4 and IL-10 of pancreatic cancer after gemcitabine-based chemotherapy will be recorded. [ Time Frame: one year ]
    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.


Secondary Outcome Measures :
  1. The correlation of the changes of IgG4 and IL-10 with the tumor marker during chemotherapy will be analyzed [ Time Frame: one year ]
    The sera IgG4 and IL-10 and tumor marker will be detected during chemotherapy and the correlations will be analyzed.

  2. 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 [ Time Frame: one year ]
    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.

  3. The correlation of the changes of IgG4 and IL-10 with the overall survival after chemotherapy will be analyzed. [ Time Frame: Two year ]
    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.


Biospecimen Retention:   Samples Without DNA
The IgG4 in serum from peripheral blood will be detected.(4ml/test)

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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.
Criteria

Inclusion Criteria:

  1. Age ranging from 18 to 75-year old;
  2. Pathological verified pancreatic cancer including adenocarcinoma and cancerogenesis of intraductal papillary mucinous neoplasm (IPMN);
  3. Pancreatic cancer patients receiving adjuvant chemotherapy after curative resection; pancreatic cancer patients with recurrent lesions receiving chemotherapy after curative resection; pancreatic cancer patients with unresectable tumor receiving chemotherapy;
  4. Patients have good physical status to receive chemotherapy;
  5. No history of chemotherapy and the current regimen contains gemcitabine;
  6. No medical history of IgG4 related diseases and other connective tissue diseases;
  7. Written consent is available.

Exclusion Criteria:

  1. Patient younger than 18-year old;
  2. Patient has chemotherapy before;
  3. The physical status is too poor to receive chemotherapy;
  4. The patient has history of IgG4 related diseases and some other connective diseases;
  5. Written consent is not available.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02654288


Contacts
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Contact: Qiaofei Liu, MD 86-15201693370 qfliu@aliyun.com

Locations
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China, Beijing
Department of General Surgery, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Sciences Recruiting
Beijing, Beijing, China, 100730
Contact: Qiaofei Liu, MD    86-15201693370      
Sponsors and Collaborators
Peking Union Medical College Hospital
National Natural Science Foundation of China
Investigators
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Principal Investigator: Quan Liao, MD Department of General Surgery, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Sciences
More Information
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Publications:

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Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT02654288     History of Changes
Other Study ID Numbers: 81272573
First Posted: January 13, 2016    Key Record Dates
Last Update Posted: January 26, 2016
Last Verified: December 2015
Keywords provided by Peking Union Medical College Hospital:
pancreatic cancer
gemcitabine
chemotherapy
immunoglobulin G 4
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Pancreatic Diseases
Inflammation
Pathologic Processes
Digestive System Diseases
Endocrine System Diseases
Gemcitabine
Immunoglobulins
 Antibodies
Immunoglobulin G
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs