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Surveillance of Association of Immune Status and Prognosis of CNS Germ Cell Tumor Survivors

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ClinicalTrials.gov Identifier: NCT04909307
Recruitment Status : Recruiting
First Posted : June 1, 2021
Last Update Posted : June 3, 2021
Sponsor:
Information provided by (Responsible Party):
Chengcheng Guo, Sun Yat-sen University

Brief Summary:
Platinum-based chemotherapy, alternating at 21-days intervals with cycles of ifosfamide, cisplatin, and etoposide (ICE) and subsequently received radiotherapy were considered as standard treatment for intracranial germ cell tumors. However, whether reliable clinical data can quantify the damage degree of immunologic function caused by chemotherapy and radiotherapy is still unknown. This project regards the level of lymphocyte and immunocyte in peripheral blood as a quantitative index to reflect the dynamic change of the immunologic function of patients with CNS germ cell tumors before and after chemoradiotherapy treatment. Meanwhile, the investigators will also investigate the relationship between the level of lymphocyte and immunocyte in peripheral blood and the response rate of therapy.This study is designed to prospectively analyze the dynamic changes of immune status, prognosis and society function after standard treatment in patients with intracranial germ cell tumor.

Condition or disease
Intracranial Germ Cell Tumor Intracranial Germ Cell CNS Tumor, Childhood Surgery

Detailed Description:

Immune status influences the reaction of anti-tumor and health condition of intracranial germ cell tumor patients. Peripheral blood and cerebrospinal fluid lymphocytes subsets, cytokines reflects those and be measured. Therefore, we designed the study to estimate patients health condition and survival outcomes in order to provides diversified assessment methods.

Peripheral blood will be collected from patients who will undergo surgery and/or neoadjuvant or adjuvant chemoradiotherapy. The setting time is before chemoradiotherapy, finishing chemoradiotherapy, pre-operation, postoperative day 1, day 3, day 5, and day 7. These blood samples will be used for detection and analysis in lymphocyte and immunocyte by flow cytometry.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 36 Months
Official Title: Surveillance of Peripheral Blood Lymphocyte Subsets , Immune Function and Associations With Prognosis and Readiness of Return-to-work of CNS Germ Cell Tumor Survivors
Actual Study Start Date : June 1, 2019
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2023



Primary Outcome Measures :
  1. Association between level of immune function and overall survival in patients with intracranial germ cell tumors. [ Time Frame: 6 months ]
    Patients with intracranial germ cell tumors will be followed, prospectively from the time of discharge using review of the electronic medical record and as local guidance permits, phone calls at 3 and 6 months. The investigators will determine the associations between level of immune function after anti-tumor treatment and the objective remission rate and survival outcomes.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with intracranial germ cell tumors and received anti-tumor therapy, including chemotherapy and radiotherapy.
Criteria

Inclusion Criteria:

  • Primary diagnosis of an intracranial germ cell tumor (Histologically confirmed intracranial non-germinomatous or germinoma germ cell tumor).
  • Histologically unconfirmed pineal and/or suprasellar tumors with serum/CSF beta HCG levels greater than 50 mIU/mL or AFP levels greater than 10 ng/ml or above institutional norm.
  • No history of anti-tumor treatment
  • Female subjects of childbearing potential have a negative pregnancy test and must agree to take effective contraceptive measures during the study period and within 3 months after the last dose;
  • Be willing and able to provide written informed consent/assent for the trial

Exclusion Criteria:

  • Patients with immune function deficiency : immunosuppression status, including autoimmune disease, post-operation of organ transplantation, in-taking immunosuppressive drug, human immunodeficiency virus (HIV) positive patients,
  • Known history of active tuberculosis not adequately treated or positive QuantiFERON TB Gold test.
  • Hypoproteinemia (eg, in case of severe liver disease or nephrotic syndrome) with serum albumin <3.0 g/dL.

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): NCT04909307


Contacts
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Contact: Chengcheng Guo, MD,PhD 020-87343891 guochch@sysucc.org.cn
Contact: Hairong Wang +8618862155823 wanghr@sysucc.org.cn

Locations
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China, Guangdong
Sun Yat-sen University Cancer Center Recruiting
Guangzhou, Guangdong, China
Contact: Chengcheng Guo       guochch@sysucc.org.cn   
Sponsors and Collaborators
Chengcheng Guo
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Responsible Party: Chengcheng Guo, PhD, MD, Principal Investigator, Clinical Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT04909307    
Other Study ID Numbers: ChengchengGuo
First Posted: June 1, 2021    Key Record Dates
Last Update Posted: June 3, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Additional relevant MeSH terms:
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Neoplasms
Neoplasms, Germ Cell and Embryonal
Central Nervous System Neoplasms
Neoplasms by Histologic Type
Nervous System Neoplasms
Neoplasms by Site
Nervous System Diseases