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

29. mai 2021 oppdatert av: Chengcheng Guo

Surveillance of Peripheral Blood Lymphocyte Subsets , Immune Function and Associations With Prognosis and Readiness of Return-to-work of CNS Germ Cell Tumor Survivors

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.

Studieoversikt

Status

Rekruttering

Forhold

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Forventet)

150

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Navn: Chengcheng Guo, MD,PhD
Telefonnummer: 020-87343891
E-post: guochch@sysucc.org.cn

Studer Kontakt Backup

Navn: Hairong Wang
Telefonnummer: +8618862155823
E-post: wanghr@sysucc.org.cn

Studiesteder

Kina
- Guangdong
  - Guangzhou, Guangdong, Kina
    - Rekruttering
    - Sun Yat-Sen University Cancer Center
    - Ta kontakt med:
      
      Chengcheng Guo
      
      E-post: guochch@sysucc.org.cn

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

Barn
Voksen
Eldre voksen

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Patients with intracranial germ cell tumors and received anti-tumor therapy, including chemotherapy and radiotherapy.

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Association between level of immune function and overall survival in patients with intracranial germ cell tumors. Tidsramme: 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.	6 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Chengcheng Guo

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. juni 2019

Primær fullføring (Forventet)

31. desember 2022

Studiet fullført (Forventet)

31. desember 2023

Datoer for studieregistrering

Først innsendt

26. mai 2021

Først innsendt som oppfylte QC-kriteriene