Are circulating hematopoietic stem and progenitor cells a potential biomarker for therapy response and disease progression in patients with squamous cell carcinoma of the head and neck? - CHASE-study

Antoni van Leeuwenhoek Ziekenhuis0 个研究点目标入组 30 人开始时间: 待定最近更新: 2024年8月12日

试验速览

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•In order to be eligible to participate in this study, a subject must meet all of the following criteria:;* Have a primary mucosal HNSCC (T1-4, N0-3, M0) of any head and neck anatomic subsite. Patients with recurrent HNSCC are eligible only if they have been disease-free *5 years before enrolment.
•* Be eligible for curative treatment with surgery, radiotherapy, immunotherapy or a combination of these modalities.
•* Screening laboratory values must meet the following criteria: WBC * 2.0x109/L, Neutrophils * 1.5x109/L, Platelets * 100 x109/L, Hemoglobin * 5.5mmol/L, Creatinine * 1.5x ULN, AST * 3 x ULN, ALT * 3 x ULN, Total Bilirubin *1.5 X ULN (except subjects with Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dL).

•* HNSCC patients treated with concomitant chemoradiation therapy.
•* The presence of any malignancy other than the present HNSCC, unless:
•o It has been curatively treated *5 years prior to first study-related blood collection;
•o It is a curatively treated cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, carcinoma in situ of the breast or carcinoma in situ of the bladder.
•* The presence of active, known or suspected autoimmune disease. Subjects are permitted to enroll if they have:
•o Vitiligo;
•o Type I diabetes mellitus;
•o Residual hypothyroidism due to an autoimmune condition, only requiring hormone replacement;
•o Psoriasis not requiring systemic treatment;
•o Conditions not expected to recur in the absence of an external trigger.
•* The presence of a condition requiring systemic treatment with either corticosteroids (>10mg daily prednisone equivalents) or other immunosuppressive medications.
•* The presence of active hepatitis B, hepatitis C, active tuberculosis, syphilis, HIV or AIDS.
•* The presence of any disease or use of medication which, in the investigators* opinion, might significantly influence hematopoiesis.

发起方

Antoni van Leeuwenhoek Ziekenhuis