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?
- Conditions
- Squamous cell carcinoma of the head and neckhead and neck cancer10038666
- Registration Number
- NL-OMON46829
- Lead Sponsor
- Antoni van Leeuwenhoek Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 30
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.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method