DRKS00019187尚未招募不适用
PTM-TK: Non interventional study on the implementation of quantitative determination of DRH1 antibody (AB) equivalents in serum by using the DRH1 antibody clone with PT Monitor® as part of therapy control in patients with HPV16-induced vulva- and cervical tumors - PTM-TK
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- Female
入选标准
- •1. >18 years
- •2. Willingness and ability to submit declaration of consent after receiving relevant information, and signed declaration of consent
- •3. Consent to compliance with the required follow-up appointments
- •4. Diagnosis of HPV16-induced vulva carcinoma or pre-cancer requiring treatment
- •5. Diagnosis of an HPV16-induced cervical carcinoma or pre-cancer requiring treatment
- •6. Positive Prevo Check® result at day of hospital admittance and positive PT Monitor® result at start of therapy t0 (= 7 days before to 7 days after initial therapeutic intervention to remove tumor)
- •7. Therapy of HPV16-positive tumor not started before t0.
排除标准
- •1. An operative or medical condition that would expose the patient to increased risk from the study. The investigator will make the decision based on the patient's history and/or clinical picture or lab values.
- •2. Lack of willingness and ability to provide declaration of consent
- •3. Patients who have been vaccinated against HPV. Patients who have been vaccinated against HPV show a positive concentration of antibodies against HPV16 L1 (equals DRH1 antibody equivalents) due to the immunisation by the vaccination
- •4. Patients who are vaccinated against HPV during the study period
- •5. Patients with diagnosed HPV16 tumor whose therapy has already started before the start of this study.
- •6. Participation in a concurrent study with the exception of observational studies
- •7. HIV-positive patients
研究者
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