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临床试验/NL-OMON51942
NL-OMON51942招募中不适用

Follow-up after treatment for testicular cancer: the prospective, single centre FUTURE-testis implementation study - FUTURE-testis

Erasmus MC, Universitair Medisch Centrum Rotterdam0 个研究点目标入组 145 人开始时间: 待定最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
145

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 至 99(—)

入选标准

  • Age >= 18 years.
  • Histologically confirmed testicular cancer without distant metastasis and
  • treated with curative intent less than 6 months ago:
  • o Non-seminomatous germ cell tumours, stage I low risk:
  • * No lymphadenopathy or metastases on the postoperative scan.
  • * Three consecutive blood drawings with normal tumour markers.
  • * Patients undergoing lymph node dissection as a second curative operation
  • after an orchiectomy, can
  • also be included in case that the postoperative scan shows no
  • residual disease or metastases.
  • o Non-seminomatous germ cell tumours, stage I high risk, and combined tumors:
  • * After completion of one cycle of Bleomycin, etoposide and platinum
  • * Biochemical remission at completion of chemotherapy, meaning three
  • consecutive blood drawings with
  • normal tumour markers.
  • * No lymphadenopathy or metastases on the CT scan after completion of
  • chemotherapy.
  • o Seminomatous or non-seminomatous germ cell tumours (after chemotherapy)
  • with complete remission.
  • * Biochemical remission at completion of chemotherapy, meaning three
  • consecutive blood drawings with
  • normal tumour markers.
  • * No lymphadenopathy or metastases on the CT scan after completion of
  • chemotherapy.
  • Scheduled or currently undergoing postoperative surveillance according to
  • national and European guidelines.
  • Signed informed consent.

排除标准

  • Patients with aberrant levels of LDH preoperatively (LDH >248 U/L). •
  • Patients with a severely complicated postoperative course, needing in hospital
  • follow-up longer than 6 months postoperatively • Patients enrolled in other
  • studies that require strict adherence to any specific follow-up practice with
  • regular imaging - yearly or more frequent - of the abdomen and/or thorax •
  • Patients with comorbidity or other malignancy that requires imaging of the
  • abdomen and/or thorax every year or more frequent • Inability to complete the
  • questionnaires due to illiteracy and/or insufficient proficiency of the Dutch

研究者

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