A Prospective, Single-center, Clinical Trial to Evaluate the Efficacy of Sentinel Lymph Node Biopsy in Stage AI-IIA Germ Cell Tumors (Seminoma/Nonseminoma)(PITERLAND).
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- The percentage of patients who did not require adjuvant treatment after primary endoscopic SLNB
研究概览
简要总结
The goal of this clinical trial is to evaluate the efficacy of sentinel lymph node biopsy in stage AI-IIA germ cell tumors (seminoma/nonseminoma). The main questions it aims to answer are:
- To evaluate relapse-free survival during the first two years after SLNB.
- To estimate the percentage of patients who did not require adjuvant treatment after primary endoscopic SLNB.
- Determine the microRNA expression profile in blood plasma, evaluate miRNAs as a potential prognostic and predictive factor in patients with testicular germ cell tumors.
- Assess the correlation between computed tomography and positive lymph nodes on examination.
Participants will undergo:
- surgical treatment including orchofuniculectomy with simultaneous laparoscopic biopsy of the sentinel lymph node using indocyanine green dye with/without methylene blue dye.
- 24 hours before the procedure, a radiopharmaceutical (RP) is injected into the spermatic cord, followed by SPECT to determine the regional sentinel lymph node(s).
- The level of microRNA will be examined before surgery and 10 days after surgery.
详细描述
Research Design This study is a prospective, single-center, non-randomized study evaluating the role of primary endoscopic SLNB on progression-free survival in patients with stage I-II germ cell seminoma/non-seminoma tumor without adjuvant treatment. Additionally, the study will determine the prognostic value of miRNAs as a noninvasive marker in clinical practice.
This study plans to recruit 44 male patients with a preliminary diagnosis of testicular tumor.
Patients who meet the inclusion/exclusion criteria will undergo surgical treatment including orchofuniculectomy with a simultaneous assessment and biopsy of the sentinel retroperitoneal lymph node.
The first stage of treatment Pre-operative preparation At the preoperative stage, it is planned to perform 3D modeling of computed tomography slices to visualize tumor conglomerates and vascular topography. A map of lymph node dissection zones will also be compiled. The anatomical boundaries of lymph node dissection are the aorta, the inferior vena cava, the iliac vessels, their bifurcation zones, the renal and mesenteric vessels. Due to the distribution of lymph nodes into cohorts (from 1 to 9 in each case), further histological examination of the surgical material will assess the completeness of the performed lymph node dissection.
Radiopharmaceutical administration (Technetium/methylene blue) 24 hours before surgery, a radiotracer (RP) will be injected into the spermatic cord followed by SPECT to identify the regional sentinel lymph node(s).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male person at least 18 years of age at the time of signing the informed consent form;
- •Provisional diagnosis of testicular tumor with isolated retroperitoneal lymphadenopathy;
- •Computed tomography data of the abdominal cavity and retroperitoneal space with axial visualization of lymphadenopathy (within 6 weeks before the planned date of surgical treatment): at least one lymph node larger than 1 cm.
排除标准
- •Severe or uncontrolled concomitant chronic diseases or acute diseases;
- •Any condition that, in the opinion of the physician, may limit compliance with the study;
- •Poor general condition (ECOG > 2, KPS < 70);
- •Refusal of the patient to comply with the study procedures or refusal of the patient to continue participating in the study;
- •Development of diseases or conditions that prevent the patient's continued participation in the study;
- •AFP level is higher than reference values and / or b-hCG > 100 mIU/ml;
- •Presence of a second malignant disease;
- •History of systemic antitumor therapy and/or radiotherapy;
- •Inadequate bone marrow, liver, kidney function: (Neutrophils < 1.5 x 10^9/l, Platelets < 100 x 10^9/l, ALT > 3 x ULN, AST > 3 x ULN, Total bilirubin > 1.5 xULN, GFR <35 ml/min)
结局指标
主要结局
The percentage of patients who did not require adjuvant treatment after primary endoscopic SLNB
时间窗: two years
Relapse-free survival during the first two years after SLNB
时间窗: two years
Evaluation of miRNAs as a potential prognostic and prognostic factor in patients with testicular germ cell tumors.
时间窗: two years
• Assess the correlation between computed tomography and positive lymph nodes on examination.
时间窗: two years
次要结局
- All-cause mortality(two years)
- Сomplication rate(two years)