Testicular Germ Cell TumorPITERLANDNCT06133699
Sentinel Lymph Node Biopsy in Stage AI-IIA Germ Cell Tumors
A study testing Orchofuniculectomy with simultaneous laparoscopic biopsy of the sentinel lymph node using indocyanine green dye with/without methylene blue dye. and Radiopharmaceutical administration (Technetium/methylene blue) in people with Testicular Germ Cell Tumor, run by N.N. Petrov National Medical Research Center of Oncology at 1 site in Russia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Testicular Germ Cell Tumor
- What is being tested?
- Orchofuniculectomy with simultaneous laparoscopic biopsy of the sentinel lymph node using indocyanine green dye with/without methylene blue dye. and Radiopharmaceutical administration (Technetium/methylene blue)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteRussia
- Study dates
- 8 Nov 2023to 30 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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)
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Federal State Budgetary Institute N.N. Petrov National Medical Research Center of Oncology Ministry of Health of the Russian Federation
Saint Petersburg, 197758
Eldar Mamizhev, PhD (Med.), Oncologist, +79217696923, mamijev@mail.ru
About this study
Official title: 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).
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.
Read more
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.
Read the detailed description
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).
Orchofuniculectomy Study participants will undergo orchofuniculectomy through an inguinal or laparoscopic approach.
After completion of the orchofuniculectomy, indocyanine green (ICG) dye with or without methylene blue dye will be injected into the spermatic cord stump.
Second stage of treatment Laparoscopic access and port placement
Under general anesthesia, with the patient in the supine position with arms extended along the body and legs spread apart, after processing the surgical field, laparoscopic ports will be installed under sterile conditions as follows:
- In the pubic region, 1 cm below the navel, an optical trocar is installed according to the Hasson technique (pneumoperitoneum (P=14 mmHg).
- Installation of trocars in the right iliac region, in the left iliac region and above the pubic symphysis (5, 5 and 11 mm, respectively).
The patient is then placed in the Trendelenburg position. BSLU Next, in the operating room, the surgeon will use a gamma detector to determine the location of the sentinel lymph nodes, followed by removal of one or more (up to 4) lymph nodes from which the signal is received. These lymph nodes will be sent for histological examination.
The results of the work performed will present indicators of relapse-free survival after SLNB, as well as functional outcomes, such as postoperative complications, duration of hospital treatment, frequency of retrograde ejaculation in patients with stage IA-IIA testicular germ cell tumor. The data obtained will allow optimizing the selection of patients for surgical treatment, as well as identifying prognostic factors for the adjuvant stage of therapy.
Additionally, as part of the work, it is planned to study the expression profile of microRNAs in blood plasma, with subsequent assessment as a potential prognostic and predictive factor in patients with germ cell tumors. For this purpose, blood will be drawn from patients before surgery and 10 days after surgery.
- Conditions
- Testicular Germ Cell Tumor
- Being tested
- Orchofuniculectomy with simultaneous laparoscopic biopsy of the sentinel lymph node using indocyanine green dye with/without methylene blue dye., Radiopharmaceutical administration (Technetium/methylene blue)
- Keywords
- testicular, Germ cell tumor, ICG, SLNB
- Medical subject headings
- Testicular Germ Cell Tumor, Neoplasms, Germ Cell and Embryonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orchofuniculectomy with simultaneous laparoscopic biopsy of the sentinel lymph node using indocyanine green dye with/without methylene blue dye.Procedure or surgery
Study participants will undergo orchofuniculectomy through an inguinal or laparoscopic approach. After completion of the orchofuniculectomy, indocyanine green (ICG) dye with or without methylene blue dye will be injected into the spermatic cord stump. Next step is detection with a gamma detector the sentinel lymph nodes and follow removing of one or more (up to 4) lymph nodes during laparoscopy. These lymph nodes will be sent for histological examination.
Radiopharmaceutical administration (Technetium/methylene blue)Diagnostic test
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).
| Study group | Role | What they receive |
|---|---|---|
| SLNB | Experimental | Not described Receives: Procedure: Orchofuniculectomy with simultaneous laparoscopic biopsy of the sentinel lymph node using indocyanine green dye with/without methylene blue dye.; Diagnostic Test: Radiopharmaceutical administration (Technetium/methylene blue) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse-free survival during the first two years after SLNB
Measured: two years
The percentage of patients who did not require adjuvant treatment after primary endoscopic SLNB
Measured: two years
Evaluation of miRNAs as a potential prognostic and prognostic factor in patients with testicular germ cell tumors.
Measured: two years
• Assess the correlation between computed tomography and positive lymph nodes on examination.
Measured: two years
Secondary outcomes (2)
Сomplication rate
Measured: two years
All-cause mortality
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2023
- Study start8 Nov 2023
- Primary completion30 Nov 2024 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Testicular Germ Cell TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- N.N. Petrov National Medical Research Center of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06133699
- Sponsor's protocol ID
- 01112023-PITERLAND
- Acronym
- PITERLAND
- Status last verified
- Nov 2023
- First submitted
- 10 Nov 2023
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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).
- ClinicalTrials.gov ID
- NCT06133699
- Acronym / sponsor ID
- PITERLAND / 01112023-PITERLAND
- Conditions
- Testicular Germ Cell Tumor
- Keywords
- testicular, Germ cell tumor, ICG, SLNB
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- N.N. Petrov National Medical Research Center of OncologyUniversity, hospital or other
- Study start
- 8 Nov 2023 (actual)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 15 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Orchofuniculectomy Study participants will undergo orchofuniculectomy through an inguinal or laparoscopic approach.
After completion of the orchofuniculectomy, indocyanine green (ICG) dye with or without methylene blue dye will be injected into the spermatic cord stump.
Second stage of treatment Laparoscopic access and port placement
Under general anesthesia, with the patient in the supine position with arms extended along the body and legs spread apart, after processing the surgical field, laparoscopic ports will be installed under sterile conditions as follows:
- In the pubic region, 1 cm below the navel, an optical trocar is installed according to the Hasson technique (pneumoperitoneum (P=14 mmHg).
- Installation of trocars in the right iliac region, in the left iliac region and above the pubic symphysis (5, 5 and 11 mm, respectively).
The patient is then placed in the Trendelenburg position. BSLU Next, in the operating room, the surgeon will use a gamma detector to determine the location of the sentinel lymph nodes, followed by removal of one or more (up to 4) lymph nodes from which the signal is received. These lymph nodes will be sent for histological examination.
The results of the work performed will present indicators of relapse-free survival after SLNB, as well as functional outcomes, such as postoperative complications, duration of hospital treatment, frequency of retrograde ejaculation in patients with stage IA-IIA testicular germ cell tumor. The data obtained will allow optimizing the selection of patients for surgical treatment, as well as identifying prognostic factors for the adjuvant stage of therapy.
Additionally, as part of the work, it is planned to study the expression profile of microRNAs in blood plasma, with subsequent assessment as a potential prognostic and predictive factor in patients with germ cell tumors. For this purpose, blood will be drawn from patients before surgery and 10 days after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SLNB | Experimental | Procedure: Orchofuniculectomy with simultaneous laparoscopic biopsy of the sentinel lymph node using indocyanine green dye with/without methylene blue dye., Diagnostic Test: Radiopharmaceutical administration (Technetium/methylene blue) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Orchofuniculectomy with simultaneous laparoscopic biopsy of the sentinel lymph node using indocyanine green dye with/without methylene blue dye.Study participants will undergo orchofuniculectomy through an inguinal or laparoscopic approach. After completion of the orchofuniculectomy, indocyanine green (ICG) dye with or without methylene blue dye will be injected into the spermatic cord stump. Next step is detection with a gamma detector the sentinel lymph nodes and follow removing of one or more (up to 4) lymph nodes during laparoscopy. These lymph nodes will be sent for histological examination. | Procedure or surgery | SLNB |
| 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). | Diagnostic test | SLNB |
Primary outcome
Relapse-free survival during the first two years after SLNB
Time frame: two years
The percentage of patients who did not require adjuvant treatment after primary endoscopic SLNB
Time frame: two years
Evaluation of miRNAs as a potential prognostic and prognostic factor in patients with testicular germ cell tumors.
Time frame: two years
• Assess the correlation between computed tomography and positive lymph nodes on examination.
Time frame: two years
2 secondary outcomes
Сomplication rate
Time frame: two years
All-cause mortality
Time frame: two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Federal State Budgetary Institute N.N. Petrov National Medical Research Center of Oncology Ministry of Health of the Russian Federation
Saint Petersburg, Russia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Orchofuniculectomy with simultaneous laparoscopic biopsy of the sentinel lymph node using indocyanine green dye with/without methylene blue dye. and Radiopharmaceutical administration (Technetium/methylene blue) in people with Testicular Germ Cell Tumor, run by N.N. Petrov National Medical Research Center of Oncology at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse-free survival during the first two years after SLNB (time frame: two years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2024.