Testicular Germ Cell TumorSENATORNCT03448822
Sentinel Lymph Node Procedure in Testicular Germ Cell Tumour
An observational study of Testicular Germ Cell Tumor, run by The Netherlands Cancer Institute.
Trial summary
Assessment of accuracy of sentinel node biopsy, defined as the false negative rate. 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?
- sentinel node procedure
- Type of treatment
- Surgery or procedure
- How many people
- 76 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2018to 1 Apr 2026
- Phase
- Observational
- 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
Study population: Patients suspected of testicular germ cell tumour
Who may be able to join
- Patients suspected of testicular germ cell tumour, based on physical examination, ultrasound imaging, and tumour markers
- Patients 18 years and older
- No evidence of metastases on first staging (thoraco-abdominopelvic CT)
- Written and signed informed consent
Who cannot join
- Patients with evidence of metastases at first staging
- Patients with a second primary tumour
- Patients with recent (< 6 months before diagnosis) surgical treatment to the external genitals or recent surgical intervention in the inguinal or retroperitoneal regions
- Patients with previous abdominal surgery, necessitating open surgical approach for the sentinel node biopsy
Trial locations and contacts
No sites are listed yet.
About this study
Assessment of accuracy of sentinel node biopsy, defined as the false negative rate.
Read the detailed description
Current practice in patients with Clinical Stage I (CS I) testicular germ cell tumour is active surveillance after orchiectomy, with relapses occurring in 15-20% of patients. The majority of relapses occur in the lymph nodes as lymphogenic spread is the dominant route of dissemination. A sentinel node procedure, in which the sentinel lymph node is resected and pathologically examined, could be more reliable to identify patients who are likely to relapse.
Early identification of patients with micro-metastases in the sentinel node makes it possible to treat these patients at the earliest possible moment. Absence of metastases could lead in the future to a less intensive follow up protocol than the present one.
- Conditions
- Testicular Germ Cell Tumor
- Being tested
- sentinel node procedure
- Medical subject headings
- Testicular Germ Cell Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sentinel node procedureProcedure or surgery
a robot-assisted laparoscopic sentinel node procedure to detect occult lymph node metastasis
| Study group | Role | What they receive |
|---|---|---|
| sentinel node procedure | a robot-assisted laparoscopic sentinel node procedure. Receives: Procedure: sentinel node procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
identify patients witha low risk of cancer recurrenceincluded in current active surveillance protocols.
identify patients who have such a low risk of cancer recurrence that it is not necessary anymore to be included in current active surveillance protocols by removing the sentinal lymph node to check for occult metastasis
Measured: surgery 1 day, follow up 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2018
- Study start1 Sep 2018 (estimated)
- Primary completion1 Apr 2020 (estimated)
- Study completion1 Apr 2026 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Netherlands Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simon Horenblas, MD, PhD, Principal investigator, The Netherlands Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03448822
- Sponsor's protocol ID
- M18TGC
- Acronym
- SENATOR
- Status last verified
- Jan 2018
- First submitted
- 30 Jan 2018
- Last updated
- 22 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sentinel Lymph Node Procedure in Testicular Germ Cell Tumour
- ClinicalTrials.gov ID
- NCT03448822
- Acronym / sponsor ID
- SENATOR / M18TGC
- Conditions
- Testicular Germ Cell Tumor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- The Netherlands Cancer InstituteUniversity, hospital or other
- Study start
- 1 Sep 2018 (estimated)
- Primary completion
- 1 Apr 2020 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 28 Feb 2018 (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.
Assessment of accuracy of sentinel node biopsy, defined as the false negative rate.
Detailed description
Current practice in patients with Clinical Stage I (CS I) testicular germ cell tumour is active surveillance after orchiectomy, with relapses occurring in 15-20% of patients. The majority of relapses occur in the lymph nodes as lymphogenic spread is the dominant route of dissemination. A sentinel node procedure, in which the sentinel lymph node is resected and pathologically examined, could be more reliable to identify patients who are likely to relapse.
Early identification of patients with micro-metastases in the sentinel node makes it possible to treat these patients at the earliest possible moment. Absence of metastases could lead in the future to a less intensive follow up protocol than the present one.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sentinel node procedure | – | Procedure: sentinel node procedurea robot-assisted laparoscopic sentinel node procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suspected of testicular germ cell tumour
Key inclusion criteria (4 listed)
- Patients suspected of testicular germ cell tumour, based on physical examination, ultrasound imaging, and tumour markers
- Patients 18 years and older
- No evidence of metastases on first staging (thoraco-abdominopelvic CT)
- Written and signed informed consent
Key exclusion criteria (4 listed)
- Patients with evidence of metastases at first staging
- Patients with a second primary tumour
- Patients with recent (< 6 months before diagnosis) surgical treatment to the external genitals or recent surgical intervention in the inguinal or retroperitoneal regions
- Patients with previous abdominal surgery, necessitating open surgical approach for the sentinel node biopsy
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 |
|---|---|---|
| sentinel node procedurea robot-assisted laparoscopic sentinel node procedure to detect occult lymph node metastasis | Procedure or surgery | sentinel node procedure |
Primary outcome
identify patients witha low risk of cancer recurrenceincluded in current active surveillance protocols.
Time frame: surgery 1 day, follow up 5 years
identify patients who have such a low risk of cancer recurrence that it is not necessary anymore to be included in current active surveillance protocols by removing the sentinal lymph node to check for occult metastasis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2018.
Related trials for Testicular Germ Cell Tumor
RecruitingObservational study
MAGESTIC Trial: MiRNA in Detecting Active Germ Cell Tumors in Early Suspected and MetastaTIC Disease Trial
Malignant Testicular Germ Cell Tumor
RecruitingPhase 2
Paclitaxel-Bleomycin/Etoposide/Cisplatin vs Bleomycin/Etoposide/Cisplatin in Poor-prognosis Non-seminomatous Germ Cell Tumors (NSGCT) and Unfavorable Tumor Marker Decline
Germ Cell Cancer Metastatic
RecruitingObservational study
International PPB/DICER1 Registry
Pleuropulmonary Blastoma, Sertoli-Leydig Cell Tumor
Active, not recruitingPhase 1
Determining the Biodistribution of an Imaging Tracer (68Ga-FAPi-46) in Patients With Solid Tumors or Hematologic Cancers
Anal Carcinoma, Bladder Carcinoma
Not yet recruiting
Personalized Cancer Support (Thrive Track) to Manage the Emotional Needs of Young Adults With Thyroid, Melanoma and Testicular Cancer, PerCS-YA Trial
Differentiated Thyroid Gland Carcinoma, Malignant Testicular Neoplasm
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.
Simon Horenblas, MD, PhD principal investigator
The Netherlands Cancer Institute
Questions about this trial
What is this clinical trial studying?
An observational study of Testicular Germ Cell Tumor, run by The Netherlands Cancer Institute.
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 4 inclusion and 4 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 22 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Joost Blok, MD (0031 20 5129111, j.blok@nki.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
identify patients witha low risk of cancer recurrenceincluded in current active surveillance protocols. (time frame: surgery 1 day, follow up 5 years). 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 22 Aug 2018.