Assessment of accuracy of sentinel node biopsy, defined as the false negative rate.
ID
Source
Brief title
Condition
- Reproductive neoplasms male malignant and unspecified
- Haematological and lymphoid tissue therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study endpoint will be the false negative rate of sentinel node
biopsy. False negative sentinel node rate will be calculated as follows:
[number of patients with a false-negative sentinel node] / [total number of
patients with tumor positive nodes]
Patients with a false-negative sentinel node are defined as patients of whom
the sentinel nodes were negative on histopathological examination, but who
develop a recurrence during follow-up. Recurrence can be assessed by
CT-scanning, thoracic X-ray, and serum tumour markers.
Secondary outcome
Sensitivity and specificity of the sentinel node approach, recurrence rate,
cancer specific and overall survival, percentage of occult lymph node
metastases, extra operating time, number of adverse events, and morbidity.
Background summary
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 lymh 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 micrometastases 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 objective
Assessment of accuracy of sentinel node biopsy, defined as the false negative
rate.
Study design
This will be a multicenter prospective observational study.
All patients that are included will undergo a sentinel node procedure. The
histology of the sentinel node will divide the patients in two groups: those
who have occult lymph node metastases and those without lymph node metastases.
Node negative patients will be observed by active surveillance.
Treatment of node positive patients will be at the discretion of the institute
and treating medical oncologist. As the clinical significance of a sentinel
node positive for occult metastases is currently unknown, this patient group
will be closely monitored. If the treatment approach is insufficient for the
node positive group, this treatment approach can be amended during the study.
Study burden and risks
Study participation will require patients to undergo a lymphoscintigraphy,
single photo emission computed tomography with computed tomography (SPECT/CT)
and an invasive procedure for the laparoscopic retrieval of the sentinel lymph
node. This retrieval will take place in the same surgical session as the
orchiectomy. Thus, no extra operating session is necessary.
The burden to the participant will be some (four to five) small scars, longer
operating time and associated surgical risks (e.g. bleeding risk).
The immediate benefit for the participant will be knowledge of their sentinel
lymph node status.
The benefit in the future will be earlier diagnosis, a lower rate of
false-negative diagnosis, the possibility to treat metastatic patients (tumour
positive sentinel node) at an earlier stage, and a change in the follow up
(reduction of abdominal CT-scans and subsequently less exposure to radiation).
Plesmanlaan 121
Amsterdam 1066CX
NL
Plesmanlaan 121
Amsterdam 1066CX
NL
Listed location countries
Age
Inclusion criteria
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
Exclusion criteria
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT03448822 |
| CCMO | NL62350.031.18 |