NCT02494063Completed
Sentinel Lymph Node Biopsy in Patients With Early Stages Cervical Cancer
A Prospective Observational Trial on Sentinel Lymph Node Biopsy in Patients With Early Stage Cervical Cancer
Source: ClinicalTrials.gov · Last updated 8 Feb 2024
Brief summary (registry, in English)
To evaluate whether a less radical surgical approach with sentinel lymph node biopsy is non-inferior to treatment with systematic pelvic lymphadenectomy. The null hypothesis is that the recurrence rate after SLN biopsy is non-inferior to the reference recurrence rate of 7 % (at the 24th month of follow-up) in patients after systematic pelvic lymphadenectomy, but that the less radical surgery is associated with significantly lower postoperative morbidity.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 600 (actual)
- First submitted
- 6 Jul 2015
- Start date
- Jun 2016
- Primary completion date
- Dec 2022
- Lead sponsor
- Charles University, Czech Republic
- Diseases
- Cervical cancer
- NCT number
- NCT02494063
What you commit to
- Study type: Observational
- Participants enrolled: 600
- From Jun 2016 to the primary completion date, Dec 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Neoadjuvant chemotherapy
Other illness
- History of pelvic or abdominal radiotherapy
- HIV positivity / AIDS
- Adenosquamous cancer or adenocarcinoma unusual type (non HPV related - such as: mucinous, clear cell, mesonephric)
- History of pelvic or abdominal radiotherapy
Other
- Pregnancy
- Control Group:
- Pregnancy
Who the study is looking for
- Preoperative:
- FIGO stage IA1+LVSI; IA2; IB1
- No evidence of bulky or suspicious pelvic lymph nodes or distant metastases in preoperative conventional imaging studies
- Performance status ECOG: 0 - 1
- Age ≥ 18 years, ≤ 75 years
- Squamous cell carcinoma OR Adenocarcinoma usual type (HPV related)
- Suitable candidates for primary surgical treatment such as:
- radical hysterectomy in tumors ≤ 4 cm in the largest diameter OR
- fertility-sparing treatment in tumors ≤ 2 cm in the largest diameter
- History of second primary cancer only if \> 5 years with no evidence of disease
- Approved and signed Informed consent
- Intra-operative
- Bilateral SLN detection
- Negative intra-operative pathologic SLN evaluation (frozen section)
- No intra-operative evidence of more advanced disease (\>IB1)
- Preoperative:
- FIGO stage IA1 + LVSI; IA2; IB
- Performance status ECOG: 0-1
- Age ≥ 18 years, ≤ 75 years
- Patient is not pregnant
- No history of pelvic or abdominal radiotherapy
- Patient scheduled for surgical treatment including systematic pelvic lymphadenectomy
- Approved and signed Informed Consent
- Intra-operative:
- Systematic pelvic lymphadenectomy performed at least on one side of the pelvis
Criteria the registry did not label
- SLN study group:
Age in the registry: 18 years to 75 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Gynecologic Oncology Center in Prague Coordinator of this site? Confirm its status | Prague | Czechia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.