Cervical CancerSENTIXNCT02494063
Sentinel Lymph Node Biopsy in Patients With Early Stages Cervical Cancer
An observational study of Cervical Cancer, run by Charles University, Czech Republic at 1 site in Czechia.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Sentinel lymph node biopsy and At least unilateral systematic pelvic lymph node dissection
- Type of treatment
- Surgery or procedure
- How many people
- 600 participants
- Where
- 1 siteCzechia
- Study dates
- Jun 2016to Feb 2024
- How long will I take part?
- 7 Years
- 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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with early stages cervical cancer
Who may be able to join
- 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)
Show all 25Show fewer
- 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
Who cannot join
- Neoadjuvant chemotherapy
- Pregnancy
- History of pelvic or abdominal radiotherapy
- HIV positivity / AIDS
- Adenosquamous cancer or adenocarcinoma unusual type (non HPV related - such as: mucinous, clear cell, mesonephric)
- Control Group:
- Pregnancy
- History of pelvic or abdominal radiotherapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Observational Trial on Sentinel Lymph Node Biopsy in Patients With Early Stage Cervical Cancer
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.
Read the detailed description
Patients will be enrolled in the study at the time of surgery planning; at this point, a patient´s consent will be requested if inclusion criteria are fulfilled (histological type, FIGO stage, age, performance status, lymph node clinical status). The following procedures will be provided prior to surgery: clinical staging (MRI or EUS), medical data collection, adverse events assessment, lymphedema assessment, quality of life questionnaire, ECOG performance status, weight and height, standard pre-operative laboratory workup, pregnancy test if clinically indicated.
Surgery should be done within 6 weeks of the imaging study (MRI or expert US). During the surgery, local or distant cancer spread outside of the cervix will be excluded, SLN will be detected, and all SLN will be sent for intra-operative pathologic evaluation. In patients with SLN detection on both sides of the pelvis no other lymph nodes will be removed and they will continue in the study. SLN biopsy will be followed by radical hysterectomy (type B, C1, or C2) or fertility-sparing procedure, according to the pre-operative plan.
Intra-operatively, three groups of patient will be excluded from the SLN study group (though they can be included in the control group):
- Patients with intra-operative detection of more advanced disease stage (> IB1)
- Patients with failure to detect SLN bilaterally (either no SLN detected or only on one side of the pelvis)
- Patients with intra-operative pathologic detection of macrometastases or micrometastases in SLN
In these patients who were excluded from the study group, further surgery and adjuvant treatment will be provided according to the institutional guidelines. These patients will remain in a database and reasons for their exclusion from the SLN study group will be entered into the SIS (Form 2).
A control group will be established to compare postoperative morbidity in patients after SLN biopsy only and after complete pelvic lymphadenectomy. Patients in whom complete lymphadenectomy was performed at least on one side of the pelvis will be eligible for the control group.
In patients, who continue in the study, all SLNs will be processed by pathologists according to the protocol for SLN ultrastaging (Chapter 7.4.2; Appendix 11). If macrometastases or micrometastases or isolated tumor cells are detected in any of the SLNs by pathologic ultrastaging after the surgery, adjuvant radiotherapy will be recommended to the patient. No adjuvant treatment will be offered to those with negative final lymph node status, confirmed pre-operative disease FIGO stage (IA1 - IB1), and adequately performed radical hysterectomy with negative parametrial and vaginal margins.
Follow-up will consist of visits at regular intervals of 6 months after the surgery (additional visits in shorter intervals can be scheduled according to institutional guidelines). The following procedures will be provided at each visit during the follow-up period: pelvic examination, symptomatic lymphocele assessment, quality of life assessment (6 and 12 months after the surgery), adverse events assessment, and secondary lower extremity lymphedema assessment (maximum 6 years after surgery in SLN group, 4 years in Control group). Other imaging studies will be done only if clinically indicated. Any postoperative complication or disease recurrence will be managed according to the institutional guidelines.
Outcomes after fertility sparing procedures in selected centres with be collected (i.e. morbidity after cervical procedure or ovarian transposition, treatment of infertility, pregnancy rates and complications).
- Conditions
- Cervical Cancer
- Being tested
- Sentinel lymph node biopsy, At least unilateral systematic pelvic lymph node dissection
- Keywords
- cervical cancer, sentinel lymph node, lymphadenectomy
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sentinel lymph node biopsyProcedure or surgery
Bilateral sentinel lymph node biopsy, pathologic ultrastaging
At least unilateral systematic pelvic lymph node dissectionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Sentinel lymph node (SLN) | Only sentinel lymph node biopsy, no further pelvic lymph nodes removal, radical hysterectomy. Receives: Procedure: Sentinel lymph node biopsy | |
| Control | Control group is composed by either those who were enrolled into the trial, but who did not fulfil intra-operative criteria (especially failure to detect SLN on both pelvic side walls) or those in whom systematic lymphadenectomy is planned upfront. Receives: Procedure: At least unilateral systematic pelvic lymph node dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence rate at the 24th month of follow-up (cervical recurrences after fertility-sparing procedures will be excluded)
Recurrence rate (RR) will be estimated at the 24th month of follow-up to prove a non-inferiority of SLN biopsy to the reference value (RR 24th month: 7 %).
Measured: 24 months
Secondary outcomes (11)
Prevalence of symptomatic pelvic lymphocele
Reduction in the prevalence of at least 30% to the reference prevalence (6%).
Measured: 2 years
Prevalence of lower extremity lymphedema
Reduction in the prevalence of at least 30% to the reference prevalence (30%).
Measured: 2 years
Postoperative morbidity
Early postoperative morbidity (30 days after surgery) will be evaluated using 5-grade "Dindo" Classification of surgical complications. Late postoperative morbidity (from 30 days up to 2 years after surgery) will be evaluated using Common Terminology Criteria for Adverse Events v4.0 (CTCAE)
Measured: 2 years
DFS (Disease-free survival)
Disease-free survival after treatment with primary surgery until first recurrence.
Measured: 2 years
Pelvic DFS (Pelvic Disease-free survival)
Disease-free survival after treatment with primary surgery until first recurrence within the pelvis.
Measured: 2 years
Quality of life (QoL)
The quality of life (QoL) will be assessed by European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 self-administered multi-dimensional scale cancer specific questionnaire, which is validated in 81 languages. It consists of 5 function scales, three symptom scales, six single-items and a global QoL score.
Measured: 1 year
Intra-operative morbidity
Intra-operative morbidity will be evaluated using 5-grade "Dindo" Classification of surgical complications.
Measured: 1 month
FNR (False Negative Rate) of intra-operative pathologic SLN evaluation
Proportion of patients with lymph nodes negative on intraoperative evaluation but positive on final ultrastaging
Measured: 2 years
DFS in SLN negative patients
Disease free survival in patients with SLN negative on final ultrastaging
Measured: 2 years
Recurrence rate safety margins
Recurrence rate safety margin (> 0.12) as the study stopping rule will be examined when the first 30, 60,150 and 300 patients complete the 12-month follow-up.
Measured: 2 years
Overall survival
Overall survival
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2015 (estimated)
- Study startJun 2016
- Primary completionDec 2022
- Study completionFeb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Charles University, Czech RepublicThe sponsor's other registered studies.
- 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
- 600 participants (actual)
- Target duration
- 7 Years
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Cibula, Charles University, Czech Republic
- Investigators
- David Cibula, MD, Principal investigator, Gynecologic Oncology Center, Department of Obstetrics and Gynecology, General University Hospital and 1st Faculty of Medicine, Charles University Prague, Czechia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02494063
- Sponsor's protocol ID
- CEEGOG CX-01
- Other IDs
- ENGOT-Cx 2, CEEGOG CX-01, Protocol v2.0 (1st amendment), Protocol v3.0 (2nd amendment), Protocol v3.1 (3rd amendment), 16-31643A, 19-03-00023
- Acronym
- SENTIX
- Status last verified
- Feb 2024
- First submitted
- 6 Jul 2015
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zikan M, Fischerova D, Pinkavova I, Slama J, Weinberger V, Dusek L, Cibula D. A prospective study examining the incidence of asymptomatic and symptomatic lymphoceles following lymphadenectomy in patients with gynecological cancer. Gynecol Oncol. 2015 May;137(2):291-8. doi: 10.1016/j.ygyno.2015.02.016. Epub 2015 Feb 24.
PubMed 25720294Cibula D, Oonk MH, Abu-Rustum NR. Sentinel lymph node biopsy in the management of gynecologic cancer. Curr Opin Obstet Gynecol. 2015 Feb;27(1):66-72. doi: 10.1097/GCO.0000000000000133.
PubMed 25502426Giammarile F, Bozkurt MF, Cibula D, Pahisa J, Oyen WJ, Paredes P, Olmos RV, Sicart SV. The EANM clinical and technical guidelines for lymphoscintigraphy and sentinel node localization in gynaecological cancers. Eur J Nucl Med Mol Imaging. 2014 Jul;41(7):1463-77. doi: 10.1007/s00259-014-2732-8. Epub 2014 Mar 8.
PubMed 24609929Cibula D, Abu-Rustum NR, Dusek L, Slama J, Zikan M, Zaal A, Sevcik L, Kenter G, Querleu D, Jach R, Bats AS, Dyduch G, Graf P, Klat J, Meijer CJ, Mery E, Verheijen R, Zweemer RP. Bilateral ultrastaging of sentinel lymph node in cervical cancer: Lowering the false-negative rate and improving the detection of micrometastasis. Gynecol Oncol. 2012 Dec;127(3):462-6. doi: 10.1016/j.ygyno.2012.08.035. Epub 2012 Aug 31.
PubMed 22943880Cibula D, Abu-Rustum NR, Dusek L, Zikan M, Zaal A, Sevcik L, Kenter GG, Querleu D, Jach R, Bats AS, Dyduch G, Graf P, Klat J, Lacheta J, Meijer CJ, Mery E, Verheijen R, Zweemer RP. Prognostic significance of low volume sentinel lymph node disease in early-stage cervical cancer. Gynecol Oncol. 2012 Mar;124(3):496-501. doi: 10.1016/j.ygyno.2011.11.037. Epub 2011 Nov 25.
PubMed 22120175Cibula D, Abu-Rustum NR, Benedetti-Panici P, Kohler C, Raspagliesi F, Querleu D, Morrow CP. New classification system of radical hysterectomy: emphasis on a three-dimensional anatomic template for parametrial resection. Gynecol Oncol. 2011 Aug;122(2):264-8. doi: 10.1016/j.ygyno.2011.04.029. Epub 2011 May 17.
PubMed 21592548Cibula D, Abu-Rustum NR. Pelvic lymphadenectomy in cervical cancer--surgical anatomy and proposal for a new classification system. Gynecol Oncol. 2010 Jan;116(1):33-7. doi: 10.1016/j.ygyno.2009.09.003. Epub 2009 Oct 17.
PubMed 19837449Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
PubMed 15273542Cibula D, Marnitz S, Jarkovsky J, Kocian R, Dundr P, Klat J, Zapardiel I, Arencibia O, Landoni F, Presl J, Raspagliesi F, Zikan M, van Lonkhuijzen LR, Torne A, Slama J, Minar L, Ostojich M, Pilka R, Petiz AF, Petzel A, Burgetova A, Fischerova D, Nemejcova K, Kohler C. Sentinel lymph node biopsy without systematic pelvic lymphadenectomy in females with early-stage cervical cancer: final outcome of the SENTIX prospective, single-arm, noninferiority, international trial. Nat Cancer. 2025 Sep;6(9):1585-1594. doi: 10.1038/s43018-025-01016-y. Epub 2025 Jul 4.
PubMed 40615729Borcinova M, Kohler C, Nemejcova K, Zapardiel I, Klat J, Fruhauf F, Kalist V, Szatkowski W, Wydra D, Kocian R, Laky R, Toth R, Misiek M, Redecha M, Martin I, Kridelka F, Burgetova A, Santiago Garcia FJ, Van Gorp T, Szewczyk G, Kipp B, Poka R, Coronado PJ, Cadron I, Luyckx M, Fischerova D, Fischbach R, Cibula D. Preoperative tumour size assessment in patients with early-stage cervical cancer: Final results of the SENTIX study. Gynecol Oncol. 2025 May;196:160-167. doi: 10.1016/j.ygyno.2025.04.005. Epub 2025 Apr 11.
PubMed 40220456Cibula D, Kohler C, Jarkovsky J, Kocian R, Dundr P, Klat J, Zapardiel I, Landoni F, Fruhauf F, Fischbach R, Borcinova M, Fischerova D. Magnetic resonance imaging and ultrasound examination in preoperative pelvic staging of early-stage cervical cancer: post-hoc analysis of SENTIX study. Ultrasound Obstet Gynecol. 2025 Apr;65(4):495-502. doi: 10.1002/uog.29205. Epub 2025 Mar 25.
PubMed 40130299Kocian R, Kohler C, Bajsova S, Jarkovsky J, Zapardiel I, Di Martino G, van Lonkhuijzen L, Sehnal B, Sanchez OA, Gil-Ibanez B, Martinelli F, Presl J, Minar L, Pilka R, Kascak P, Havelka P, Michal M, van Gorp T, Nemejcova K, Dundr P, Cibula D. Sentinel lymph node pathological ultrastaging: Final outcome of the Sentix prospective international study in patients with early-stage cervical cancer. Gynecol Oncol. 2024 Sep;188:83-89. doi: 10.1016/j.ygyno.2024.06.015. Epub 2024 Jun 27.
PubMed 38941963Borcinova M, Ragosch V, Jarkovsky J, Bajsova S, Pilka R, Glickman A, Garrido-Mallach S, Raspagliesi F, Szatkowski W, Pakiz M, Snyman LC, Kocian R, Tamussino K, Kalist V, Michal M, Segovia MG, Poka R, Kipp B, Szewczyk G, Wydra D, Toth R, Vinnytska A, Fischerova D, Siegler K, Cibula D. Challenges in lower limb lymphoedema assessment based on limb volume change: Lessons learnt from the SENTIX prospective multicentre study. Gynecol Oncol. 2022 Jan;164(1):76-84. doi: 10.1016/j.ygyno.2021.10.089. Epub 2021 Nov 8.
PubMed 34763939Cibula D, Kocian R, Plaikner A, Jarkovsky J, Klat J, Zapardiel I, Pilka R, Torne A, Sehnal B, Ostojich M, Petiz A, Sanchez OA, Presl J, Buda A, Raspagliesi F, Kascak P, van Lonkhuijzen L, Barahona M, Minar L, Blecharz P, Pakiz M, Wydra D, Snyman LC, Zalewski K, Zorrero C, Havelka P, Redecha M, Vinnytska A, Vergote I, Tingulstad S, Michal M, Kipp B, Slama J, Marnitz S, Bajsova S, Hernandez A, Fischerova D, Nemejcova K, Kohler C. Sentinel lymph node mapping and intraoperative assessment in a prospective, international, multicentre, observational trial of patients with cervical cancer: The SENTIX trial. Eur J Cancer. 2020 Sep;137:69-80. doi: 10.1016/j.ejca.2020.06.034. Epub 2020 Aug 1.
PubMed 32750501Cibula D, Dusek J, Jarkovsky J, Dundr P, Querleu D, van der Zee A, Kucukmetin A, Kocian R. A prospective multicenter trial on sentinel lymph node biopsy in patients with early-stage cervical cancer (SENTIX). Int J Gynecol Cancer. 2019 Jan;29(1):212-215. doi: 10.1136/ijgc-2018-000010.
PubMed 30640706
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Trial on Sentinel Lymph Node Biopsy in Patients With Early Stage Cervical Cancer
- ClinicalTrials.gov ID
- NCT02494063
- Acronym / sponsor ID
- SENTIX / CEEGOG CX-01
- Conditions
- Cervical Cancer
- Keywords
- cervical cancer, sentinel lymph node, lymphadenectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Dec 2022 (actual)
- Study completion
- Feb 2024 (actual)
- First posted
- 10 Jul 2015 (estimated)
- 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.
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.
Detailed description
Patients will be enrolled in the study at the time of surgery planning; at this point, a patient´s consent will be requested if inclusion criteria are fulfilled (histological type, FIGO stage, age, performance status, lymph node clinical status). The following procedures will be provided prior to surgery: clinical staging (MRI or EUS), medical data collection, adverse events assessment, lymphedema assessment, quality of life questionnaire, ECOG performance status, weight and height, standard pre-operative laboratory workup, pregnancy test if clinically indicated.
Surgery should be done within 6 weeks of the imaging study (MRI or expert US). During the surgery, local or distant cancer spread outside of the cervix will be excluded, SLN will be detected, and all SLN will be sent for intra-operative pathologic evaluation. In patients with SLN detection on both sides of the pelvis no other lymph nodes will be removed and they will continue in the study. SLN biopsy will be followed by radical hysterectomy (type B, C1, or C2) or fertility-sparing procedure, according to the pre-operative plan.
Intra-operatively, three groups of patient will be excluded from the SLN study group (though they can be included in the control group):
- Patients with intra-operative detection of more advanced disease stage (> IB1)
- Patients with failure to detect SLN bilaterally (either no SLN detected or only on one side of the pelvis)
- Patients with intra-operative pathologic detection of macrometastases or micrometastases in SLN
In these patients who were excluded from the study group, further surgery and adjuvant treatment will be provided according to the institutional guidelines. These patients will remain in a database and reasons for their exclusion from the SLN study group will be entered into the SIS (Form 2).
A control group will be established to compare postoperative morbidity in patients after SLN biopsy only and after complete pelvic lymphadenectomy. Patients in whom complete lymphadenectomy was performed at least on one side of the pelvis will be eligible for the control group.
In patients, who continue in the study, all SLNs will be processed by pathologists according to the protocol for SLN ultrastaging (Chapter 7.4.2; Appendix 11). If macrometastases or micrometastases or isolated tumor cells are detected in any of the SLNs by pathologic ultrastaging after the surgery, adjuvant radiotherapy will be recommended to the patient. No adjuvant treatment will be offered to those with negative final lymph node status, confirmed pre-operative disease FIGO stage (IA1 - IB1), and adequately performed radical hysterectomy with negative parametrial and vaginal margins.
Follow-up will consist of visits at regular intervals of 6 months after the surgery (additional visits in shorter intervals can be scheduled according to institutional guidelines). The following procedures will be provided at each visit during the follow-up period: pelvic examination, symptomatic lymphocele assessment, quality of life assessment (6 and 12 months after the surgery), adverse events assessment, and secondary lower extremity lymphedema assessment (maximum 6 years after surgery in SLN group, 4 years in Control group). Other imaging studies will be done only if clinically indicated. Any postoperative complication or disease recurrence will be managed according to the institutional guidelines.
Outcomes after fertility sparing procedures in selected centres with be collected (i.e. morbidity after cervical procedure or ovarian transposition, treatment of infertility, pregnancy rates and complications).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sentinel lymph node (SLN) | – | Procedure: Sentinel lymph node biopsyOnly sentinel lymph node biopsy, no further pelvic lymph nodes removal, radical hysterectomy. |
| Control | – | Procedure: At least unilateral systematic pelvic lymph node dissectionControl group is composed by either those who were enrolled into the trial, but who did not fulfil intra-operative criteria (especially failure to detect SLN on both pelvic side walls) or those in whom systematic lymphadenectomy is planned upfront. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with early stages cervical cancer
Key inclusion criteria (25 listed)
- 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
Key exclusion criteria (8 listed)
- Neoadjuvant chemotherapy
- Pregnancy
- History of pelvic or abdominal radiotherapy
- HIV positivity / AIDS
- Adenosquamous cancer or adenocarcinoma unusual type (non HPV related - such as: mucinous, clear cell, mesonephric)
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 lymph node biopsyBilateral sentinel lymph node biopsy, pathologic ultrastaging | Procedure or surgery | Sentinel lymph node (SLN) |
| At least unilateral systematic pelvic lymph node dissection | Procedure or surgery | Control |
Primary outcome
Recurrence rate at the 24th month of follow-up (cervical recurrences after fertility-sparing procedures will be excluded)
Time frame: 24 months
Recurrence rate (RR) will be estimated at the 24th month of follow-up to prove a non-inferiority of SLN biopsy to the reference value (RR 24th month: 7 %).
11 secondary outcomes
Prevalence of symptomatic pelvic lymphocele
Time frame: 2 years
Prevalence of lower extremity lymphedema
Time frame: 2 years
Postoperative morbidity
Time frame: 2 years
DFS (Disease-free survival)
Time frame: 2 years
Pelvic DFS (Pelvic Disease-free survival)
Time frame: 2 years
Quality of life (QoL)
Time frame: 1 year
Intra-operative morbidity
Time frame: 1 month
FNR (False Negative Rate) of intra-operative pathologic SLN evaluation
Time frame: 2 years
DFS in SLN negative patients
Time frame: 2 years
Recurrence rate safety margins
Time frame: 2 years
Overall survival
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
- Background: PubMed 25720294Zikan M, Fischerova D, Pinkavova I, Slama J, Weinberger V, Dusek L, Cibula D. A prospective study examining the incidence of asymptomatic and symptomatic lymphoceles following lymphadenectomy in patients with gynecological cancer. Gynecol Oncol. 2015 May;137(2):291-8. doi: 10.1016/j.ygyno.2015.02.016. Epub 2015 Feb 24.
- Background: PubMed 25502426Cibula D, Oonk MH, Abu-Rustum NR. Sentinel lymph node biopsy in the management of gynecologic cancer. Curr Opin Obstet Gynecol. 2015 Feb;27(1):66-72. doi: 10.1097/GCO.0000000000000133.
- Background: PubMed 24609929Giammarile F, Bozkurt MF, Cibula D, Pahisa J, Oyen WJ, Paredes P, Olmos RV, Sicart SV. The EANM clinical and technical guidelines for lymphoscintigraphy and sentinel node localization in gynaecological cancers. Eur J Nucl Med Mol Imaging. 2014 Jul;41(7):1463-77. doi: 10.1007/s00259-014-2732-8. Epub 2014 Mar 8.
- Background: PubMed 22943880Cibula D, Abu-Rustum NR, Dusek L, Slama J, Zikan M, Zaal A, Sevcik L, Kenter G, Querleu D, Jach R, Bats AS, Dyduch G, Graf P, Klat J, Meijer CJ, Mery E, Verheijen R, Zweemer RP. Bilateral ultrastaging of sentinel lymph node in cervical cancer: Lowering the false-negative rate and improving the detection of micrometastasis. Gynecol Oncol. 2012 Dec;127(3):462-6. doi: 10.1016/j.ygyno.2012.08.035. Epub 2012 Aug 31.
- Background: PubMed 22120175Cibula D, Abu-Rustum NR, Dusek L, Zikan M, Zaal A, Sevcik L, Kenter GG, Querleu D, Jach R, Bats AS, Dyduch G, Graf P, Klat J, Lacheta J, Meijer CJ, Mery E, Verheijen R, Zweemer RP. Prognostic significance of low volume sentinel lymph node disease in early-stage cervical cancer. Gynecol Oncol. 2012 Mar;124(3):496-501. doi: 10.1016/j.ygyno.2011.11.037. Epub 2011 Nov 25.
- Background: PubMed 21592548Cibula D, Abu-Rustum NR, Benedetti-Panici P, Kohler C, Raspagliesi F, Querleu D, Morrow CP. New classification system of radical hysterectomy: emphasis on a three-dimensional anatomic template for parametrial resection. Gynecol Oncol. 2011 Aug;122(2):264-8. doi: 10.1016/j.ygyno.2011.04.029. Epub 2011 May 17.
- Background: PubMed 19837449Cibula D, Abu-Rustum NR. Pelvic lymphadenectomy in cervical cancer--surgical anatomy and proposal for a new classification system. Gynecol Oncol. 2010 Jan;116(1):33-7. doi: 10.1016/j.ygyno.2009.09.003. Epub 2009 Oct 17.
- Background: PubMed 15273542Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
- Derived from this study: PubMed 40615729Cibula D, Marnitz S, Jarkovsky J, Kocian R, Dundr P, Klat J, Zapardiel I, Arencibia O, Landoni F, Presl J, Raspagliesi F, Zikan M, van Lonkhuijzen LR, Torne A, Slama J, Minar L, Ostojich M, Pilka R, Petiz AF, Petzel A, Burgetova A, Fischerova D, Nemejcova K, Kohler C. Sentinel lymph node biopsy without systematic pelvic lymphadenectomy in females with early-stage cervical cancer: final outcome of the SENTIX prospective, single-arm, noninferiority, international trial. Nat Cancer. 2025 Sep;6(9):1585-1594. doi: 10.1038/s43018-025-01016-y. Epub 2025 Jul 4.
- Derived from this study: PubMed 40220456Borcinova M, Kohler C, Nemejcova K, Zapardiel I, Klat J, Fruhauf F, Kalist V, Szatkowski W, Wydra D, Kocian R, Laky R, Toth R, Misiek M, Redecha M, Martin I, Kridelka F, Burgetova A, Santiago Garcia FJ, Van Gorp T, Szewczyk G, Kipp B, Poka R, Coronado PJ, Cadron I, Luyckx M, Fischerova D, Fischbach R, Cibula D. Preoperative tumour size assessment in patients with early-stage cervical cancer: Final results of the SENTIX study. Gynecol Oncol. 2025 May;196:160-167. doi: 10.1016/j.ygyno.2025.04.005. Epub 2025 Apr 11.
- Derived from this study: PubMed 40130299Cibula D, Kohler C, Jarkovsky J, Kocian R, Dundr P, Klat J, Zapardiel I, Landoni F, Fruhauf F, Fischbach R, Borcinova M, Fischerova D. Magnetic resonance imaging and ultrasound examination in preoperative pelvic staging of early-stage cervical cancer: post-hoc analysis of SENTIX study. Ultrasound Obstet Gynecol. 2025 Apr;65(4):495-502. doi: 10.1002/uog.29205. Epub 2025 Mar 25.
- Derived from this study: PubMed 38941963Kocian R, Kohler C, Bajsova S, Jarkovsky J, Zapardiel I, Di Martino G, van Lonkhuijzen L, Sehnal B, Sanchez OA, Gil-Ibanez B, Martinelli F, Presl J, Minar L, Pilka R, Kascak P, Havelka P, Michal M, van Gorp T, Nemejcova K, Dundr P, Cibula D. Sentinel lymph node pathological ultrastaging: Final outcome of the Sentix prospective international study in patients with early-stage cervical cancer. Gynecol Oncol. 2024 Sep;188:83-89. doi: 10.1016/j.ygyno.2024.06.015. Epub 2024 Jun 27.
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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.
David Cibula, MD principal investigator
Gynecologic Oncology Center, Department of Obstetrics and Gynecology, General University Hospital and 1st Faculty of Medicine, Charles University Prague, Czechia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Cancer, run by Charles University, Czech Republic at 1 site in Czechia.
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 25 inclusion and 8 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: finished, as of the sponsor's last update on 8 Feb 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 Czechia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence rate at the 24th month of follow-up (cervical recurrences after fertility-sparing procedures will be excluded) (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02494063, which also lists 15 linked publications.
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 8 Feb 2024.