Uterine Cervical DysplasiaSENTICOL2NCT01639820
Comparison of Pelvic Lymphadenectomy Versus Isolated Sentinel Lymph Node Biopsy Procedure for Early Stages of Cervical Cancers : a Multicenter Study With Evaluation of Medico-economic Impacts
A study testing identification of sentinel nodes + full pelvic lymph-node dissection and only identification of sentinel nodes (without pelvic lymph-node dissection) in people with Uterine Cervical Dysplasia, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Patients with early cervical cancer are usually treated with radical hysterectomy + pelvic lymph-node dissection. The study randomizes patients in 2 arms. The control arm is the classical surgical treatment including identification of the sentinel nodes, full pelvic lymph-node dissection and radical hysterectomy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Uterine Cervical Dysplasia
- What is being tested?
- identification of sentinel nodes + full pelvic lymph-node dissection and only identification of sentinel nodes (without pelvic lymph-node dissection)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 267 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2009to Dec 2012
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women 18 years of age or older,
- Absence of contraindication to laparoscopy,
- Uterine cervical carcinoma (every histological type except neuroendocrine),
- Stage IA1 with lymphatic tumor space involvement (LVSI) or IA2 diagnosed on cervical conization; or stage IA2, IB1 or IIA detected by clinical examination, confirmed by biopsy and measured by the MRI, the highest diameter being lower to 4 cm (a preoperative brachytherapy is allowed for tumors 2 to 4 cm in diameter),
- Negative pregnancy test for women able to procreate,
- Having the French National Social Security
- Signed informed consent
Who cannot join
- Neuroendocrine carcinoma,
- In situ carcinoma or stage IA1 without LVSI,
- Maximal tumoral diameter measured by MRI more than 4 cm,
- Stage IB1 by "down-staging",
- Stage IB2, IIB to IVB, including those who had a response to neoadjuvant treatment (chemotherapy or RT + chemotherapy) ,
- Presence of distant metastases,
Show all 13Show fewer
- Progression of the cervical cancer or recurrence,
- History of pelvic lymphadenectomy,
- Other cancer diagnosed during the course of treatment,
- Contraindication to the injected products : allergy known to Patent Blue or rhenium sulfide,
- History of severe allergy (history of Quincke's edema, anaphylactic shock),
- Patient who does not understand, speak or write the French language,
- Pregnant woman
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Pelvic Lymphadenectomy Versus Isolated Sentinel Lymph Node Biopsy Procedure for Early Stages of Cervical Cancers : a Randomized Multicenter Study With Evaluation of Medico-economic Impacts
Patients with early cervical cancer are usually treated with radical hysterectomy + pelvic lymph-node dissection. The study randomizes patients in 2 arms. The control arm is the classical surgical treatment including identification of the sentinel nodes, full pelvic lymph-node dissection and radical hysterectomy.
The experimental arm is only sentinel node identification + radical hysterectomy.
- Conditions
- Uterine Cervical Dysplasia
- Being tested
- identification of sentinel nodes + full pelvic lymph-node dissection, only identification of sentinel nodes (without pelvic lymph-node dissection)
- Keywords
- Cervical cancer, early stage carcinoma, FIGO IA1 IA2 IB1 IIA, sentinel lymph node biopsy, pelvic lymphadenectomy, Surgery of uterine cervical carcinoma, medico economic impact, quality of life
- Medical subject headings
- Uterine Cervical Dysplasia, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
identification of sentinel nodes + full pelvic lymph-node dissectionProcedure or surgery
identification of sentinel nodes + full pelvic lymph-node dissection
only identification of sentinel nodes (without pelvic lymph-node dissection)Procedure or surgery
only identification of sentinel nodes (without pelvic lymph-node dissection)
| Study group | Role | What they receive |
|---|---|---|
| Strategy A | Experimental | Only identification of sentinel nodes (without pelvic lymph-node dissection) Receives: Procedure: only identification of sentinel nodes (without pelvic lymph-node dissection) |
| Strategy B | Other | Identification of sentinel nodes + full pelvic lymph-node dissection Receives: Procedure: identification of sentinel nodes + full pelvic lymph-node dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with complications observed in the 2 arms during the per and post-operative period up to 6 months
Measured: 6 months after surgery
Secondary outcomes (7)
Score of the questionnaire of quality of life at 30 days, 3 months and 6 months after surgery
Measured: 30 days, 3 months and 6 months after surgery
the costs of both studied strategies
Measured: At the surgery until 6 months
the detection rate of the sentinel node technique in the 2 arms
Measured: Day 1
the false negative rate in the control arm
Measured: Day 1
the sites of recurrence for each strategy
Measured: Day 1
Number of patients without 3 years-recurrence for each strategy
Measured: 3 years after surgery
Number of patient treated by radio chemotherapy because of the presence of micrometastases in the sentinel node
Measured: 30 days, 3 months and 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2012 (estimated)
- Study startJan 2009
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Uterine Cervical DysplasiaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 267 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01639820
- Sponsor's protocol ID
- 2008.515
- Acronym
- SENTICOL2
- Status last verified
- Dec 2025
- First submitted
- 7 Sep 2010
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Bats AS, Frati A, Mathevet P, Orliaguet I, Querleu D, Zerdoud S, Leblanc E, Gauthier H, Uzan C, Deandreis D, Darai E, Kerrou K, Marret H, Lenain E, Froissart M, Lecuru F. Contribution of lymphoscintigraphy to intraoperative sentinel lymph node detection in early cervical cancer: Analysis of the prospective multicenter SENTICOL cohort. Gynecol Oncol. 2015 May;137(2):264-9. doi: 10.1016/j.ygyno.2015.02.018. Epub 2015 Feb 26.
PubMed 25727652Mathevet P, Lecuru F, Uzan C, Boutitie F, Magaud L, Guyon F, Querleu D, Fourchotte V, Baron M, Bats AS; Senticol 2 group. Sentinel lymph node biopsy and morbidity outcomes in early cervical cancer: Results of a multicentre randomised trial (SENTICOL-2). Eur J Cancer. 2021 May;148:307-315. doi: 10.1016/j.ejca.2021.02.009. Epub 2021 Mar 24.
PubMed 33773275
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Pelvic Lymphadenectomy Versus Isolated Sentinel Lymph Node Biopsy Procedure for Early Stages of Cervical Cancers : a Randomized Multicenter Study With Evaluation of Medico-economic Impacts
- ClinicalTrials.gov ID
- NCT01639820
- Acronym / sponsor ID
- SENTICOL2 / 2008.515
- Conditions
- Uterine Cervical Dysplasia
- Keywords
- Cervical cancer, early stage carcinoma, FIGO IA1 IA2 IB1 IIA, sentinel lymph node biopsy, pelvic lymphadenectomy, Surgery of uterine cervical carcinoma, medico economic impact, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 267 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 13 Jul 2012 (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.
Patients with early cervical cancer are usually treated with radical hysterectomy + pelvic lymph-node dissection. The study randomizes patients in 2 arms. The control arm is the classical surgical treatment including identification of the sentinel nodes, full pelvic lymph-node dissection and radical hysterectomy.
The experimental arm is only sentinel node identification + radical hysterectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Strategy A | Experimental | Procedure: only identification of sentinel nodes (without pelvic lymph-node dissection)Only identification of sentinel nodes (without pelvic lymph-node dissection) |
| Strategy B | Other | Procedure: identification of sentinel nodes + full pelvic lymph-node dissectionIdentification of sentinel nodes + full pelvic lymph-node dissection |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Women 18 years of age or older,
- Absence of contraindication to laparoscopy,
- Uterine cervical carcinoma (every histological type except neuroendocrine),
- Stage IA1 with lymphatic tumor space involvement (LVSI) or IA2 diagnosed on cervical conization; or stage IA2, IB1 or IIA detected by clinical examination, confirmed by biopsy and measured by the MRI, the highest diameter being lower to 4 cm (a preoperative brachytherapy is allowed for tumors 2 to 4 cm in diameter),
- Negative pregnancy test for women able to procreate,
Key exclusion criteria (13 listed)
- Neuroendocrine carcinoma,
- In situ carcinoma or stage IA1 without LVSI,
- Maximal tumoral diameter measured by MRI more than 4 cm,
- Stage IB1 by "down-staging",
- Stage IB2, IIB to IVB, including those who had a response to neoadjuvant treatment (chemotherapy or RT + chemotherapy) ,
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 |
|---|---|---|
| identification of sentinel nodes + full pelvic lymph-node dissectionidentification of sentinel nodes + full pelvic lymph-node dissection | Procedure or surgery | Strategy B |
| only identification of sentinel nodes (without pelvic lymph-node dissection)only identification of sentinel nodes (without pelvic lymph-node dissection) | Procedure or surgery | Strategy A |
Primary outcome
Number of Participants with complications observed in the 2 arms during the per and post-operative period up to 6 months
Time frame: 6 months after surgery
7 secondary outcomes
Score of the questionnaire of quality of life at 30 days, 3 months and 6 months after surgery
Time frame: 30 days, 3 months and 6 months after surgery
the costs of both studied strategies
Time frame: At the surgery until 6 months
the detection rate of the sentinel node technique in the 2 arms
Time frame: Day 1
the false negative rate in the control arm
Time frame: Day 1
the sites of recurrence for each strategy
Time frame: Day 1
Number of patients without 3 years-recurrence for each strategy
Time frame: 3 years after surgery
Number of patient treated by radio chemotherapy because of the presence of micrometastases in the sentinel node
Time frame: 30 days, 3 months and 6 months after surgery
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 19 Dec 2025.
- Results publication: PubMed 25727652Bats AS, Frati A, Mathevet P, Orliaguet I, Querleu D, Zerdoud S, Leblanc E, Gauthier H, Uzan C, Deandreis D, Darai E, Kerrou K, Marret H, Lenain E, Froissart M, Lecuru F. Contribution of lymphoscintigraphy to intraoperative sentinel lymph node detection in early cervical cancer: Analysis of the prospective multicenter SENTICOL cohort. Gynecol Oncol. 2015 May;137(2):264-9. doi: 10.1016/j.ygyno.2015.02.018. Epub 2015 Feb 26.
- Results publication: PubMed 33773275Mathevet P, Lecuru F, Uzan C, Boutitie F, Magaud L, Guyon F, Querleu D, Fourchotte V, Baron M, Bats AS; Senticol 2 group. Sentinel lymph node biopsy and morbidity outcomes in early cervical cancer: Results of a multicentre randomised trial (SENTICOL-2). Eur J Cancer. 2021 May;148:307-315. doi: 10.1016/j.ejca.2021.02.009. Epub 2021 Mar 24.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing identification of sentinel nodes + full pelvic lymph-node dissection and only identification of sentinel nodes (without pelvic lymph-node dissection) in people with Uterine Cervical Dysplasia, run by Hospices Civils de Lyon at 1 site in France.
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 7 inclusion and 13 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 19 Dec 2025. 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 France. 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?
Number of Participants with complications observed in the 2 arms during the per and post-operative period up to 6 months (time frame: 6 months after surgery). 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 NCT01639820, which also lists 2 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 19 Dec 2025.