Endometrial CancerNCT04246580
Evaluation of Indocyanine Green-guided Systematic Pelvic Lymphadenectomy in Endometrial and Cervical Cancer
An observational study of Endometrial Cancer and Cervical Cancer, run by Università degli Studi dell'Insubria.
Trial summary
The lymph nodes involvement is one of the most important prognostic factors in endometrial (EC) and cervical cancer (CC). Indeed, the lymph node involvement in cancer patients modifies the International Federation of Gynecology and Obstetrics (FIGO) stage and plays a pivotal role in the choice of the adjuvant therapy. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Endometrial Cancer, Cervical Cancer
- What is being tested?
- Indocyanine green-guided systematic pelvic lymphadenectomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 230 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Nov 2022
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women affected by endometrial or cervical cancer undergoing laparoscopic/robotic systematic pelvic lymphadenectomy (with or without previous injection of indocyanine green tracer within the uterine cervix).
Who may be able to join
- Women affected by endometrial or cervical cancer
- Laparoscopic/robotic surgical approach with systematic pelvic lymphadenectomy.
Who cannot join
- Women undergoing open surgery (laparotomy) for the surgical management of endometrial or cervical cancer.
About this study
The lymph nodes involvement is one of the most important prognostic factors in endometrial (EC) and cervical cancer (CC). Indeed, the lymph node involvement in cancer patients modifies the International Federation of Gynecology and Obstetrics (FIGO) stage and plays a pivotal role in the choice of the adjuvant therapy.
Since the modern imaging techniques are not yet able to accurately detect lymph nodes metastasis, pelvic systematic lymphadenectomy has still an important role and it still represents the gold standard in EC and CC. The sentinel lymph node (SLN) biopsy, which is a standard practice in breast cancer and melanoma, is often used in some early stage gynaecological cancers such as EC and CC.
Read more
Indocyanine green (ICG) is the most used tracer for the detection of SLN in gynaecological cancer, especially in laparoendoscopic setting. ICG allows a complete visualization of the lymphatic drainage and, for this reason, it may be used even in systematic pelvic lymphadenectomy to guide the surgeon during the procedure. Several studies have demonstrated an advantage of the ICG-guided lymphadenectomy in other types of cancers, showing a higher number of lymph nodes removed with this technique when compared to standard lymphadenectomy (without ICG).
To date, there is no published study about ICG-guided systematic pelvic lymphadenectomy in EC and CC. In this scenario, the aim of this study will be to compare systematic ICG-guided pelvic lymphadenectomy and standard lymphadenectomy in EC and CC.
- Conditions
- Endometrial Cancer, Cervical Cancer
- Being tested
- Indocyanine green-guided systematic pelvic lymphadenectomy
- Keywords
- Indocyanine green, Pelvic lymphadenectomy
- Medical subject headings
- Endometrial Neoplasms, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indocyanine green-guided systematic pelvic lymphadenectomyProcedure or surgery
Injection of Indocyanine green within the uterine cervix before to perform laparoscopic/robotic systematic pelvic lymphadenectomy
| Study group | Role | What they receive |
|---|---|---|
| Indocyanine green | Women with endometrial and cervical cancer undergoing indocyanine green-guided systematic pelvic lymphadenectomy by laparoscopy or robotic surgery Receives: Procedure: Indocyanine green-guided systematic pelvic lymphadenectomy | |
| Control | Women with endometrial and cervical cancer undergoing systematic pelvic lymphadenectomy by laparoscopy or robotic surgery without the use of indocyanine green tracer injection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retrieved lymph nodes
Number of retrieved lymph nodes after laparoscopic/robotic systematic pelvic lymphadenectomy
Measured: At the moment of the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2020
- Study startJan 2014
- Primary completionNov 2018
- Study completionNov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endometrial CancerStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università degli Studi dell'Insubria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Simone Laganà, Università degli Studi dell'Insubria
- Investigators
- Benito Chiofalo, M.D., Principal investigator, Regina Elena National Cancer Institute, Rome, ItalyAntonio Simone Laganà, M.D., Ph.D., Study chair, Università degli Studi dell'Insubria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04246580
- Sponsor's protocol ID
- GREEN-1
- Status last verified
- Jan 2023
- First submitted
- 26 Jan 2020
- Last updated
- 31 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chiofalo B, Lagana AS, Ghezzi F, Certelli C, Casarin J, Bruno V, Sperduti I, Chiantera V, Peitsidis P, Vizza E. Beyond Sentinel Lymph Node: Outcomes of Indocyanine Green-Guided Pelvic Lymphadenectomy in Endometrial and Cervical Cancer. Int J Environ Res Public Health. 2023 Feb 16;20(4):3476. doi: 10.3390/ijerph20043476.
PubMed 36834170
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Indocyanine Green-guided Systematic Pelvic Lymphadenectomy in Endometrial and Cervical Cancer
- ClinicalTrials.gov ID
- NCT04246580
- Acronym / sponsor ID
- GREEN-1
- Conditions
- Endometrial Cancer, Cervical Cancer
- Keywords
- Indocyanine green, Pelvic lymphadenectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Università degli Studi dell'InsubriaUniversity, hospital or other
- Study start
- Jan 2014 (actual)
- Primary completion
- Nov 2018 (actual)
- Study completion
- Nov 2022 (actual)
- First posted
- 29 Jan 2020 (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.
The lymph nodes involvement is one of the most important prognostic factors in endometrial (EC) and cervical cancer (CC). Indeed, the lymph node involvement in cancer patients modifies the International Federation of Gynecology and Obstetrics (FIGO) stage and plays a pivotal role in the choice of the adjuvant therapy.
Since the modern imaging techniques are not yet able to accurately detect lymph nodes metastasis, pelvic systematic lymphadenectomy has still an important role and it still represents the gold standard in EC and CC. The sentinel lymph node (SLN) biopsy, which is a standard practice in breast cancer and melanoma, is often used in some early stage gynaecological cancers such as EC and CC.
Indocyanine green (ICG) is the most used tracer for the detection of SLN in gynaecological cancer, especially in laparoendoscopic setting. ICG allows a complete visualization of the lymphatic drainage and, for this reason, it may be used even in systematic pelvic lymphadenectomy to guide the surgeon during the procedure. Several studies have demonstrated an advantage of the ICG-guided lymphadenectomy in other types of cancers, showing a higher number of lymph nodes removed with this technique when compared to standard lymphadenectomy (without ICG).
To date, there is no published study about ICG-guided systematic pelvic lymphadenectomy in EC and CC. In this scenario, the aim of this study will be to compare systematic ICG-guided pelvic lymphadenectomy and standard lymphadenectomy in EC and CC.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Indocyanine green | – | Procedure: Indocyanine green-guided systematic pelvic lymphadenectomyWomen with endometrial and cervical cancer undergoing indocyanine green-guided systematic pelvic lymphadenectomy by laparoscopy or robotic surgery |
| Control | – | –Women with endometrial and cervical cancer undergoing systematic pelvic lymphadenectomy by laparoscopy or robotic surgery without the use of indocyanine green tracer injection. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women affected by endometrial or cervical cancer undergoing laparoscopic/robotic systematic pelvic lymphadenectomy (with or without previous injection of indocyanine green tracer within the uterine cervix).
Key inclusion criteria (2 listed)
- Women affected by endometrial or cervical cancer
- Laparoscopic/robotic surgical approach with systematic pelvic lymphadenectomy.
Key exclusion criteria (1 listed)
- Women undergoing open surgery (laparotomy) for the surgical management of endometrial or cervical cancer.
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 |
|---|---|---|
| Indocyanine green-guided systematic pelvic lymphadenectomyInjection of Indocyanine green within the uterine cervix before to perform laparoscopic/robotic systematic pelvic lymphadenectomy | Procedure or surgery | Indocyanine green |
Primary outcome
Retrieved lymph nodes
Time frame: At the moment of the surgery
Number of retrieved lymph nodes after laparoscopic/robotic systematic pelvic lymphadenectomy
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 31 Jan 2023.
- Derived from this study: PubMed 36834170Chiofalo B, Lagana AS, Ghezzi F, Certelli C, Casarin J, Bruno V, Sperduti I, Chiantera V, Peitsidis P, Vizza E. Beyond Sentinel Lymph Node: Outcomes of Indocyanine Green-Guided Pelvic Lymphadenectomy in Endometrial and Cervical Cancer. Int J Environ Res Public Health. 2023 Feb 16;20(4):3476. doi: 10.3390/ijerph20043476.
- Individual participant dataSharing planned: No
Related trials for Endometrial Cancer
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Active, not recruitingPhase 3
Endometrial Cancer Patientes MMR Deficient Comparing Chemotherapy vs Dostarlimab in First Line
Endometrial Cancer
RecruitingPhase 3
Testing the Addition of an Antiangiogenic Drug (Bevacizumab) to Chemotherapy (Carboplatin and Paclitaxel) Combined With Immunotherapy (Pembrolizumab) for pMMR, TP53 Mutated Endometrial Cancer
Advanced Endometrial Carcinoma, Recurrent Endometrial Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 3
Impact of Sentinel Lymph Node Mapping on Patient Reported Lower Extremity Limb Dysfunction in Stage I Endometrial Cancer
Stage I Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8
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.
Benito Chiofalo, M.D. principal investigator
Regina Elena National Cancer Institute, Rome, Italy
Antonio Simone Laganà, M.D., Ph.D. study chair
Università degli Studi dell'Insubria
Questions about this trial
What is this clinical trial studying?
An observational study of Endometrial Cancer and Cervical Cancer, run by Università degli Studi dell'Insubria.
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 2 inclusion and 1 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 31 Jan 2023. 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?
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?
Retrieved lymph nodes (time frame: At the moment of the 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 NCT04246580, which also lists 1 linked publication.
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 31 Jan 2023.