Uterine Cervical NeoplasmsSENTIREC INCT02825355
Sentinel Node Mapping in Women With Cervical and Endometrial Cancer
An observational study of Uterine Cervical Neoplasms and Uterine Neoplasms, run by University of Southern Denmark at 3 sites in Denmark.
Trial summary
This study aims to evaluate the effect of SLN mapping on the incidence and severity of lymphedema in women with early stage cervical and endometrial cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Uterine Cervical Neoplasms, Uterine Neoplasms
- How many people
- 512 participants
- Where
- 3 sitesDenmark
- Study dates
- 27 Feb 2017to 1 May 2022
- How long will I take part?
- 3 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: See above in eligibility criteria.
Who may be able to join
- Study IA: Cervical carcinoma, FIGO stage IB1, cervical tumour size < 2 cm
- Study IB: Endometrial adenocarcinoma, presumed FIGO stage I, low- and intermediate risk: Type 1 grade 1 + 2, > 50% myometrial invasion
Who cannot join
- Prior PL
- Known allergy towards ICG and/or iodine (ICG contains 5% sodium iodine)
- Women included in other studies affecting outcome-measures of the present study
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
Rigshospitalet
Copenhagen, 2100
Herlev Hospital
Herlev, 2730
Odense University Hospital
Odense, 5000
About this study
Official title: Sentinel Node Mapping With Robotic Assisted Near Infra-red Fluorescent Imaging in Women With Cervical and Endometrial Cancer
This study aims to evaluate the effect of SLN mapping on the incidence and severity of lymphedema in women with early stage cervical and endometrial cancer.
- Conditions
- Uterine Cervical Neoplasms, Uterine Neoplasms
- Keywords
- robotic surgery procedure, indocyanine green, sentinel lymph node mapping
- Medical subject headings
- Uterine Cervical Neoplasms, Uterine Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with cervical cancer | All patients receive sentinel node mapping as the conventional treatment. | |
| Patients with endometrial cancer | All patients receive sentinel node mapping as the conventional treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of lymphedema
Incidence of lymphedema will be assessed using patient reported outcome measures.
Measured: 3 years
Severity of lymphedema
Severity of lymphedema will be assessed using patient reported outcome measures.
Measured: 3 years
Secondary outcomes (2)
Detection rate of sentinel lymph node
Detection of sentinel lymph node per patient, per heme-pelvis and bilaterally
Measured: 2 years
Mapping of SLN in different types of lymph node stations
Mapping of SLN in areas outside the normal area of pelvic lymphadenectomy
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 posted7 Jul 2016 (estimated)
- Study start27 Feb 2017
- Primary completion1 May 2022
- Study completion1 May 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 Uterine Cervical NeoplasmsStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe 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
- 512 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Odense University Hospital, Danish Cancer Society
- Responsible party
- Principal investigator, Sara Sponholtz, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02825355
- Sponsor's protocol ID
- SDUSF12015163 1 (198)
- Acronym
- SENTIREC I
- Status last verified
- May 2022
- First submitted
- 23 Jun 2016
- Last updated
- 24 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bjornholt SM, Sponholtz SE, Markauskas A, Froding LP, Larsen CR, Fuglsang K, Schledermann D, Mogensen O, Jensen PT. Sentinel lymph node mapping for endometrial and cervical cancer in Denmark. Dan Med J. 2021 Mar 24;68(4):A11200886.
PubMed 33829991
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sentinel Node Mapping With Robotic Assisted Near Infra-red Fluorescent Imaging in Women With Cervical and Endometrial Cancer
- ClinicalTrials.gov ID
- NCT02825355
- Acronym / sponsor ID
- SENTIREC I / SDUSF12015163 1 (198)
- Conditions
- Uterine Cervical Neoplasms, Uterine Neoplasms
- Keywords
- robotic surgery procedure, indocyanine green, sentinel lymph node mapping
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 512 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Odense University Hospital, Danish Cancer Society
- Study start
- 27 Feb 2017 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 7 Jul 2016 (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.
This study aims to evaluate the effect of SLN mapping on the incidence and severity of lymphedema in women with early stage cervical and endometrial cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with cervical cancer | – | –All patients receive sentinel node mapping as the conventional treatment. |
| Patients with endometrial cancer | – | –All patients receive sentinel node mapping as the conventional treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- See above in eligibility criteria.
Key inclusion criteria (2 listed)
- Study IA: Cervical carcinoma, FIGO stage IB1, cervical tumour size < 2 cm
- Study IB: Endometrial adenocarcinoma, presumed FIGO stage I, low- and intermediate risk: Type 1 grade 1 + 2, > 50% myometrial invasion
Key exclusion criteria (3 listed)
- Prior PL
- Known allergy towards ICG and/or iodine (ICG contains 5% sodium iodine)
- Women included in other studies affecting outcome-measures of the present study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of lymphedema
Time frame: 3 years
Incidence of lymphedema will be assessed using patient reported outcome measures.
Severity of lymphedema
Time frame: 3 years
Severity of lymphedema will be assessed using patient reported outcome measures.
2 secondary outcomes
Detection rate of sentinel lymph node
Time frame: 2 years
Mapping of SLN in different types of lymph node stations
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 24 May 2022.
- Derived from this study: PubMed 33829991Bjornholt SM, Sponholtz SE, Markauskas A, Froding LP, Larsen CR, Fuglsang K, Schledermann D, Mogensen O, Jensen PT. Sentinel lymph node mapping for endometrial and cervical cancer in Denmark. Dan Med J. 2021 Mar 24;68(4):A11200886.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Uterine Cervical Neoplasms and Uterine Neoplasms, run by University of Southern Denmark at 3 sites in Denmark.
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 3 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 24 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. 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?
Incidence of lymphedema (time frame: 3 years). The study lists 2 primary outcomes in all. 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 NCT02825355, 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 24 May 2022.