Sentinel Lymph NodeNCT06169787
Sentinel Lymph Nodes Biopsy in Cervical Cancer
An observational study of Sentinel Lymph Node, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial summary
This study aims to compare sentinel lymph nodes biopsy versus comprehensive lymphadenectomy in patients with early stage cervical cancer who underwent radical hysterectomy. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Sentinel Lymph Node
- What is being tested?
- sentinel lymph node biopsy and comprehensive pelvic lymphadenectomy
- Type of treatment
- Surgery or procedure
- How many people
- 70 participants
- Where
- 1 siteTaiwan
- Study dates
- 14 Oct 2023to 30 Sep 2024
- 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 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women aged 20 and above with early stage cervical cancer, who received surgical treatment
Who may be able to join
- Women aged 20 and above with clinical FIGO stage I-IIA cervical cancer
Who cannot join
- Women did not receive surgical treatment
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital
Banqiao District, New Taipei, 22050
About this study
Official title: Sentinel Lymph Nodes Biopsy Versus Lymphadenectomy in Cervical Cancer
This study aims to compare sentinel lymph nodes biopsy versus comprehensive lymphadenectomy in patients with early stage cervical cancer who underwent radical hysterectomy.
- Conditions
- Sentinel Lymph Node
- Being tested
- sentinel lymph node biopsy, comprehensive pelvic lymphadenectomy
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
sentinel lymph node biopsy
comprehensive pelvic lymphadenectomyProcedure or surgery
comprehensive pelvic lymphadenectomy
| Study group | Role | What they receive |
|---|---|---|
| Sentinel Lymph Node | Sentinel lymph node biopsy in patients with early stage cervical cancer Receives: Procedure: sentinel lymph node biopsy | |
| Lymphadenectomy | Comprehensive lymphadenectomy in patients with early stage cervical cancer Receives: Procedure: comprehensive pelvic lymphadenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression free survival
progression free survival between these two groups
Measured: 5 years
Secondary outcomes (2)
overall survival
overall survival between these two groups
Measured: 5 years
Number of dissected lymph node
Number of dissected lymph node between these two groups
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2023
- Study start14 Oct 2023
- Primary completion31 Aug 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sentinel Lymph NodeStudies 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
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheng-Mou Hsiao, Far Eastern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06169787
- Sponsor's protocol ID
- 112154-E
- Status last verified
- Apr 2024
- First submitted
- 14 Oct 2023
- Last updated
- 17 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sentinel Lymph Nodes Biopsy Versus Lymphadenectomy in Cervical Cancer
- ClinicalTrials.gov ID
- NCT06169787
- Acronym / sponsor ID
- 112154-E
- Conditions
- Sentinel Lymph Node
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- 14 Oct 2023 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 14 Dec 2023 (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.
This study aims to compare sentinel lymph nodes biopsy versus comprehensive lymphadenectomy in patients with early stage cervical cancer who underwent radical hysterectomy.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sentinel Lymph Node | – | Procedure: sentinel lymph node biopsySentinel lymph node biopsy in patients with early stage cervical cancer |
| Lymphadenectomy | – | Procedure: comprehensive pelvic lymphadenectomyComprehensive lymphadenectomy in patients with early stage cervical cancer |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women aged 20 and above with early stage cervical cancer, who received surgical treatment
Key inclusion criteria (1 listed)
- Women aged 20 and above with clinical FIGO stage I-IIA cervical cancer
Key exclusion criteria (1 listed)
- Women did not receive surgical treatment
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 biopsysentinel lymph node biopsy | Procedure or surgery | Sentinel Lymph Node |
| comprehensive pelvic lymphadenectomycomprehensive pelvic lymphadenectomy | Procedure or surgery | Lymphadenectomy |
Primary outcome
progression free survival
Time frame: 5 years
progression free survival between these two groups
2 secondary outcomes
overall survival
Time frame: 5 years
Number of dissected lymph node
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2024.
- Individual participant dataSharing planned: No
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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?
An observational study of Sentinel Lymph Node, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
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 1 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: status not confirmed, as of the sponsor's last update on 17 Jun 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 Taiwan. 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?
Results are not available in the source record.
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?
progression free survival (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jun 2024.