Prostatic NeoplasmsNCT01296217
Sentinel Lymph Node Detection in Prostate Surgery by Laparoscopy
A study testing lymph nod detection in people with Prostatic Neoplasms, run by Centre René Gauducheau at 1 site in France.
Trial summary
In this study the investigators want to determine if the detection of lymph node is applicable in prostatectomy by laparoscopy. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostatic Neoplasms
- What is being tested?
- lymph nod detection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- Start not givento not given
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age> 18 years
- Diagnosis of invasive cancer of the prostate (T1 or T2 or T3)
- PSA ≥ 4,
- Gleason ≥ 6
- No treatment prior to surgery
- Indication of lymphadenectomy by coeliscopique
- ECOG or Karnofsky index 2
- Patient information and signed informed consent
Who cannot join
- neoadjuvant hormone therapy
- Interventions prior pelvic
- Patients who received anterior resection of part of prostate
- Patient or denied having an altered mental status
- Any contre indication to laparoscopy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "Evaluation of the Sentinel Lymph Node Technic of the Prostate by Laparoscopy"
In this study the investigators want to determine if the detection of lymph node is applicable in prostatectomy by laparoscopy.
- Conditions
- Prostatic Neoplasms
- Being tested
- lymph nod detection
- Keywords
- Patients with infiltrant prostatic carcinoma
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lymph nod detectionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| lymph nod detection | Experimental | Not described Receives: Procedure: lymph nod detection |
What is being measured
The primary outcome is the main question the study is designed to answer.
detection rate and false-negative rate for the sentinel lymph node detection
Measured: The day of at laparoscopy (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic NeoplasmsStudies 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre René Gauducheau
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01296217
- Sponsor's protocol ID
- BRD 07/11-M
- Status last verified
- Feb 2011
- First submitted
- 11 Feb 2011
- Last updated
- 4 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Evaluation of the Sentinel Lymph Node Technic of the Prostate by Laparoscopy"
- ClinicalTrials.gov ID
- NCT01296217
- Acronym / sponsor ID
- BRD 07/11-M
- Conditions
- Prostatic Neoplasms
- Keywords
- Patients with infiltrant prostatic carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Centre René GauducheauUniversity, hospital or other
- First posted
- 15 Feb 2011 (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.
In this study the investigators want to determine if the detection of lymph node is applicable in prostatectomy by laparoscopy.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lymph nod detection | Experimental | Procedure: lymph nod detection |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age> 18 years
- Diagnosis of invasive cancer of the prostate (T1 or T2 or T3)
- PSA ≥ 4,
- Gleason ≥ 6
- No treatment prior to surgery
Key exclusion criteria (5 listed)
- neoadjuvant hormone therapy
- Interventions prior pelvic
- Patients who received anterior resection of part of prostate
- Patient or denied having an altered mental status
- Any contre indication to laparoscopy
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 |
|---|---|---|
| lymph nod detection | Procedure or surgery | lymph nod detection |
Primary outcome
detection rate and false-negative rate for the sentinel lymph node detection
Time frame: The day of at laparoscopy (Day 1)
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 4 Mar 2011.
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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 lymph nod detection in people with Prostatic Neoplasms, run by Centre René Gauducheau 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 8 inclusion and 5 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 4 Mar 2011. 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?
detection rate and false-negative rate for the sentinel lymph node detection (time frame: The day of at laparoscopy (Day 1)). 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 4 Mar 2011.