Recurrence TumorNCT04656769
Analgesia aNd caNcer recUrrence Lung cAncer Resection
An observational study of Recurrence Tumor and Opioid Use, Unspecified, run by University of Turin, Italy at 1 site in Italy.
Trial summary
The choice of analgesia after cancer surgery may play a role in the onset of recurrence, particularly opioids seem to play a role in the immune system by promoting cancer cell proliferation and migration. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrence Tumor, Opioid Use, Unspecified, Analgesia
- What is being tested?
- Peridural analgesia
- Type of treatment
- Surgery or procedure
- How many people
- 382 participants
- Where
- 1 siteItaly
- Study dates
- 17 Dec 2018to 30 Nov 2020
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent lung resection for Stage I NSCLC between January 2005 and December 2012
Who may be able to join
- Age ≥ 18 yrs
- Patients who underwent lung resection for Stage I NSCLC between January 2005 and December 2012
Who cannot join
- Age<18aa
- Pregnancy
- Day hospital patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Analgesia on Cancer Recurrence and Mortality Within Five Years After Stage I Non-Small Cell Lung Cancer Resection
The choice of analgesia after cancer surgery may play a role in the onset of recurrence, particularly opioids seem to play a role in the immune system by promoting cancer cell proliferation and migration. Based on this consideration, our aim was to assess the impact of perioperative analgesia's choice on cancer recurrence after curative surgery for Stage I Non-Small Cell Lung Cancer. The investigators retrospectively reviewed the records of patients who underwent lung resection for Stage I NSCLC between January 2005 and December 2012. Patients received analgesia either by peridural (PERI group) or, in case of patient refusal or failure in catheter positioning, intravenous analgesia with opioids (EV group). Follow-up was concluded in August 2019. The five-year cumulative incidence of recurrence and the overall survival were evaluated and adjusted with a propensity score matching methodology.
- Conditions
- Recurrence Tumor, Opioid Use, Unspecified, Analgesia, Thoracic Surgery
- Being tested
- Peridural analgesia
- Keywords
- Recurrence tumor, Opioid use, Analgesia, thoracic surgery
- Medical subject headings
- Recurrence, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peridural analgesiaProcedure or surgery
We attempted to evaluate the effectiveness of peridural analgesia through cancer survival and recurrence outcomes.
| Study group | Role | What they receive |
|---|---|---|
| PERI group | Not described Receives: Procedure: Peridural analgesia | |
| EV group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
cumulative incidence of recurrence and the overall survival
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 posted7 Dec 2020
- Study start17 Dec 2018
- Primary completion1 Apr 2020
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrence TumorStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 382 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luca Brazzi, University of Turin, Italy
- Investigators
- Luca Brazzi, Professor, Study chair, University of TorinoGiulio L Rosboch, MD, Principal investigator, A.O.U. Città della Salute e della ScienzaIlaria De Domenici, MD, Study director, University of TorinoEdoardo Ceraolo, MD, Principal investigator, A.O.U. Città della Salute e della Scienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04656769
- Sponsor's protocol ID
- ANNULAR
- Status last verified
- Dec 2020
- First submitted
- 30 Nov 2020
- Last updated
- 21 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Analgesia on Cancer Recurrence and Mortality Within Five Years After Stage I Non-Small Cell Lung Cancer Resection
- ClinicalTrials.gov ID
- NCT04656769
- Acronym / sponsor ID
- ANNULAR
- Conditions
- Recurrence Tumor, Opioid Use, Unspecified, Analgesia, Thoracic Surgery
- Keywords
- Recurrence tumor, Opioid use, Analgesia, thoracic surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 382 participants (actual)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- 17 Dec 2018 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 7 Dec 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 choice of analgesia after cancer surgery may play a role in the onset of recurrence, particularly opioids seem to play a role in the immune system by promoting cancer cell proliferation and migration. Based on this consideration, our aim was to assess the impact of perioperative analgesia's choice on cancer recurrence after curative surgery for Stage I Non-Small Cell Lung Cancer. The investigators retrospectively reviewed the records of patients who underwent lung resection for Stage I NSCLC between January 2005 and December 2012. Patients received analgesia either by peridural (PERI group) or, in case of patient refusal or failure in catheter positioning, intravenous analgesia with opioids (EV group). Follow-up was concluded in August 2019. The five-year cumulative incidence of recurrence and the overall survival were evaluated and adjusted with a propensity score matching methodology.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PERI group | – | Procedure: Peridural analgesia |
| EV group | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent lung resection for Stage I NSCLC between January 2005 and December 2012
Key inclusion criteria (2 listed)
- Age ≥ 18 yrs
- Patients who underwent lung resection for Stage I NSCLC between January 2005 and December 2012
Key exclusion criteria (3 listed)
- Age<18aa
- Pregnancy
- Day hospital patients
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 |
|---|---|---|
| Peridural analgesiaWe attempted to evaluate the effectiveness of peridural analgesia through cancer survival and recurrence outcomes. | Procedure or surgery | PERI group |
Primary outcome
cumulative incidence of recurrence and the overall survival
Time frame: 5 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 21 Dec 2020.
Related trials for Recurrence Tumor
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 1/2
The Safety and Efficacy of Daratumumab in Patients With Refractory Aplastic Anemia
Aplastic Anemia, Refractory
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.
Luca Brazzi, Professor study chair
University of Torino
Giulio L Rosboch, MD principal investigator
A.O.U. Città della Salute e della Scienza
Ilaria De Domenici, MD study director
University of Torino
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 Recurrence Tumor and Opioid Use, Unspecified, run by University of Turin, Italy at 1 site in Italy.
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 21 Dec 2020. 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 Italy. 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?
cumulative incidence of recurrence and the overall 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 21 Dec 2020.