CancerNCT03575416
Cancer Anesthesia and Frailty
An observational study of Cancer and Anesthesia, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 1 site in Italy.
Trial summary
Subjects undergoing cancer related surgery at the Fondazione IRCCS Istituto Nazionale dei Tumori - Milano will be consecutively recruited. Data regarding presence of co-morbidities, frailty, cancer staging, and inflammatory status (CRP protein measurement) will be collected preoperatively. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cancer, Anesthesia, Fragility
- How many people
- 500 participants
- Where
- 1 siteItaly
- Study dates
- 3 Jul 2018to 1 Nov 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Prospective cohort of subjects undergoing cancer related surgery
Inclusion Criteria: Subjects undergoing cancer related surgery at the Fondazione IRCSS Istituto Nazionale dei Tumori, Milano
Exclusion Criteria: Day case surgery
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Fondazione IRCSS Istituto Nazionale dei Tumori
Milan, MI, 20133
Franco Valenza, MD, +39022390 ext. 2282, franco.valenza@istitutotumori.mi.i.it
About this study
Official title: Prevalence of Multi-morbid Frailty in a Cohort of Subjects Undergoing Cancer Related Surgery
Subjects undergoing cancer related surgery at the Fondazione IRCCS Istituto Nazionale dei Tumori - Milano will be consecutively recruited. Data regarding presence of co-morbidities, frailty, cancer staging, and inflammatory status (CRP protein measurement) will be collected preoperatively. Intra-operative data collection will comprehend type and duration of surgery, kind of anesthesia, complications. In-hospital mortality will be considered as the primary endpoint, while secondary outcome measures will be duration of hospital stay and admission to intensive care.
Read the detailed description
A prospective data collection of pre-intra and postoperative variables will be collected in a cohort of subjects undergoing cancer relate surgery at the Fondazione IRCCS Istituto Nazionale dei Tumori, Milano.
BEFORE SURGERY Subjects will be stratified before surgery according to the following three main clusters: 1) Systemic inflammation: baseline levels of C Reactive Protein; 2) Cancer staging: TNM will be taken into account, together with the type of cancer, previous radio or chemo therapy, and planned/performed surgical procedure; 3) Frailty: subjects will be stratified according to their overall status, taking into account elements of frailty. Co-existing diseases such as diabetes, hypertension, cardiac heart failure, acute myocardial infarction, chronic obstructive disease/asthma, kidney or liver disease (past or present) will be considered. Functional status will be assessed by means of ASA, ECOG status and Possum scores. Frailty will be explored using the mFI and G8 score, the WHO scale, and considering age. Absolute BMI and loss of weight will be used to assess malnutrition.
DURING SURGERY Duration and type of surgery, kind of anesthesia and intra-operative complications will be considered.
AFTER SURGERY Hospital mortality, length of stay, and admission to intensive care will be considered as outcome measures. Major complications, such as myocardial infarction, arrhythmia, cardio circulatory arrest, shock, stroke, pulmonary embolism, kidney failure, delirium, pneumonia or SSI will also be considered.
- Conditions
- Cancer, Anesthesia, Fragility
- Medical subject headings
- Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
In-hospital mortality
Measured: 30 days
Secondary outcomes (2)
Duration of hospital stay
Measured: 30 days
Admission to intensive care.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2018
- Study start3 Jul 2018
- Primary completion1 Sep 2018 (estimated)
- Study completion1 Nov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoThe 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
- 500 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Franco Valenza, MD, Principal investigator, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03575416
- Sponsor's protocol ID
- INT 100-18
- Status last verified
- Jul 2018
- First submitted
- 21 Jun 2018
- Last updated
- 11 Jul 2018
- 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 11 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Multi-morbid Frailty in a Cohort of Subjects Undergoing Cancer Related Surgery
- ClinicalTrials.gov ID
- NCT03575416
- Acronym / sponsor ID
- INT 100-18
- Conditions
- Cancer, Anesthesia, Fragility
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoUniversity, hospital or other
- Study start
- 3 Jul 2018 (actual)
- Primary completion
- 1 Sep 2018 (estimated)
- Study completion
- 1 Nov 2018 (estimated)
- First posted
- 2 Jul 2018 (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.
Subjects undergoing cancer related surgery at the Fondazione IRCCS Istituto Nazionale dei Tumori - Milano will be consecutively recruited. Data regarding presence of co-morbidities, frailty, cancer staging, and inflammatory status (CRP protein measurement) will be collected preoperatively. Intra-operative data collection will comprehend type and duration of surgery, kind of anesthesia, complications. In-hospital mortality will be considered as the primary endpoint, while secondary outcome measures will be duration of hospital stay and admission to intensive care.
Detailed description
A prospective data collection of pre-intra and postoperative variables will be collected in a cohort of subjects undergoing cancer relate surgery at the Fondazione IRCCS Istituto Nazionale dei Tumori, Milano.
BEFORE SURGERY Subjects will be stratified before surgery according to the following three main clusters: 1) Systemic inflammation: baseline levels of C Reactive Protein; 2) Cancer staging: TNM will be taken into account, together with the type of cancer, previous radio or chemo therapy, and planned/performed surgical procedure; 3) Frailty: subjects will be stratified according to their overall status, taking into account elements of frailty. Co-existing diseases such as diabetes, hypertension, cardiac heart failure, acute myocardial infarction, chronic obstructive disease/asthma, kidney or liver disease (past or present) will be considered. Functional status will be assessed by means of ASA, ECOG status and Possum scores. Frailty will be explored using the mFI and G8 score, the WHO scale, and considering age. Absolute BMI and loss of weight will be used to assess malnutrition.
DURING SURGERY Duration and type of surgery, kind of anesthesia and intra-operative complications will be considered.
AFTER SURGERY Hospital mortality, length of stay, and admission to intensive care will be considered as outcome measures. Major complications, such as myocardial infarction, arrhythmia, cardio circulatory arrest, shock, stroke, pulmonary embolism, kidney failure, delirium, pneumonia or SSI will also be considered.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Prospective cohort of subjects undergoing cancer related surgery
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
In-hospital mortality
Time frame: 30 days
2 secondary outcomes
Duration of hospital stay
Time frame: 30 days
Admission to intensive care.
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2018.
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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.
Franco Valenza, MD principal investigator
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
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 Cancer and Anesthesia, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jul 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Franco Valenza, MD (+39022390 ext. 2282, franco.valenza@istitutotumori.mi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-hospital mortality (time frame: 30 days). 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 11 Jul 2018.