Non-hematologic CancerNEURISKNCT01799421
Risk Assessment of Febrile Neutropenia and Grade 3-4 Neutropenia in Patients With Non-hematological Cancer Treated With Conventional Chemotherapy
An observational study of Non-hematologic Cancer, run by Asociación para el Fomento de la Investigación y el Desarrollo Integral de la Oncología at 20 sites in Spain.
Trial summary
The purpose of this study is to identify prognostic factors and to develop predictive models of risk of febrile neutropenia and neutropenia grade 3/4 in patients with solid tumors receiving chemotherapy with schemas that have an inherent risk of febrile neutropenia of 10-20%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-hematologic Cancer
- How many people
- 420 participants
- Where
- 20 sitesSpain
- Study dates
- Oct 2011to Dec 2015
- 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 with non-hematologic cancer that will start chemotherapy treatment.
Who may be able to join
- Male or female > 18 years
- Histologically confirmed solid tumor.
- Subjects who have not received chemotherapy and / or radiotherapy in the last 3 months.
- Subject to initiate a chemotherapy (ie, cycle 1, day 1)
- The chemotherapy regimen should have an inherent risk of febrile neutropenia of 10-20%.
- Planning a minimum of 3 cycles chemotherapy.
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- Adequate bone marrow reserve defined by: leukocytes ≥ 3,000 / mm3, platelets ≥ 100.000/mm3; neutrophils ≥ 1,500 / mm3.
- Adequate hepatic and renal function, defined by: bilirubin <1.5 times the normal value, ALT and AST <3 times the normal range (both can be elevated up to 5 times the normal value in patients with known liver metastases); creatinine <1.5 times upper normal value
- ECOG ≤ 2.
- Informed consent
Who cannot join
- Patients under treatment with an investigational treatment.
- Active infection in the last 72 h before starting chemotherapy.
- Indication of chemotherapy dose intensity or chemotherapy included in the risk rating of febrile neutropenia <10% or >20%.
- Patients with concomitant chemoradiotherapy.
- Patients being treated with biological drugs in monotherapy.
- Any other condition causing neutropenia.
- History of bone marrow transplant or stem cells.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Spain20 sites
Hospital Teresa Herrera
A Coruña, A coruña, 15006
Hospital Universitario Albacete
Albacete, Albacete, 02006
Hospital Clínico Universitario San Juan de Alicante
Alicante, Alicante, 03010
Hospital Quirón
Barcelona, Barcelona, 08023
Hospital de Basurto
Basurto, Bilbao, 48013
Hospital San Pedro de Alcántara
Cáceres, Cáceres, 10003
Hospital Dr. Josep Trueta
Girona, Girona, 17007
Hospital Virgen de las Nieves
Granada, Granada, 18014
Hospital de Jerez
Jerez de la Frontera, Cádiz, 11407
Hospital de Lugo
Lugo, Lugo, 27004
Hospital Morales Meseger
Murcia, Murcia, 30008
Complejo Hospitalario de Ourense
Ourense, Ourense, 32005
Hospital de Navarra
Pamplona, Navarre, 31008
Hospital de Donosti
San Sebastián, Guipuzcua, 20080
Hospital de Santa Tecla
Tarragona, Tarragona, 43003
Hospital Virgen de la Salud
Toledo, Toledo, 45004
Hospital Arnau de Vilanova
Valencia, Valencia, 46015
Hospital Universitario Doctor Peset
Valencia, Valencia, 46017
Hospital Clínico de Valladolid
Valladolid, Valladolid, 47005
Hospital Xeral
Vigo, Pontevedra, 36204
About this study
Official title: Predictive Models of Risk Assessment of Febrile Neutropenia and Grade 3-4 Neutropenia in Patients With Non-hematological Cancer Treated With Conventional Chemotherapy.
The purpose of this study is to identify prognostic factors and to develop predictive models of risk of febrile neutropenia and neutropenia grade 3/4 in patients with solid tumors receiving chemotherapy with schemas that have an inherent risk of febrile neutropenia of 10-20%.
- Conditions
- Non-hematologic Cancer
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 |
|---|---|---|
| Non-haematologic cancer | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify predictive models about the risk of febrile neutropenia and neutropenia grade 3/4 in patients with non-hematologic cancer
Measured: 6 months
Secondary outcomes (4)
Occurrence of serious adverse events
Measured: 6 months
Analyze costs to treat febrile neutropenia and neutropenia grade 3/4
Measured: 6 months
Analyze the risk of mortality due to febrile neutropenia and neutropenia grade 3/4 during the chemotherapy treatment
A Cox proportional hazards regression will be used to evaluate the risk of mortality due to febrile neutropenia and neutropenia grade 3/4 during chemotherapy treatment.
Measured: 6 months
Evaluate impact of febrile neutropenia and neutropenia grade 3/4 in treatment compliance
The impact of febrile neutropenia and neutropenia grade 3/4 in treatment compliance (yes/no) will be evaluated using a chi-square test.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2013 (estimated)
- Study startOct 2011
- Primary completionDec 2014
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-hematologic CancerStudies 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
- Prospective
- Enrolment
- 420 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asociación para el Fomento de la Investigación y el Desarrollo Integral de la Oncología
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01799421
- Sponsor's protocol ID
- NEURISK
- Acronym
- NEURISK
- Status last verified
- Nov 2016
- First submitted
- 23 Feb 2013
- Last updated
- 21 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Models of Risk Assessment of Febrile Neutropenia and Grade 3-4 Neutropenia in Patients With Non-hematological Cancer Treated With Conventional Chemotherapy.
- ClinicalTrials.gov ID
- NCT01799421
- Acronym / sponsor ID
- NEURISK / NEURISK
- Conditions
- Non-hematologic Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 420 participants (actual)
- Lead sponsor
- Asociación para el Fomento de la Investigación y el Desarrollo Integral de la OncologíaUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 26 Feb 2013 (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.
The purpose of this study is to identify prognostic factors and to develop predictive models of risk of febrile neutropenia and neutropenia grade 3/4 in patients with solid tumors receiving chemotherapy with schemas that have an inherent risk of febrile neutropenia of 10-20%.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-haematologic cancer | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with non-hematologic cancer that will start chemotherapy treatment.
Key inclusion criteria (10 listed)
- Male or female > 18 years
- Histologically confirmed solid tumor.
- Subjects who have not received chemotherapy and / or radiotherapy in the last 3 months.
- Subject to initiate a chemotherapy (ie, cycle 1, day 1)
- The chemotherapy regimen should have an inherent risk of febrile neutropenia of 10-20%.
Key exclusion criteria (7 listed)
- Patients under treatment with an investigational treatment.
- Active infection in the last 72 h before starting chemotherapy.
- Indication of chemotherapy dose intensity or chemotherapy included in the risk rating of febrile neutropenia <10% or >20%.
- Patients with concomitant chemoradiotherapy.
- Patients being treated with biological drugs in monotherapy.
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
Identify predictive models about the risk of febrile neutropenia and neutropenia grade 3/4 in patients with non-hematologic cancer
Time frame: 6 months
4 secondary outcomes
Occurrence of serious adverse events
Time frame: 6 months
Analyze costs to treat febrile neutropenia and neutropenia grade 3/4
Time frame: 6 months
Analyze the risk of mortality due to febrile neutropenia and neutropenia grade 3/4 during the chemotherapy treatment
Time frame: 6 months
Evaluate impact of febrile neutropenia and neutropenia grade 3/4 in treatment compliance
Time frame: 6 months
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 Nov 2016.
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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.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-hematologic Cancer, run by Asociación para el Fomento de la Investigación y el Desarrollo Integral de la Oncología at 20 sites in Spain.
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 10 inclusion and 7 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 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Spain. 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?
Identify predictive models about the risk of febrile neutropenia and neutropenia grade 3/4 in patients with non-hematologic cancer (time frame: 6 months). 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 Nov 2016.