Chemotherapy-induced NeutropeniaNCT03701841
Efficacy, Safety and Cost-effectiveness of PEG-rhG-CSF for Primary vs Secondary Prophylaxis
An observational study of Chemotherapy-induced Neutropenia, run by Anhui Provincial Hospital at 1 site in China.
Trial summary
This trial is a multicenter, non-interventional, registered real-world clinical study. Based on available evidence and recommendations of guidelines, tumor patients with high risk of FN and eligible for all enrollment criteria were recruited into primary prophylaxis of PEG-rhG-CSF or secondary prophylaxis of… Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Chemotherapy-induced Neutropenia
- What is being tested?
- PEG-rhG-CSF
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- Oct 2018to Dec 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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with cancer planning for chemotherapy assessed with high risk of febrile neutropenia (FN) according to NCCN and ASCO guidelines are recruited, receiving primary or secondary prophylaxis of PEG-rhG-CSF according to real-world clinical pathway in local cancer center for at least 4 cycles of chemotherapy.
Who may be able to join
- Before the start of the study, all patients have been fully understood the research and the must sign the informed consent
- Aged 13 years or older
- accept at least 4 cycles of chemotherapy
- ECOG PS 0-2
- expected survival time ≥ 3 months
- with -high risk of FN according to researchers
Who cannot join
- accepted stem cell or bone marrow transplant
- undergoing any other clinical trial
- uncontrolled infection, temperature≥38℃
- per-week scheme chemotherapy
- severe and uncontrolled diabetes
- People with allergic diseases or allergies, or who are allergic to this or other genetically engineered Escherichia coli-derived biological products
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- Suspected or confirmed drug use, drug abuse, alcoholics
- Severe mental or neurological disorders affecting informed consent and/or adverse effect presentation or observation
- Severe heart, kidney, liver and other important organs chronic diseases
- Pregnancy or lactation in women or women with gestation detection positive before the first time using drug
- Patients who have fertility but are unwilling to receive contraception or partners are not willing to accept contraceptives
- The investigator believes that the patient's condition is not suitable for this clinical study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy, Safety and Cost-effectiveness of PEG-rhG-CSF for Primary Prophylaxis Versus Secondary Prophylaxis of Chemotherapy Induced Neutropenia in Patients Receiving Chemotherapy With High-risk FN: a Real World Study
This trial is a multicenter, non-interventional, registered real-world clinical study. Based on available evidence and recommendations of guidelines, tumor patients with high risk of FN and eligible for all enrollment criteria were recruited into primary prophylaxis of PEG-rhG-CSF or secondary prophylaxis of PEG-rhG-CSF according to the real-world clinical pathway without randomization. All patients need to receive at least 2 cycles of PEG-rhG-CSF prophylaxis. Researchers will record the incidence of FN, RDI, FN-related hospitalization, antibiotic use, direct medical care and indirect medical care cost under the real clinical conditions, and assess the efficacy, safety and cost-effectiveness of PEG-rhG-CSF primary prophylaxis versus secondary prophylaxis through sub-group analysis and exploratory research.
Read the detailed description
Patients with cancer planning for chemotherapy assessed with high risk of febrile neutropenia (FN) according to NCCN and ASCO guidelines are recruited, receiving primary or secondary prophylaxis of PEG-rhG-CSF according to real-world clinical pathway in local cancer center for at least 4 cycles of chemotherapy. The primary outcome is the incidence of FN rate and proportion of patients completing chemotherapy on schedule, the second outcomes are the incidence of 3-4 grade of neutropenia, FN-related hospitalization and antibiotic use, incidence of reduction and delay of chemotherapy dose, safety and pharmacoeconomics of PEG-rhG-CSF.
- Conditions
- Chemotherapy-induced Neutropenia
- Being tested
- PEG-rhG-CSF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEG-rhG-CSFDrug
All patients need to receive PEG-rhG-CSF 6mg approximately 24h or 48h after chemotherapy administration once per cycle, at least 2 cycles
| Study group | Role | What they receive |
|---|---|---|
| PEG-rhG-CSF primary prophylaxis | Patients receiving chemotherapy who have a overall FN risk >=20% receive PEG-rhG-CSF for primary prophylaxis Receives: Drug: PEG-rhG-CSF | |
| PEG-rhG-CSF secondary prophylaxis | Patients receiving chemotherapy who had FN or dose-limited neutropenia receive PEG-rhG-CSF for secondary prophylaxis Receives: Drug: PEG-rhG-CSF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of FN rate
FN was defined as fever >=38.3°C orally (>=38.0°C for a duration over 2h) or axillary temperature >=38.1°C (>=37.8°C for a duration over 2h) and ANC < 0.5 X 10*9/L
Measured: through study completion, an average of 2 year
Proportion of patients completing chemotherapy on schedule
proportion of patients completing chemotherapy on schedule
Measured: through study completion, an average of 2 year
Secondary outcomes (2)
Incidence of 3-4 grade of neutropenia
the second outcomes are the incidence of 3-4 grade of neutropenia
Measured: through study completion, an average of 2 year
FN-related hospitalization and antibiotic use
FN-related hospitalization and antibiotic use
Measured: through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2018
- Study startOct 2018 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-induced NeutropeniaStudies of the same condition, open and under way.
- More trials run by Anhui Provincial HospitalThe 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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Yue-Yin Pan, Anhui Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03701841
- Sponsor's protocol ID
- AHP-PSPRWS
- Status last verified
- Oct 2018
- First submitted
- 27 Sep 2018
- Last updated
- 10 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy, Safety and Cost-effectiveness of PEG-rhG-CSF for Primary Prophylaxis Versus Secondary Prophylaxis of Chemotherapy Induced Neutropenia in Patients Receiving Chemotherapy With High-risk FN: a Real World Study
- ClinicalTrials.gov ID
- NCT03701841
- Acronym / sponsor ID
- AHP-PSPRWS
- Conditions
- Chemotherapy-induced Neutropenia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Anhui Provincial HospitalOther government
- Study start
- Oct 2018 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 10 Oct 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.
This trial is a multicenter, non-interventional, registered real-world clinical study. Based on available evidence and recommendations of guidelines, tumor patients with high risk of FN and eligible for all enrollment criteria were recruited into primary prophylaxis of PEG-rhG-CSF or secondary prophylaxis of PEG-rhG-CSF according to the real-world clinical pathway without randomization. All patients need to receive at least 2 cycles of PEG-rhG-CSF prophylaxis. Researchers will record the incidence of FN, RDI, FN-related hospitalization, antibiotic use, direct medical care and indirect medical care cost under the real clinical conditions, and assess the efficacy, safety and cost-effectiveness of PEG-rhG-CSF primary prophylaxis versus secondary prophylaxis through sub-group analysis and exploratory research.
Detailed description
Patients with cancer planning for chemotherapy assessed with high risk of febrile neutropenia (FN) according to NCCN and ASCO guidelines are recruited, receiving primary or secondary prophylaxis of PEG-rhG-CSF according to real-world clinical pathway in local cancer center for at least 4 cycles of chemotherapy. The primary outcome is the incidence of FN rate and proportion of patients completing chemotherapy on schedule, the second outcomes are the incidence of 3-4 grade of neutropenia, FN-related hospitalization and antibiotic use, incidence of reduction and delay of chemotherapy dose, safety and pharmacoeconomics of PEG-rhG-CSF.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEG-rhG-CSF primary prophylaxis | – | Drug: PEG-rhG-CSFPatients receiving chemotherapy who have a overall FN risk >=20% receive PEG-rhG-CSF for primary prophylaxis |
| PEG-rhG-CSF secondary prophylaxis | – | Drug: PEG-rhG-CSFPatients receiving chemotherapy who had FN or dose-limited neutropenia receive PEG-rhG-CSF for secondary prophylaxis |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with cancer planning for chemotherapy assessed with high risk of febrile neutropenia (FN) according to NCCN and ASCO guidelines are recruited, receiving primary or secondary prophylaxis of PEG-rhG-CSF according to real-world clinical pathway in local cancer center for at least 4 cycles of chemotherapy.
Key inclusion criteria (6 listed)
- Before the start of the study, all patients have been fully understood the research and the must sign the informed consent
- Aged 13 years or older
- accept at least 4 cycles of chemotherapy
- ECOG PS 0-2
- expected survival time ≥ 3 months
Key exclusion criteria (12 listed)
- accepted stem cell or bone marrow transplant
- undergoing any other clinical trial
- uncontrolled infection, temperature≥38℃
- per-week scheme chemotherapy
- severe and uncontrolled diabetes
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 |
|---|---|---|
| PEG-rhG-CSFAll patients need to receive PEG-rhG-CSF 6mg approximately 24h or 48h after chemotherapy administration once per cycle, at least 2 cycles | Drug | PEG-rhG-CSF primary prophylaxis, PEG-rhG-CSF secondary prophylaxis |
Primary outcome
Incidence of FN rate
Time frame: through study completion, an average of 2 year
FN was defined as fever >=38.3°C orally (>=38.0°C for a duration over 2h) or axillary temperature >=38.1°C (>=37.8°C for a duration over 2h) and ANC < 0.5 X 10*9/L
Proportion of patients completing chemotherapy on schedule
Time frame: through study completion, an average of 2 year
proportion of patients completing chemotherapy on schedule
2 secondary outcomes
Incidence of 3-4 grade of neutropenia
Time frame: through study completion, an average of 2 year
FN-related hospitalization and antibiotic use
Time frame: through study completion, an average of 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2018.
- Individual participant dataSharing planned: Undecided
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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.
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 Chemotherapy-induced Neutropenia, run by Anhui Provincial Hospital at 1 site in China.
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 6 inclusion and 12 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 10 Oct 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 China. 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 Yueyin Pan, PhD (86-551-62283411, yueyinpan1965@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of FN rate (time frame: through study completion, an average of 2 year). The study lists 2 primary outcomes in all. 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 10 Oct 2018.