NeutropeniaNCT03798665
A Real World Study Evaluating the Clinical Application of PEG-rhG-CSF During Chemotherapy in Patients With Solid Tumors
An observational study of Neutropenia, run by Affiliated Hospital of North Sichuan Medical College at 1 site in China.
Trial summary
Prospective, multicenter, non-interventional registration studies were used in this project . Eight hundreds patients with solid tumors who met the inclusion criteria in six hospitals in Sichuan Province, Sichuan Province, were selected from the first chemotherapy cycle using PEG-rhG-CSF (can be any chemotherapy cycle… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neutropenia
- What is being tested?
- Pegfilgrastim（PEG-rhG-CSF）
- How many people
- 800 participants
- Where
- 1 siteChina
- Study dates
- 6 Jul 2018to 6 Jul 2019
- 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
- Adult, Older adult
Study population: 1. Age ≥ 18 years old; 2. Diagnosed as a malignant solid tumor by histology and cytology, requiring chemotherapy patients; 3. The first use of PEG-rhG-CSF during the chemotherapy cycle (not limited to the first chemotherapy cycle, can be any chemotherapy cycle of the patient); 4. Subjects volunteered to participate in this clinical trial and signed informed consent.
Who may be able to join
- Age ≥ 18 years old;
- Diagnosed as a malignant solid tumor by histology and cytology, requiring chemotherapy patients;
- The first use of PEG-rhG-CSF during the chemotherapy cycle (not limited to the first chemotherapy cycle, can be any chemotherapy cycle of the patient);
- Subjects volunteered to participate in this clinical trial and signed informed consent.
Who cannot join
- PEG-rhG-CSF was used in the current chemotherapy cycle;
- Have received hematopoietic stem cell transplantation or bone marrow transplantation;
- Other drug clinical trials are currently underway.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Affiliated Hospital of North Sichuan Medical College
Nanchong, Sichuan
Xian Bang Tan, 13458406996, tbx-n9mB@126.com
About this study
Official title: A Prospective, Multicenter, Non-interventional Registry Study Evaluating the Clinical Application of PEG-rhG-CSF During Chemotherapy in Patients With Malignant Solid Tumors in Sichuan
Prospective, multicenter, non-interventional registration studies were used in this project . Eight hundreds patients with solid tumors who met the inclusion criteria in six hospitals in Sichuan Province, Sichuan Province, were selected from the first chemotherapy cycle using PEG-rhG-CSF (can be any chemotherapy cycle of the patient), and each subsequent chemotherapy cycle was recorded. The use of PEG-rhG-CSF and related patient outcomes until the end of chemotherapy. Analyze the clinical practice of using PEG-rhG-CSF in the real world.
- Conditions
- Neutropenia
- Being tested
- Pegfilgrastim（PEG-rhG-CSF）
- Medical subject headings
- Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pegfilgrastim（PEG-rhG-CSF）Drug
From the first chemotherapy cycle using PEG-rhG-CSF (which can be any chemotherapy cycle of the patient), record the use of PEG-rhG-CSF in this cycle and each subsequent chemotherapy cycle, including dosage, administration time and dosing frequency
What is being measured
The primary outcome is the main question the study is designed to answer.
Dosage of PEG-rhG-CSF in chemotherapy
Measured: 1 YEAR
Administration time of PEG-rhG-CSF in chemotherapy
Measured: 1 YEAR
dosing frequency of PEG-rhG-CSF in chemotherapy
Measured: 1 YEAR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2019
- Study start6 Jul 2018
- Primary completion6 Jul 2019 (estimated)
- Study completion6 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeutropeniaStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of North Sichuan Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DaiYuan Ma, Affiliated Hospital of North Sichuan Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03798665
- Sponsor's protocol ID
- CB-RWS
- Status last verified
- Jan 2019
- First submitted
- 8 Jan 2019
- Last updated
- 10 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Non-interventional Registry Study Evaluating the Clinical Application of PEG-rhG-CSF During Chemotherapy in Patients With Malignant Solid Tumors in Sichuan
- ClinicalTrials.gov ID
- NCT03798665
- Acronym / sponsor ID
- CB-RWS
- Conditions
- Neutropenia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Affiliated Hospital of North Sichuan Medical CollegeUniversity, hospital or other
- Study start
- 6 Jul 2018 (actual)
- Primary completion
- 6 Jul 2019 (estimated)
- Study completion
- 6 Jul 2019 (estimated)
- First posted
- 10 Jan 2019 (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.
Prospective, multicenter, non-interventional registration studies were used in this project . Eight hundreds patients with solid tumors who met the inclusion criteria in six hospitals in Sichuan Province, Sichuan Province, were selected from the first chemotherapy cycle using PEG-rhG-CSF (can be any chemotherapy cycle of the patient), and each subsequent chemotherapy cycle was recorded. The use of PEG-rhG-CSF and related patient outcomes until the end of chemotherapy. Analyze the clinical practice of using PEG-rhG-CSF in the real world.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 1. Age ≥ 18 years old; 2. Diagnosed as a malignant solid tumor by histology and cytology, requiring chemotherapy patients; 3. The first use of PEG-rhG-CSF during the chemotherapy cycle (not limited to the first chemotherapy cycle, can be any chemotherapy cycle of the patient); 4. Subjects volunteered to participate in this clinical trial and signed informed consent.
Key inclusion criteria (4 listed)
- Age ≥ 18 years old;
- Diagnosed as a malignant solid tumor by histology and cytology, requiring chemotherapy patients;
- The first use of PEG-rhG-CSF during the chemotherapy cycle (not limited to the first chemotherapy cycle, can be any chemotherapy cycle of the patient);
- Subjects volunteered to participate in this clinical trial and signed informed consent.
Key exclusion criteria (3 listed)
- PEG-rhG-CSF was used in the current chemotherapy cycle;
- Have received hematopoietic stem cell transplantation or bone marrow transplantation;
- Other drug clinical trials are currently underway.
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 |
|---|---|---|
| Pegfilgrastim（PEG-rhG-CSF）From the first chemotherapy cycle using PEG-rhG-CSF (which can be any chemotherapy cycle of the patient), record the use of PEG-rhG-CSF in this cycle and each subsequent chemotherapy cycle, including dosage, administration time and dosing frequency | Drug | – |
Primary outcome
Dosage of PEG-rhG-CSF in chemotherapy
Time frame: 1 YEAR
Administration time of PEG-rhG-CSF in chemotherapy
Time frame: 1 YEAR
dosing frequency of PEG-rhG-CSF in chemotherapy
Time frame: 1 YEAR
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2019.
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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 Neutropenia, run by Affiliated Hospital of North Sichuan Medical College 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 4 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: status not confirmed, as of the sponsor's last update on 10 Jan 2019. 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 Xian Bang Tan (13458406996, tbx-n9mB@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dosage of PEG-rhG-CSF in chemotherapy (time frame: 1 YEAR). The study lists 3 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 Jan 2019.