A Real World Study Evaluating the Clinical Application of PEG-rhG-CSF During Chemotherapy in Patients With Solid Tumors

Neutropenia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03798665
• Other study ID #: CB-RWS
• Status: Recruiting
• Start date: July 6, 2018
• Est. completion date: July 6, 2019

Study information

• Verified date: January 2019
• Source: Af?liated Hospital of North Sichuan Medical College
• Contact: Xian Bang Tan
• Phone: 13458406996
• Email: tbx-n9mB[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: July 6, 2019
• Est. primary completion date: July 6, 2019
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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.

Exclusion Criteria:

1. PEG-rhG-CSF was used in the current chemotherapy cycle;

2. Have received hematopoietic stem cell transplantation or bone marrow transplantation;

3. Other drug clinical trials are currently underway.

Related Conditions & MeSH terms

• Neutropenia

Intervention

Drug:
• 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

Locations

Country	Name	City	State
China	Affiliated Hospital of North Sichuan Medical College	Nanchong	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Af?liated Hospital of North Sichuan Medical College

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dosage of PEG-rhG-CSF in chemotherapy		1 YEAR
Primary	Administration time of PEG-rhG-CSF in chemotherapy		1 YEAR
Primary	dosing frequency of PEG-rhG-CSF in chemotherapy		1 YEAR