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

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.

Study Overview

• Status: Unknown
• Conditions: Neutropenia
• Intervention / Treatment: Drug: Pegfilgrastim（PEG-rhG-CSF）

• Study Type: Observational
• Enrollment (Anticipated): 800

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Nanchong, Sichuan, China
      • Recruiting
      • Affiliated Hospital of North Sichuan Medical College
      • Contact: Xian Bang Tan; Phone Number: 13458406996; Email: tbx-n9mB@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Dosage of PEG-rhG-CSF in chemotherapy	1 YEAR
Administration time of PEG-rhG-CSF in chemotherapy	1 YEAR
dosing frequency of PEG-rhG-CSF in chemotherapy	1 YEAR

Collaborators and Investigators

• Sponsor: Affiliated Hospital of North Sichuan Medical College

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2018
• Primary Completion (Anticipated): July 6, 2019
• Study Completion (Anticipated): July 6, 2019

Study Registration Dates

• First Submitted: January 8, 2019
• First Submitted That Met QC Criteria: January 8, 2019
• First Posted (Actual): January 10, 2019

Study Record Updates

• Last Update Posted (Actual): January 10, 2019
• Last Update Submitted That Met QC Criteria: January 8, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Agranulocytosis; Leukopenia; Leukocyte Disorders; Neutropenia
• Other Study ID Numbers: CB-RWS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No