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

NCT03798665 | Unknown

• 1 other identifier: CB-RWS
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neutropenia

Outcome Measures

Primary Outcomes (3)

• 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

Interventions

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Affiliated Hospital of North Sichuan Medical College: lead

Study Sites (1)

Affiliated Hospital of North Sichuan Medical College

Nanchong, Sichuan, China

RECRUITING

MeSH Terms

Conditions

Neutropenia

Condition Hierarchy (Ancestors)

Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders

Central Study Contacts

Xian Bang Tan

CONTACT

13458406996; tbx-n9mB@126.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Cancer Center Affiliation: Affiliated Hospital of North Sichuan Medical College

Study Record Dates

• First Submitted: January 8, 2019
• First Posted: January 10, 2019
• Study Start: July 6, 2018
• Primary Completion: July 6, 2019
• Study Completion: July 6, 2019
• Last Updated: January 10, 2019

Record last verified: 2019-01

Locations

CN (1)