Construction of a Database of Prognostic Risk Factors and Quality of Life of Patients With Primary Solid Malignant Cancers Receiving Immunotherapy for the First Time Based on Questionnaire Survey

Malignant Neoplasm Clinical Trial

Official title:

Evaluation of Prognostic Risk Factors and Long-term Health Impact of Immunotherapy Patients Based on Special Disease Cohort Registered by Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05754983
• Other study ID #: XJTU1AF2022LSL-020
• Status: Recruiting
• Start date: November 24, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2023
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: Min Jiao, Doctor
• Phone: 0086-13571813480
• Email: jiaomin3650000[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study plans to conduct a multicenter, observable and controlled cohort study to solid-tumor patients with receiving immunotherapy and to collect information about their treatment related efficacy, adverse reactions and health status to build a prospective disease cohort database based on patient reports, and then analyze the risk factors affecting the efficacy and prognosis of immunotherapy and the impact of immunotherapy on health status.It is expected to provide high-level evidence-based medical evidence for the selection of immunotherapy schemes for these patients, the precise prevention and health management of adverse reactions after immunotherapy, and the further improvement of survival prognosis of patients

Description:

This study is intended to conduct a multicenter, observable and controlled cohort study in multiple clinical centers including the First Affiliated Hospital of Xi'an Jiaotong University to solid-tumor patients who received immunotherapy for the first time, The baseline information before treatment was collected (mainly including three collection methods, namely, patients' self filling information, physician assisted filling information, and medical record system import information. The information collected was mainly in the following aspects: demographic characteristics, tumor and anti-tumor information, gene testing information, blood sample collection information, and questionnaire evaluation information) and follow-up information after treatment (The collection method and content are the same as the baseline information.) Collect the relevant factors that may affect the treatment efficacy and prognosis of patients, build a prospective disease cohort database based on patient reports, and then analyze the risk factors that affect the efficacy and prognosis of immunotherapy and the impact of immunotherapy on health status. The outcome indicators are mainly disease free progression survival (PFS), The secondary indicators were the total survival period (OS) and the scoring results of various questionnaires (PHQ-9, etc).It is expected to provide high-level evidence-based medical evidence for the selection of immunotherapy schemes for these patients, the precise prevention and health management of adverse reactions after immunotherapy, and the further improvement of survival prognosis of patients

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age range of subjects: the age of subjects is no less than 18 years old;
• Receiving any ICIs treatment or ICIs combined with other treatments;
• Soild malignant tumor proved by pathology (histology or cytology);
• First treatment with ICIs {including ICIs (first) combined with other treatments)};
• Any stage and treatment line (new auxiliary, auxiliary and advanced treatment)
• Willing to treat, and can come to the hospital regularly in the later period

Exclusion Criteria:

• Previous medical history of other malignant tumors;
• Liver/lung metastasis;
• No pathology (histology or cytology) certificate;
• Having received ICIs or other immunotherapy in the past;
• Participated in clinical research in the past and may have applied ICIs or other immunotherapy;
• Weak treatment intention or long-term treatment in other hospitals/departments

Related Conditions & MeSH terms

• Malignant Neoplasm
• Neoplasms

Intervention

Drug:
• Solid tumor patients receiving immunotherapy for the first time were included in the study
Solid tumor patients receiving immunotherapy were included in the study. Baseline information before treatment (including demographic characteristics, basic diseases and their medication history, tumor and anti-tumor history, quality of life scores, etc.) and follow-up information after treatment (PFS, OS, etc.) were collected to summarize factors that may affect the efficacy and prognosis of patients receiving immunotherapy

Locations

Country	Name	City	State
China	First Affiliated Hospitap of Xian Jiaotong University	Xi'an	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-Free-Survival (PFS)	It refers to the time from randomization to disease progression	Two years