Risk Factors and Long-term Impact of ICIs

NCT05754983 | Active Not Recruiting DMC

• 1 other identifier: XJTU1AF2022LSL-020
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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 events and health status to build a disease cohort database based on patient reports, and then analyze the risk factors affecting the efficacy, prognosis and adverse events 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 events after immunotherapy, and the further improvement of survival prognosis of patients

Conditions

Malignant Neoplasm

Outcome Measures

Primary Outcomes (1)

• Progression-Free-Survival (PFS)

  It refers to the time from randomization to disease progression

  Two years

Interventions

Solid tumor patients receiving immunotherapy for the first time were included in the study DRUG

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The included population is malignant solid tumor patients receiving immunotherapy for the first time

You may qualify if:

• 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

You may not qualify if:

• Previous medical history of other malignant tumors;
• 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

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (1)

First Affiliated Hospitap of Xian Jiaotong University

Xi’an, Shanxi, 710061, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Peripheral blood sample, cancer tissue

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2023
• First Posted: March 6, 2023
• Study Start: November 24, 2022
• Primary Completion: December 30, 2024
• Study Completion: December 31, 2025
• Last Updated: February 7, 2025

Record last verified: 2024-08

Locations

CN (1)